Re: [PSES] FW: Testing to IEC 60601-1-2-2014 + A1-2020

[T.Sato]

On Wed, 10 Mar 2021 07:03:43 +,
  David Shidlovsky  wrote:

> Any opinions as to when testing conducted and radiated missions of a medical 
> device being tested to IEC 60601-1-2 can be performed to CISPR 14-1 or CISPR 
> 32 instead of CISPR 11?
> Would it be more appropriate to test a medical device used in home health 
> care environment using CISPR 14-1 instead of CISPR 11 since CISPR 14-1 is 
> four household devices?
> Any ideas as to when testing using CISPR 32 instead of CISPR 11 is 
> appropriate. Many modern medical devices/systems incorporate multimedia 
> devices (some of which have not been tested to CISPR 32).

CISPR 14-1 is applicable to ME EQUIPMENT whose main functions are performed
by motors and switching or regulating devices. Examples include motor-driven
electromedical apparatus such as simple dental drills and simple operation
tables. (see clause 7.1.7)

CISPR 32 is applicable to multimedia equipment connected to ME EQUIPMENT and
ME SYSTEMS. (see clause 7.1.3)
For example, personal computer, external LCD mointor, video recorder,
network equipments which comply with CISPR 32 may be connected to
me equipment without re-testing them with CISPR 11.

Regards,
Tom

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] FW: Testing to IEC 60601-1-2-2014 + A1-2020

[David Shidlovsky]

Hi
Any opinions as to when testing conducted and radiated missions of a medical 
device being tested to IEC 60601-1-2 can be performed to CISPR 14-1 or CISPR 32 
instead of CISPR 11?
Would it be more appropriate to test a medical device used in home health care 
environment using CISPR 14-1 instead of CISPR 11 since CISPR 14-1 is four 
household devices?
Any ideas as to when testing using CISPR 32 instead of CISPR 11 is appropriate. 
Many modern medical devices/systems incorporate multimedia devices (some of 
which have not been tested to CISPR 32).
Thanks in advance to anyone who responds.

Best Regards,
David Shidlowsky
Technical Reviewer
[cid:image001.jpg@01D7158B.AD8793E0]
Address 1 Bat-Sheva St. POB 6117, LOD7120101   Israel
Tel: 972-8-9186100 Ext. 213 Direct: 972-8-9186113   Fax: 972-8-9153101
Mail: dav...@itlglobal.org<mailto:dav...@itlglobal.org>   Web 
www.itlglobal.org<http://www.itlglobal.org/>

[cid:image002.png@01D7158B.AD8793E0]Waze ITL: https://waze.com/ul/hsv8vccn2j




-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] Testing to IEC 60601-1-2

[Charlie Blackham]

David

My understanding is this:


  *   ME equipment is defined in EN 60601-1 clause 3.63 and includes those 
ACCESSORIES as defined by the MANUFACTURER that are necessary to enable the 
NORMAL USE of the ME EQUIPMENT.
  *   7.1.3 is for multimedia and ITE equipment "connected to", not "part of", 
ME equipment
  *   The manufacturer should know what is what and should be defining the 
system and the test plan

Best regards
Charlie

Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317
Web: https://sulisconsultants.com/
Registered in England and Wales, number 05466247

From: David Shidlovsky 
Sent: 08 February 2021 17:06
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Testing to IEC 60601-1-2

Hello
IEC 60601-1-2 allows testing of conducted and radiated emissions to CISPR 11; 
CISPR 14-11; CISPR 32.
Concerning the use of CISPR 32:
According to Clause 7.1.1 General:
"Unless otherwise specified herein, ME 
EQUIPMENT and ME SYSTEMS shall comply with CISPR 11"
According to Clause 7.1.3 Multimedia equipment:
"Multimedia equipment connected to ME EQUIPMENT and ME SYSTEMS shall comply 
with CISPR 32. If CISPR 32 class A equipment is supplied as part of an ME 
SYSTEM, the ME SYSTEM shall be classified class A."
A number of modern medical equipment includes devices that are clearly 
multimedia equipment.
Are there any published guidelines for indicating when testing medical 
equipment that includes multimedia devices to CISPR 32 instead of CISPR 11?

Best Regards,
David Shidlowsky
Technical Reviewer
[cid:image001.jpg@01D6FE57.7288DBF0]
Address 1 Bat-Sheva St. POB 6117, LOD7120101   Israel
Tel: 972-8-9186100 Ext. 213 Direct: 972-8-9186113   Fax: 972-8-9153101
Mail: dav...@itlglobal.org<mailto:dav...@itlglobal.org>   Web 
www.itlglobal.org<http://www.itlglobal.org/>

[cid:image002.png@01D6FE57.7288DBF0]Waze ITL: https://waze.com/ul/hsv8vccn2j


-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)<http://www.ieee-pses.org/list.html>
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] Testing to IEC 60601-1-2

[David Shidlovsky]

Hello
IEC 60601-1-2 allows testing of conducted and radiated emissions to CISPR 11; 
CISPR 14-11; CISPR 32.
Concerning the use of CISPR 32:
According to Clause 7.1.1 General:
"Unless otherwise specified herein, ME 
EQUIPMENT and ME SYSTEMS shall comply with CISPR 11"
According to Clause 7.1.3 Multimedia equipment:
"Multimedia equipment connected to ME EQUIPMENT and ME SYSTEMS shall comply 
with CISPR 32. If CISPR 32 class A equipment is supplied as part of an ME 
SYSTEM, the ME SYSTEM shall be classified class A."
A number of modern medical equipment includes devices that are clearly 
multimedia equipment.
Are there any published guidelines for indicating when testing medical 
equipment that includes multimedia devices to CISPR 32 instead of CISPR 11?

Best Regards,
David Shidlowsky
Technical Reviewer
[cid:image001.jpg@01D6FE4D.6645B6B0]
Address 1 Bat-Sheva St. POB 6117, LOD7120101   Israel
Tel: 972-8-9186100 Ext. 213 Direct: 972-8-9186113   Fax: 972-8-9153101
Mail: dav...@itlglobal.org<mailto:dav...@itlglobal.org>   Web 
www.itlglobal.org<http://www.itlglobal.org/>

[cid:image002.png@01D6FE4D.6645B6B0]Waze ITL: https://waze.com/ul/hsv8vccn2j



-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2: 2014 Testing on Device Powered from Computer USB Port

[Leo Eisner]

Connecting a computer to a medical device does impact basic safety.  Reason is 
it raises the Leakage current of the system unless proper isolation provided 
(refer to Clause 16 and Annex I of 60601-1).  Basic Safety comes out of IEC 
60601-1 not from IEC 60601-1-2

Several issues many emc test labs are not doing correctly is requiring the 
manufacturer to provide the EMC test plan per IEC 60601-1-2, 4th ed (2014) & 
per the FDA Guidance, and the Essential Performance analysis is not provided 
the test lab tends to test to IEC 60601-1-2, 3rd ed. Requirements which is 
incorrect.  Having proper Essential Performance Requirements (which has to be 
the manufacturer’s responsibility) can have a huge impact on the emc testing.

Cheers,
Leonard (Leo) Eisner, P.E.
The “IEC 60601 Guy”
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151 
Mobile: (503) 709-8328 
Email: l...@eisnersafety.com <mailto:l...@eisnersafety.com>
Website: www.EisnerSafety.com <http://www.eisnersafety.com/>
 <http://www.eisnersafety.com/Industry_News/>  
<http://us.linkedin.com/in/leoeisnersafetyconsultants>  
<http://www.twitter.com/EisnerSafety>  
<http://skype:Eisner_Safety_Consultants/>  <http://plus.google.com/+LeoEisner>  
<http://www.youtube.com/channel/UC6obaID27sjS-bbk0qv0AmQ>
*** Internet E-mail Confidentiality Disclaimer ***
This e-mail message may contain privileged or confidential information. If you 
are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.

Eisner Safety Consultants do not accept liability for any errors, omissions, 
corruption or virus in the contents of this message or any attachments that 
arise as a result of e-mail transmission.
***

> On Jul 16, 2019, at 2:07 AM, John Woodgate  wrote:
> 
> I wouldn't use a generic laptop, just because that could be questioned. Is it 
> not possible to use one of the manufacturer-designated laptops? That can't be 
> reasonably questioned.
> 
> Best wishes
> John Woodgate OOO-Own Opinions Only
> J M Woodgate and Associates www.woodjohn.uk <http://www.woodjohn.uk/>
> Rayleigh, Essex UK
> On 2019-07-16 07:55, itl-emc user group wrote:
>> Hi,
>> One of our customers manufactures a medical device that is connected to a 
>> USB port of a laptop/Personal Computer.
>> The USB port provides both DC and communication to the device.
>> The connected laptop/PC has no relation to the Basic Safety or Essential 
>> Performance of the device.
>> The manufacturer requires end users to use only approved laptops/PC’s (not 
>> necessarily approved for the MDD).
>> Testing will be performed using a generic laptop.
>> Since the laptop/pc does not affect the basic safety or essential 
>> performance of the device, can all testing relating to the AC power of the 
>> laptop/pc (power lines conducted emissions, harmonics, flickers, EFFT/B, 
>> surges, conducted RF disturbances, and voltage dips And short interruptions) 
>> be omitted. Laptop/PC designated as auxiliary equipment.
>> All opinions welcome.
>>  
>> Regards,
>> David Shidlowsky | Technical Reviewer
>> 
>> Mail  : dav...@itlglobal.org <mailto:dav...@itlglobal.org>/dav...@itl.co. 
>> <mailto:dav...@itl.co.il>
>>  
>>  
>>  
>>  
>>  
>> -
>> 
>> This message is from the IEEE Product Safety Engineering Society emc-pstc 
>> discussion list. To post a message to the list, send your e-mail to 
>> mailto:emc-p...@ieee.org>>
>> 
>> All emc-pstc postings are archived and searchable on the web at: 
>> http://www.ieee-pses.org/emc-pstc.html 
>> <http://www.ieee-pses.org/emc-pstc.html>
>> Attachments are not permitted but the IEEE PSES Online Communities site at 
>> http://product-compliance.oc.ieee.org/ 
>> <http://product-compliance.oc.ieee.org/> can be used for graphics (in 
>> well-used formats), large files, etc.
>> 
>> Website: http://www.ieee-pses.org/ <http://www.ieee-pses.org/>
>> Instructions: http://www.ieee-pses.org/list.html (including how to 
>> unsubscribe) <http://www.ieee-pses.org/list.html>
>> List rules: http://www.ieee-pses.org/listrules.html 
>> <http://www.ieee-pses.org/listrules.html>
>> For help, send mail to the list administrators:
>> Scott Douglas mailto:sdoug...@ieee.org>>
>> Mike Cantwell mailt

Re: [PSES] IEC 60601-1-2: 2014 Testing on Device Powered from Computer USB Port

[John Woodgate]

I wouldn't use a generic laptop, just because that could be questioned. 
Is it not possible to use one of the manufacturer-designated laptops? 
That can't be reasonably questioned.


Best wishes
John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK

On 2019-07-16 07:55, itl-emc user group wrote:


Hi,

 1. One of our customers manufactures a medical device that is
connected to a USB port of a laptop/Personal Computer.
 2. The USB port provides both DC and communication to the device.
 3. The connected laptop/PC has no relation to the Basic Safety or
Essential Performance of the device.
 4. The manufacturer requires end users to use only approved
laptops/PC’s (not necessarily approved for the MDD).
 5. Testing will be performed using a generic laptop.
 6. Since the laptop/pc does not affect the basic safety or essential
performance of the device, can all testing relating to the AC
power of the laptop/pc (power lines conducted emissions,
harmonics, flickers, EFFT/B, surges, conducted RF disturbances,
and voltage dips And short interruptions) be omitted. Laptop/PC
designated as auxiliary equipment.
 7. All opinions welcome.

*Regards,***

*David Shidlowsky***| Technical Reviewer

*Mail*: dav...@itlglobal.org 
/dav...@itl.co. 


-


This message is from the IEEE Product Safety Engineering Society 
emc-pstc discussion list. To post a message to the list, send your 
e-mail to mailto:emc-p...@ieee.org>>


All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html


Attachments are not permitted but the IEEE PSES Online Communities 
site at http://product-compliance.oc.ieee.org/ can be used for 
graphics (in well-used formats), large files, etc.


Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>



-

This message is from the IEEE Product Safety Engineering Society emc-pstc discussion 
list. To post a message to the list, send your e-mail to 

All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] IEC 60601-1-2: 2014 Testing on Device Powered from Computer USB Port

[itl-emc user group]

Hi,

  1.  One of our customers manufactures a medical device that is connected to a 
USB port of a laptop/Personal Computer.
  2.  The USB port provides both DC and communication to the device.
  3.  The connected laptop/PC has no relation to the Basic Safety or Essential 
Performance of the device.
  4.  The manufacturer requires end users to use only approved laptops/PC's 
(not necessarily approved for the MDD).
  5.  Testing will be performed using a generic laptop.
  6.  Since the laptop/pc does not affect the basic safety or essential 
performance of the device, can all testing relating to the AC power of the 
laptop/pc (power lines conducted emissions, harmonics, flickers, EFFT/B, 
surges, conducted RF disturbances, and voltage dips And short interruptions) be 
omitted. Laptop/PC designated as auxiliary equipment.
  7.  All opinions welcome.

Regards,
David Shidlowsky | Technical Reviewer
Mail  : 
dav...@itlglobal.org/dav...@itl.co.







-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] Artificial hand - testing medical device 60601-1-2

[Amund Westin]

In EN60601-1-2, chapter 4.3.2, it describes an Artificial hand (RC element +
metal foil) that shall be under emission testing, and the  shall be
connected to the Patient coupling points.

 

It this Artificial hand something that the labs are making them self?

 

 

Best regards 

Amund Westin

 


-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2: 2014 4th Edition

[John Woodgate]

It depends on the opinion of the regulatory authority in the country of 
sale. In Europe(applying the EN versions), it is the manufacturer's 
responsibility to justify and document the decision on partial testing,


John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK

On 2018-04-22 06:30, itl-emc user group wrote:


Hi,

A question has arisen concerning grandfathering to the IEC 60601-1-2: 
2007 3^rd Edition.


If a device has met the requirements of IEC 60601-1-2: 2007 3^rd 
edition, is it acceptable to only test for the additional requirements 
of IEC 60601-1-2: 2014 4^th Edition? Can a manufacturer then claim 
compliance to the Edition 4?


A lot of customers only want partial testing even when full testing is 
recommended.


Opinions?

*Regards,***

*David Shidlowsky***| Technical Reviewer

*Address*1 Bat-Sheva St. LOD 7120101 Israel

*Tel*972-8-9186113*Fax* 972-8-9153101

*Mail*: dav...@itlglobal.org 
<mailto:dav...@itlglobal.org>/dav...@itl.co.il <mailto:dav...@itl.co.il>


This e-mail message may contain privileged or confidential information.

If you are not the intended recipient, you may not disclose, use, 
disseminate, distribute, copy or rely upon this message or attachment 
in any way. If you received this e-mail message in error, please 
return by forwarding the message and its attachments to the sender.


-


This message is from the IEEE Product Safety Engineering Society 
emc-pstc discussion list. To post a message to the list, send your 
e-mail to mailto:emc-p...@ieee.org>>


All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html


Attachments are not permitted but the IEEE PSES Online Communities 
site at http://product-compliance.oc.ieee.org/ can be used for 
graphics (in well-used formats), large files, etc.


Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>




-

This message is from the IEEE Product Safety Engineering Society emc-pstc discussion 
list. To post a message to the list, send your e-mail to 

All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] IEC 60601-1-2: 2014 4th Edition

[itl-emc user group]

Hi,
A question has arisen concerning grandfathering to the IEC 60601-1-2: 2007 3rd 
Edition.
If a device has met the requirements of IEC 60601-1-2: 2007 3rd edition, is it 
acceptable to only test for the additional requirements of IEC 60601-1-2: 2014 
4th Edition? Can a manufacturer then claim compliance to the Edition 4?
A lot of customers only want partial testing even when full testing is 
recommended.
Opinions?


Regards,
David Shidlowsky | Technical Reviewer
Address 1 Bat-Sheva St. LOD 7120101 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail : 
dav...@itlglobal.org<mailto:dav...@itlglobal.org>/dav...@itl.co.il<mailto:dav...@itl.co.il>

This e-mail message may contain privileged or confidential information.
If you are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.



-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2: 2014 Basic Safety and Essential Performance Pass/Fail Criteria

[Leo Eisner]

Hello All,

First I would ask the client to prove they have no Essential Performance for 
their device.  This is done by having them show that they did a full analysis 
against IEC 60601-1:2005 + A1:2012 clause 4.3 which is the process needed to 
show they do or don’t have Essential Performance.  
Note, in the last year plus the FDA has been stickler for asking manufacturers 
(submitters) to prove if they have Essential Performance (EP) or not.  I had 2 
decent size projects late 2016 - mid 2017 to help 2 clients that claimed no 
Essential Performance and turned out one really did have several EP’s while the 
other one added in and so both had to retest products to IEC 60601-1 & 
60601-1-2 (costly mistake and slowed down product release as both couldn’t sell 
til after formal approval by FDA).  Dare I say it, part of the fault of the 
clients going so far down the path is the test labs don’t question when no EP 
in most cases (both EMC and safety labs - both client cases we are even talking 
top tier safety test labs).

Second as mentioned earlier a Risk Analysis needs to be done as part of the 
manufacturers test plan (the mfr knows their product better than any test lab 
and they have to do Risk Analysis per ISO 14971:2007 per IEC 60601 series of 
standards) so this needs to be considered in their Test plan which incorporates 
the Risk Analysis.The EP analysis that is done per clause 4.3 of IEC 
60601-1 is interrelated to Risk Analysis so EP will show in the Risk Analysis.  

Lastly, if a product falls under the scope of IEC 60601-1 and IEC 60601-1-2 
that product will always have Basic Safety as EP is everything else in the 
standard series other than Basic Safety.  Basic Safety is all the 
constructional, mechanical, electrical, etc. requirements & tests that are not 
EP related.

Happy New Year to one and all,
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151 
Mobile: (503) 709-8328 
Email: l...@eisnersafety.com <mailto:l...@eisnersafety.com>
Website: www.EisnerSafety.com <http://www.eisnersafety.com/>
 <http://www.eisnersafety.com/Industry_News/>  
<http://us.linkedin.com/in/leoeisnersafetyconsultants>  
<http://www.twitter.com/EisnerSafety>  
<http://skype:Eisner_Safety_Consultants/>  <http://plus.google.com/+LeoEisner>  
<http://www.youtube.com/channel/UC6obaID27sjS-bbk0qv0AmQ>
*** Internet E-mail Confidentiality Disclaimer ***
This e-mail message may contain privileged or confidential information. If you 
are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.

Eisner Safety Consultants do not accept liability for any errors, omissions, 
corruption or virus in the contents of this message or any attachments that 
arise as a result of e-mail transmission.
***

> On Dec 30, 2017, at 11:59 AM, John Woodgate  wrote:
> 
> Looks good to me. Too often this sort of thing is not well documented, but 
> here is a welcome exception.
> 
> John Woodgate OOO-Own Opinions Only
> J M Woodgate and Associates www.woodjohn.uk <http://www.woodjohn.uk/>
> Rayleigh, Essex UK
> On 2017-12-30 16:26, Bart De Geeter wrote:
>> Hello David,
>>  
>> I would refer to the following part of the EN60601-1-2:
>>  
>> 6.1 General
>> The documentation of the tests shall contain all the information necessary 
>> to facilitate
>> adequate planning (test plan) and execution (test report) of the tests so 
>> that they can be
>> readily reproduced.
>> Compliance is checked by inspection of the test report.
>> 6.2 Test plan
>> Prior to the start of formal testing, a detailed test plan shall be provided 
>> to the test laboratory.
>> Deviations from the test plan shall be documented in the test report. See 
>> Annex G for
>> guidance on the recommended content of a test plan.
>>  
>>  
>> Annex G states  (although informative) that following information should be 
>> present as suggested minimum test plan content)
>>  
>> 3 Description of the BASIC SAFETY and ESSENTIALPERFORMANCE including a 
>> description how the BASIC SAFETY and ESSENTIAL PERFORMANCE will be monitored 
>> against the pass/fail criteria during each test
>>  
>> 13 IMMUNITY pass/fail criteria:   Specific IMMUNITY pass/fail 
>> criteria for BASIC SAFETY and ESSENTIAL PERFORMANCE as per the RISK ANALYSIS 
>> (see Annex I)
>>  
>>  
>> Hence, for your ESD case.
>>  
>> You should ask the supplier for his EMC  risk

Re: [PSES] IEC 60601-1-2: 2014 Basic Safety and Essential Performance Pass/Fail Criteria

[John Woodgate]

Looks good to me. Too often this sort of thing is not well documented, 
but here is a welcome exception.


John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK

On 2017-12-30 16:26, Bart De Geeter wrote:


Hello David,

I would refer to the following part of the EN60601-1-2:

*6.1 General*

The documentation of the tests shall contain all the information 
necessary to facilitate


adequate planning (test plan) and execution (test report) of the tests 
so that they can be


readily reproduced.

/Compliance is checked by inspection of the test report./

*6.2 Test plan*

Prior to the start of formal testing_, a detailed test plan shall be 
provided to the test laboratory_.


Deviations from the test plan shall be documented in the test report. 
See Annex G for


guidance on the recommended content of a test plan.

*Annex G states*_(although informative) that following information 
should be present as suggested minimum test plan content)_


__

3 Description of the BASIC SAFETY and ESSENTIALPERFORMANCE including a 
description how the BASIC SAFETY and ESSENTIAL PERFORMANCE will be 
monitored against the pass/fail criteria during each test


13 IMMUNITY pass/fail criteria:       Specific IMMUNITY 
pass/fail criteria for BASIC SAFETY and ESSENTIAL PERFORMANCE as per 
the RISK ANALYSIS (see AnnexI)


Hence, for your ESD case.

You should ask the supplier for his EMC  risk assesment study. (and 
his PASS/FAIL criteria for the ESD test).


If out of his study, the conclusion is that if the EUT ‘Stops’ after a 
15kV discharge, that this behaviour is acceptable and poses no ‘risk’ 
for the patient  then the test has PASSED.  In the EMC report the 
observed behaviour should be noted and your conclusion should be based 
on the provided pass/fail criteria, which is a result of the suppliers 
risk assessment.


At least, this is my interpretation of the standard. To all people on 
copy of the reflector, feel free to comment on this.


Greetings,

Bart

*Van:*itl-emc user group [mailto:itl...@itl.co.il]
*Verzonden:* donderdag 28 december 2017 7:38
*Aan:* EMC-PSTC@LISTSERV.IEEE.ORG
*Onderwerp:* [PSES] IEC 60601-1-2: 2014 Basic Safety and Essential 
Performance Pass/Fail Criteria


Hello

A manufacturer of medical equipment has declared that his device has 
no basic safety or essential requirements.


During ESD testing, the device stopped working after Air Discharges of 
±15 kV were applied.


Is this regarded as a failure according to the standard?

No Part 2 particular Safety standards are involved.

Thanks in advance for any responses.

*Regards,***

*David Shidlowsky***| Technical Reviewer

*Address*1 Bat-Sheva St. LOD 7120101 Israel

*Tel*972-8-9186113*Fax* 972-8-9153101

*Mail*: dav...@itlglobal.org 
<mailto:dav...@itlglobal.org>/dav...@itl.co.il 
<mailto:dav...@itl.co.il>/e...@itl.co.il *Web* www.itlglobal.orh 
<http://www.itlglobal.orh>


*Fill out CustomerSatisfaction Survey* 
<http://app.sqm.co.il/SitePages/Questionnaire.aspx>**


*/Global Certifications You Can Trust /*

This e-mail message may contain privileged or confidential information.

If you are not the intended recipient, you may not disclose, use, 
disseminate, distribute, copy or rely upon this message or attachment 
in any way. If you received this e-mail message in error, please 
return by forwarding the message and its attachments to the sender.






-

This message is from the IEEE Product Safety Engineering Society emc-pstc discussion 
list. To post a message to the list, send your e-mail to 

All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2: 2014 Basic Safety and Essential Performance Pass/Fail Criteria

[Bart De Geeter]

Hello David,

 

I would refer to the following part of the EN60601-1-2:

 

6.1 General

The documentation of the tests shall contain all the information necessary
to facilitate

adequate planning (test plan) and execution (test report) of the tests so
that they can be

readily reproduced.

Compliance is checked by inspection of the test report.

6.2 Test plan

Prior to the start of formal testing, a detailed test plan shall be provided
to the test laboratory.

Deviations from the test plan shall be documented in the test report. See
Annex G for

guidance on the recommended content of a test plan.

 

 

Annex G states  (although informative) that following information should be
present as suggested minimum test plan content)

 

3 Description of the BASIC SAFETY and ESSENTIALPERFORMANCE including a
description how the BASIC SAFETY and ESSENTIAL PERFORMANCE will be monitored
against the pass/fail criteria during each test

 

13 IMMUNITY pass/fail criteria:   Specific IMMUNITY pass/fail
criteria for BASIC SAFETY and ESSENTIAL PERFORMANCE as per the RISK ANALYSIS
(see Annex I)

 

 

Hence, for your ESD case.

 

You should ask the supplier for his EMC  risk assesment study.   (and his
PASS/FAIL criteria for the ESD test).

 

If out of his study, the conclusion is that if the EUT ‘Stops’ after a 15kV
discharge, that this behaviour is acceptable and poses no ‘risk’ for the
patient  then the test has PASSED.  In the EMC report the observed behaviour
should be noted and your conclusion should be based on the provided
pass/fail criteria, which is a result of the suppliers risk assessment.

 

At least, this is my interpretation of the standard. To all people on copy
of the reflector, feel free to comment on this.  

 

 

Greetings,

Bart

 

 

 

Van: itl-emc user group [mailto:itl...@itl.co.il] 
Verzonden: donderdag 28 december 2017 7:38
Aan: EMC-PSTC@LISTSERV.IEEE.ORG
Onderwerp: [PSES] IEC 60601-1-2: 2014 Basic Safety and Essential Performance
Pass/Fail Criteria

 

Hello

A manufacturer of medical equipment has declared that his device has no
basic safety or essential requirements.

During ESD testing, the device stopped working after Air Discharges of ±15
kV were applied.

Is this regarded as a failure according to the standard?

No Part 2 particular Safety standards are involved.

Thanks in advance for any responses.

 

 

Regards,

David Shidlowsky | Technical Reviewer

Address 1 Bat-Sheva St. LOD 7120101 Israel

Tel 972-8-9186113 Fax 972-8-9153101

Mail :  <mailto:dav...@itlglobal.org> dav...@itlglobal.org/
<mailto:dav...@itl.co.il> dav...@itl.co.il/e...@itl.co.il  Web
<http://www.itlglobal.orh> www.itlglobal.orh

 

 <http://app.sqm.co.il/SitePages/Questionnaire.aspx> Fill out Customer
Satisfaction Survey

Global Certifications You Can Trust 

This e-mail message may contain privileged or confidential information. 

If you are not the intended recipient, you may not disclose, use,
disseminate, distribute, copy or rely upon this message or attachment in any
way. If you received this e-mail message in error, please return by
forwarding the message and its attachments to the sender.

 

 

-


This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
mailto:emc-p...@ieee.org> >

All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at
http://product-compliance.oc.ieee.org/ can be used for graphics (in
well-used formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to
unsubscribe) <http://www.ieee-pses.org/list.html> 
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org> >
Mike Cantwell mailto:mcantw...@ieee.org> > 

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org> >
David Heald mailto:dhe...@gmail.com> > 


-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2: 2014 Basic Safety and Essential Performance Pass/Fail Criteria

[Jim Bacher]

What do you mean by stopped working? Were you able to power it down, then
turn it back on to get the product back to normal operations?

I am not familiar with medical standards, however generally all ESD
standards expect a product to function normally during and after
testing. Without
knowing more details and from a generic standpoint, I would consider that
to be a failure .

Some standards will allow a product to be restarted to return to normal
operation and still consider it a pass.

I have crossed paths with a number of companies who contend regulations do
not apply to them, when the standards did apply to them. So when a company
tells me their product does not require safety certification I get nervous.
I usually tell them going through a safety certification is cheap
insurance. Then explain the cost of recalls and how a safety certification
can help prevent a recall.

Jim Bacher, JB Consulting
Product Regulatory Compliance Consultant
https://trc.guru/
IEEE Life Senior Member j.bac...@ieee.org


On Dec 28, 2017 1:48 AM, "itl-emc user group"  wrote:

Hello

A manufacturer of medical equipment has declared that his device has no
basic safety or essential requirements.

During ESD testing, the device stopped working after Air Discharges of ±15
kV were applied.

Is this regarded as a failure according to the standard?

No Part 2 particular Safety standards are involved.

Thanks in advance for any responses.

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] IEC 60601-1-2: 2014 Basic Safety and Essential Performance Pass/Fail Criteria

[itl-emc user group]

Hello
A manufacturer of medical equipment has declared that his device has no basic 
safety or essential requirements.
During ESD testing, the device stopped working after Air Discharges of ±15 kV 
were applied.
Is this regarded as a failure according to the standard?
No Part 2 particular Safety standards are involved.
Thanks in advance for any responses.


Regards,
David Shidlowsky | Technical Reviewer
Address 1 Bat-Sheva St. LOD 7120101 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail : 
dav...@itlglobal.org/dav...@itl.co.il/e...@itl.co.il
  Web www.itlglobal.orh

Fill out Customer Satisfaction 
Survey
Global Certifications You Can Trust
This e-mail message may contain privileged or confidential information.
If you are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.



-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] IEC 60601-1-2 Edition 4

[Steli Loznen]

Dear Colleagues,

 

Somebody can inform me if IEC 60601-1-2 Edition 4 is requested NOW in
Brazil. For EU and FDA the due date is 31 December 2018.

 

Thank in advance,

Steli

 

 

 

Steli Loznen, M.Sc., SM-IEEE

Member of BoD IEEE-PSES

Convener IEC 62A/MT 62354

17-3 Shaul HaMelech Blvd.

Tel Aviv 6436719

Israel

Tel:+972-3-6912668

Fax:+972-3-6913988

Mobile:+972-54-7245794

e-mail: sloz...@ieee.org

 


-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] 60601-1-2 Radiated Emission Measurement Distance per Japan PMDA and Korea MFDA

[Grace Lin]

Dear Members,

Is radiated emission test data taken at 3 meter measurement distance
accepted by Japan Pharmaceuticals and Medical Devices Agency (PMDA) and
Korea Ministry of Food and Drug Safety (MFDS)?

Thank you very much for your time and I look forward to hearing from you.

Best regards,
Grace Lin

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] 60601-1-2 edition 4 acceptance dates and DOW of edition 3

[Leo Eisner]

Hi Gary,

David Schaefer said on June 1, 2016, in this chain, the DOW (date of 
withdrawal) for the 3rd ed. of IEC 60601-1-2 is December 31st, 2018.  I am 
pretty sure that is the correct info.   

The knee is almost totally healed so working pretty normal hours now.  Thx for 
your note back in Mid June.

All the best,

 
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151 
Mobile: (503) 709-8328 
Email: l...@eisnersafety.com
Website: www.EisnerSafety.com 

*** Internet E-mail Confidentiality Disclaimer ***
This e-mail message may contain privileged or confidential information. If you 
are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.

Eisner Safety Consultants do not accept liability for any errors, omissions, 
corruption or virus in the contents of this message or any attachments that 
arise as a result of e-mail transmission.
***

> On Jun 17, 2016, at 1:33 PM, Leo Eisner  wrote:
> 
> Hi Gary,
> For the US I believe from memory it is April 1, 2017 so pretty soon.
> I have the EU info buried somewhere so when I get a chance (may be awhile as 
> I am only working couple hours per day max with being post knee surgery 1 
> week).
> Thx,
> 
> Leonard (Leo) Eisner, P.E.
> Principal Consultant, Eisner Safety Consultants
> Phone: (503) 244-6151
> Mobile: (503) 709-8328
> Email: l...@eisnersafety.com <mailto:l...@eisnersafety.com>
> Website: www.EisnerSafety.com <http://www.eisnersafety.com/>
>  
>  
> *** Internet E-mail Confidentiality Disclaimer ***
> This e-mail message may contain privileged or confidential information. If 
> you are not the intended recipient, you may not disclose, use, disseminate, 
> distribute, copy or rely upon this message or attachment in any way. If you 
> received this e-mail message in error, please return by forwarding the 
> message and its attachments to the sender.
> 
> Eisner Safety Consultants do not accept liability for any errors, omissions, 
> corruption or virus in the contents of this message or any attachments that 
> arise as a result of e-mail transmission.
> ***
> 
> On Jun 1, 2016, at 9:23 AM, Gary McInturff  <mailto:gary.mcintu...@esterline.com>> wrote:
> 
>> Are these dates still valid?
>> US and Canada requiring 4th edition in 2017?
>> EU accepting 4th edition but 3rd edition still acceptable for new products. 
>> What is the EU DOW. I tried hunting through the EU journal but could never 
>> find the standards dates. A link please?
>>  
>>  
>> In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical 
>> EMC. There are a number of changes in the 4th edition, including new 
>> immunity and risk analysis requirements.
>> Dates
>> For new products in the U.S., the FDA will make a decision on the 4th 
>> edition this July, with a likely 3-year transition period (2017 
>> recognition). The FDA does not currently require retesting of legacy 
>> products unless changes are made to the product that may affect its 
>> compliance.
>> Canada is planning to review the 4th Edition sometime in 2015 so it will not 
>> be accepted before 2015/2016. It’s typically 3 years before accepted 
>> standards are required for new submittals.
>> In Europe, CENELEC has voted affirmatively to accept the 4th edition but has 
>> not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 
>> 3rd Edition is expected in the 2017-2018 timeframe. There is no 
>> grandfathering in Europe.
>>  
>>  
>> Gary McInturff
>> Reliability/Compliance Engineer
>>  
>> Esterline Interface Technologies Featuring
>> ADVANCED INPUT, GAMESMAN, LRE MEDICAL, and MEMTRON  products   
>>  
>> 600 W. Wilbur AvenueCoeur d’Alene, ID  83815-9496
>> Toll Free: 800-444-5923
>> Tel:  (208) 635-8306
>>  
>> www.esterline.com/interfacetechnologies 
>> <http://www.esterline.com/interfacetechnologies>
>>  
>> Technology, Innovation, Performance…
>> "Information in or attached to this e-mail message may be subject to export 
>> control restrictions of the International Traffic in Arms Regulations (ITAR) 
>> (22 CFR pts. 120-130) or the Export Administration Regulations (EAR) (15 CFR 
>> pts. 730-774).  Before exporting this informa

Re: [PSES] 60601-1-2 edition 4 acceptance dates and DOW of edition 3

[Leo Eisner]

Hi Gary,
For the US I believe from memory it is April 1, 2017 so pretty soon.
I have the EU info buried somewhere so when I get a chance (may be awhile as I 
am only working couple hours per day max with being post knee surgery 1 week).
Thx,

Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: l...@eisnersafety.com
Website: www.EisnerSafety.com
 
 
*** Internet E-mail Confidentiality Disclaimer ***
This e-mail message may contain privileged or confidential information. If you 
are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.

Eisner Safety Consultants do not accept liability for any errors, omissions, 
corruption or virus in the contents of this message or any attachments that 
arise as a result of e-mail transmission.
***

On Jun 1, 2016, at 9:23 AM, Gary McInturff  wrote:

> Are these dates still valid?
> US and Canada requiring 4th edition in 2017?
> EU accepting 4th edition but 3rd edition still acceptable for new products. 
> What is the EU DOW. I tried hunting through the EU journal but could never 
> find the standards dates. A link please?
>  
>  
> In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical 
> EMC. There are a number of changes in the 4th edition, including new immunity 
> and risk analysis requirements.
> Dates
> For new products in the U.S., the FDA will make a decision on the 4th edition 
> this July, with a likely 3-year transition period (2017 recognition). The FDA 
> does not currently require retesting of legacy products unless changes are 
> made to the product that may affect its compliance.
> Canada is planning to review the 4th Edition sometime in 2015 so it will not 
> be accepted before 2015/2016. It’s typically 3 years before accepted 
> standards are required for new submittals.
> In Europe, CENELEC has voted affirmatively to accept the 4th edition but has 
> not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 
> 3rd Edition is expected in the 2017-2018 timeframe. There is no 
> grandfathering in Europe.
>  
>  
> Gary McInturff
> Reliability/Compliance Engineer
>  
> Esterline Interface Technologies  Featuring
> ADVANCED INPUT, GAMESMAN, LRE MEDICAL, and MEMTRON  products   
>  
> 600 W. Wilbur AvenueCoeur d’Alene, ID  83815-9496
> Toll Free: 800-444-5923
> Tel:  (208) 635-8306
>  
> www.esterline.com/interfacetechnologies
>  
> Technology, Innovation, Performance…
> "Information in or attached to this e-mail message may be subject to export 
> control restrictions of the International Traffic in Arms Regulations (ITAR) 
> (22 CFR pts. 120-130) or the Export Administration Regulations (EAR) (15 CFR 
> pts. 730-774).  Before exporting this information outside the United States 
> or releasing it to a foreign person in the United States, you need to 
> determine whether a license under the EAR or the ITAR is required to do so.  
> If you have any questions about this obligation, please contact me."
>  
> Click here to read disclaimer
>
>  
>  
>  
>  
>  
> -
> 
> This message is from the IEEE Product Safety Engineering Society emc-pstc 
> discussion list. To post a message to the list, send your e-mail to 
> 
> 
> All emc-pstc postings are archived and searchable on the web at: 
> http://www.ieee-pses.org/emc-pstc.html
> 
> Attachments are not permitted but the IEEE PSES Online Communities site at 
> http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
> formats), large files, etc.
> 
> Website: http://www.ieee-pses.org/
> Instructions: http://www.ieee-pses.org/list.html (including how to 
> unsubscribe)
> List rules: http://www.ieee-pses.org/listrules.html
> 
> For help, send mail to the list administrators:
> Scott Douglas 
> Mike Cantwell 
> 
> For policy questions, send mail to:
> Jim Bacher 
> David Heald 
> 


-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats)

Re: [PSES] 60601-1-2 edition 4 acceptance dates and DOW of edition 3

[Schaefer, David]

Gary,

Were you looking in the EMC OJ, or MDD OJ? There was a new MDD OJ in mid May. 
Per this link: 
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=uriserv:OJ.C_.2016.173.01.0100.01.ENG

December 31st, 2018 is the DOW.

Thanks,

David



From: Gary McInturff [mailto:gary.mcintu...@esterline.com]
Sent: Wednesday, June 01, 2016 11:23 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] 60601-1-2 edition 4 acceptance dates and DOW of edition 3

Are these dates still valid?
US and Canada requiring 4th edition in 2017?
EU accepting 4th edition but 3rd edition still acceptable for new products. 
What is the EU DOW. I tried hunting through the EU journal but could never find 
the standards dates. A link please?


In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. 
There are a number of changes in the 4th edition, including new immunity and 
risk analysis requirements.
Dates
For new products in the U.S., the FDA will make a decision on the 4th edition 
this July, with a likely 3-year transition period (2017 recognition). The FDA 
does not currently require retesting of legacy products unless changes are made 
to the product that may affect its compliance.
Canada is planning to review the 4th Edition sometime in 2015 so it will not be 
accepted before 2015/2016. It's typically 3 years before accepted standards are 
required for new submittals.
In Europe, CENELEC has voted affirmatively to accept the 4th edition but has 
not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 3rd 
Edition is expected in the 2017-2018 timeframe. There is no grandfathering in 
Europe.


Gary McInturff
Reliability/Compliance Engineer





Esterline Interface Technologies

Featuring
ADVANCED INPUT, GAMESMAN, LRE MEDICAL, and MEMTRON  products


600 W. Wilbur AvenueCoeur d'Alene, ID  83815-9496
Toll Free: 800-444-5923
Tel:  (208) 635-8306

www.esterline.com/interfacetechnologies<http://www.esterline.com/interfacetechnologies>

Technology, Innovation, Performance...
"Information in or attached to this e-mail message may be subject to export 
control restrictions of the International Traffic in Arms Regulations (ITAR) 
(22 CFR pts. 120-130) or the Export Administration Regulations (EAR) (15 CFR 
pts. 730-774).  Before exporting this information outside the United States or 
releasing it to a foreign person in the United States, you need to determine 
whether a license under the EAR or the ITAR is required to do so.  If you have 
any questions about this obligation, please contact me."

Click 
here<http://www.esterline.com/governance/email_disclaimer/tabid/1532/Default.aspx>
 to read disclaimer








-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)<http://www.ieee-pses.org/list.html>
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] 60601-1-2 edition 4 acceptance dates and DOW of edition 3

[Gary McInturff]

Are these dates still valid?
US and Canada requiring 4th edition in 2017?
EU accepting 4th edition but 3rd edition still acceptable for new products. 
What is the EU DOW. I tried hunting through the EU journal but could never find 
the standards dates. A link please?


In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. 
There are a number of changes in the 4th edition, including new immunity and 
risk analysis requirements.
Dates
For new products in the U.S., the FDA will make a decision on the 4th edition 
this July, with a likely 3-year transition period (2017 recognition). The FDA 
does not currently require retesting of legacy products unless changes are made 
to the product that may affect its compliance.
Canada is planning to review the 4th Edition sometime in 2015 so it will not be 
accepted before 2015/2016. It's typically 3 years before accepted standards are 
required for new submittals.
In Europe, CENELEC has voted affirmatively to accept the 4th edition but has 
not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 3rd 
Edition is expected in the 2017-2018 timeframe. There is no grandfathering in 
Europe.


Gary McInturff
Reliability/Compliance Engineer



Esterline Interface Technologies
Featuring
ADVANCED INPUT, GAMESMAN, LRE MEDICAL, and MEMTRON  products


600 W. Wilbur AvenueCoeur d'Alene, ID  83815-9496
Toll Free: 800-444-5923
Tel:  (208) 635-8306

www.esterline.com/interfacetechnologies<http://www.esterline.com/interfacetechnologies>

Technology, Innovation, Performance...
"Information in or attached to this e-mail message may be subject to export 
control restrictions of the International Traffic in Arms Regulations (ITAR) 
(22 CFR pts. 120-130) or the Export Administration Regulations (EAR) (15 CFR 
pts. 730-774).  Before exporting this information outside the United States or 
releasing it to a foreign person in the United States, you need to determine 
whether a license under the EAR or the ITAR is required to do so.  If you have 
any questions about this obligation, please contact me."

Click 
here<http://www.esterline.com/governance/email_disclaimer/tabid/1532/Default.aspx>
 to read disclaimer








-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC-60601-1-2: 2014 (4th Edition)

[T.Sato]

On Mon, 23 May 2016 05:22:07 +,
  itl-emc user group  wrote:

> According to Clause 5.2.2.1 "Requirements applicable to all ME EQUIPMENT and 
> ME SYSTEMS", :
> "For all ME EQUIPMENT and ME SYSTEMS, the technical description shall include 
> the following information:
> a) the compliance for each EMISSIONS and IMMUNITY standard or test specified 
> by this collateral standard, e.g. EMISSIONS class and group and IMMUNITY TEST 
> LEVEL;
> b) any deviations from this collateral standard and allowances used;
> c) * all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL 
> PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES for the EXPECTED 
> SERVICE LIFE."
> In IEC 60601-1-2: 2007, the above information was provided in the Guidance 
> and MANUFACTURER'S declaration - ELECTROMAGNETIC EMISSIONS tables.
> I did not find any similar tables in IEC 60601-1-2: 2014 .
> Any ideas on how to instruct clients to comply with Clause 5.2.2.1 a, b, c?

IEC 60601-1-2:2014 Annex A has some additional guide:

  Subclause 5.2.2.1 a), Compliance for each EMISSIONS and IMMUNITY
  standard

  This requirement replaces in part the requirements specified in
  Edition 3 to include tables of compliance levels and EMC guidance in
  the ACCOMPANYING DOCUMENTS. While a MANUFACTURER can choose to put
  the information in such a format, this collateral standard does not
  mandate the format for this information. ...

Regards,
Tom

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] IEC-60601-1-2: 2014 (4th Edition)

[itl-emc user group]

Hello,
According to Clause 5.2.2.1 "Requirements applicable to all ME EQUIPMENT and ME 
SYSTEMS", :
"For all ME EQUIPMENT and ME SYSTEMS, the technical description shall include 
the following information:
a) the compliance for each EMISSIONS and IMMUNITY standard or test specified by 
this collateral standard, e.g. EMISSIONS class and group and IMMUNITY TEST 
LEVEL;
b) any deviations from this collateral standard and allowances used;
c) * all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL 
PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES for the EXPECTED 
SERVICE LIFE."
In IEC 60601-1-2: 2007, the above information was provided in the Guidance and 
MANUFACTURER'S declaration - ELECTROMAGNETIC EMISSIONS tables.
I did not find any similar tables in IEC 60601-1-2: 2014 .
Any ideas on how to instruct clients to comply with Clause 5.2.2.1 a, b, c?
Thanks in advance for any responses

Regards,
David Shidlowsky | Technical Reviewer
Address 1 Bat-Sheva St. LOD 7120101 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail dav...@itl.co.il<mailto:dav...@itl.co.il>/e...@itl.co.il  Web 
www.itl.co.il<http://www.itl.co.il/>

Fill out Customer Satisfaction 
Survey<http://app.sqm.co.il/SitePages/Questionnaire.aspx>
Global Certifications You Can Trust
This e-mail message may contain privileged or confidential information.
If you are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.






-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2: 2014 ; Radio Equipment Directive Harmonised Standards

[Charlie Blackham]

>Does anyone have any idea as to when a list of harmonized standards will be 
>published for the RED?



No time soon I would think - there are a large number of radio standards that 
need to be revised and ETSI is still working on its guidance document as to how 
to apply EMC to radio and non-radio functionality within a product.



Existing legislation for products that fall under RED (R&TTE or EMC/LVD) may 
continue to be used until 13 June 2017 so there's no immediate concern



regards

Charlie

Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317[X]
Web: 
www.sulisconsultants.com<https://outlook.hslive.net/owa/redir.aspx?C=02be3bf3e3a544d1bdf7b6c99fbd12f5&URL=http%3a%2f%2fwww.sulisconsultants.com%2f>
Registered in England and Wales, number 05466247

From: itl-emc user group 
Sent: 04 February 2016 05:26
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] IEC 60601-1-2: 2014 ; Radio Equipment Directive Harmonised 
Standards

Hi,
I have just looked at the list of EU Harmonised Standards web site and was 
wondering:
Does anyone have any idea as to when a list of harmonized standards will be 
published for the RED?
Does anyone have any idea as to when IEC 60601-1-2: 2014 will be adopted as an 
EN standard. The latest MDD list of harmonised standards was published on 10 
July 2015.
Thanks in advance for any responses.

Regards,
David Shidlowsky | Technical Reviewer
Address 1 Bat-Sheva St. POB 87, LOD 71100 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail dav...@itl.co.il<mailto:dav...@itl.co.il>/e...@itl.co.il  Web 
www.itl.co.il<http://www.itl.co.il/>

Fill out Customer Satisfaction 
Survey<http://app.sqm.co.il/SitePages/Questionnaire.aspx>
Global Certifications You Can Trust
This e-mail message may contain privileged or confidential information.
If you are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.




-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)<http://www.ieee-pses.org/list.html>
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] IEC 60601-1-2: 2014 ; Radio Equipment Directive Harmonised Standards

[itl-emc user group]

Hi,
I have just looked at the list of EU Harmonised Standards web site and was 
wondering:
Does anyone have any idea as to when a list of harmonized standards will be 
published for the RED?
Does anyone have any idea as to when IEC 60601-1-2: 2014 will be adopted as an 
EN standard. The latest MDD list of harmonised standards was published on 10 
July 2015.
Thanks in advance for any responses.

Regards,
David Shidlowsky | Technical Reviewer
Address 1 Bat-Sheva St. POB 87, LOD 71100 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail dav...@itl.co.il<mailto:dav...@itl.co.il>/e...@itl.co.il  Web 
www.itl.co.il<http://www.itl.co.il/>

Fill out Customer Satisfaction 
Survey<http://app.sqm.co.il/SitePages/Questionnaire.aspx>
Global Certifications You Can Trust
This e-mail message may contain privileged or confidential information.
If you are not the intended recipient, you may not disclose, use, disseminate, 
distribute, copy or rely upon this message or attachment in any way. If you 
received this e-mail message in error, please return by forwarding the message 
and its attachments to the sender.





-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

[Patrick]

Marina -
A new version of the standard is in process of being adopted, and this test
is one of the areas that is evolving.

Regarding power frequency magnetic fields:

1-The IEC 60601-1-2 {Edition 3} has no exceptions that I can find.

2-However, IEC 60601-1-2 {Edition 4} includes a note regarding power
frequency magnetic fields.
Table 4 of the {Edition 4} includes this note:
"d) Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive
components or circuitry."


Based on the above info, if a medical product is testing and declaring to
{Edition 4} then this exclusion is available.  Otherwise, the test is
required.

Hope this helps.
-Patrick

On Mon, Nov 30, 2015 at 1:27 PM, MARINA PEYZNER 
wrote:

> Dear members.
>
> Does anybody can point me out the mandatory of request for Power Frequency
> Magnetic Field testing for medical equipment even if none magnetic
> sensitive elements are in the EUT ?
>
> If this test is a must regardless of existence or not these elements.
>
> Thanks,
> Eugene
>
>
> -
> 
>
> This message is from the IEEE Product Safety Engineering Society emc-pstc
> discussion list. To post a message to the list, send your e-mail to <
> emc-p...@ieee.org>
>
> All emc-pstc postings are archived and searchable on the web at:
> http://www.ieee-pses.org/emc-pstc.html
>
> Attachments are not permitted but the IEEE PSES Online Communities site at
> http://product-compliance.oc.ieee.org/ can be used for graphics (in
> well-used formats), large files, etc.
>
> Website: http://www.ieee-pses.org/
> Instructions: http://www.ieee-pses.org/list.html (including how to
> unsubscribe) <http://www.ieee-pses.org/list.html>
> List rules: http://www.ieee-pses.org/listrules.html
>
> For help, send mail to the list administrators:
> Scott Douglas <sdoug...@ieee.org>
> Mike Cantwell <mcantw...@ieee.org>
>
> For policy questions, send mail to:
> Jim Bacher <j.bac...@ieee.org>
> David Heald <dhe...@gmail.com>
>



-- 
//
Patrick

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

[Brian O'Connell]

IEC60601-1-2 points to the IEC61000-4-X and -6 stuff for immunity, and 
IEC60601-1-11 extends EMC stuff for home healthcare equipment. The latest 
edition of -1-2 has some interesting stuff about test levels in annex E, and 
all medical EMC is based on intended end-use environment with no allowance for 
construction. Otherwise, you need to write a very pretty engineering rationale 
to satisfy risk manglement (management?) requirements.

Also, the test lab needs to specifically state why tests not done and provide a 
'judgment' statement.

Brian


From: MARINA PEYZNER [mailto:epeyz...@sbcglobal.net] 
Sent: Monday, November 30, 2015 12:27 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

Dear members.

Does anybody can point me out the mandatory of request for Power Frequency 
Magnetic Field testing for medical equipment even if none magnetic sensitive 
elements are in the EUT ? 

If this test is a must regardless of existence or not these elements.

Thanks,
Eugene

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

[Nyffenegger, Dave]

I have received EMC directive test reports (non-medical equipment) from our 
NRTLs in  the past stating this as well, that magnetic field testing was not 
done as there were no magnetic sensitive elements.

-Dave

From: Kunde, Brian [mailto:brian_ku...@lecotc.com]
Sent: Monday, November 30, 2015 4:01 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

Eugene,

The EMC Directive requires the manufacturer performs a “Conformity Assessment”, 
sometimes referred to as an “EMC Compatibility Assessment”.  Within this 
assessment, the manufacturer can explain the reasons for and against which EMC 
tests and test levels they tested their products to to show compliance to the 
Directive.

So in this document, you simply explain why the 4-8 test is unnecessary to be 
performed. It’s as simple as that. Of course, if you are wrong in your 
assessment, you are responsible to take corrective measures.

The Other Brian


From: MARINA PEYZNER [mailto:epeyz...@sbcglobal.net]
Sent: Monday, November 30, 2015 3:27 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

Dear members.

Does anybody can point me out the mandatory of request for Power Frequency 
Magnetic Field testing for medical equipment even if none magnetic sensitive 
elements are in the EUT ?

If this test is a must regardless of existence or not these elements.

Thanks,
Eugene


-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)<http://www.ieee-pses.org/list.html>
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>


LECO Corporation Notice: This communication may contain confidential 
information intended for the named recipient(s) only. If you received this by 
mistake, please destroy it and notify us of the error. Thank you.
-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)<http://www.ieee-pses.org/list.html>
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

[Kunde, Brian]

Eugene,

The EMC Directive requires the manufacturer performs a “Conformity Assessment”, 
sometimes referred to as an “EMC Compatibility Assessment”.  Within this 
assessment, the manufacturer can explain the reasons for and against which EMC 
tests and test levels they tested their products to to show compliance to the 
Directive.

So in this document, you simply explain why the 4-8 test is unnecessary to be 
performed. It’s as simple as that. Of course, if you are wrong in your 
assessment, you are responsible to take corrective measures.

The Other Brian


From: MARINA PEYZNER [mailto:epeyz...@sbcglobal.net]
Sent: Monday, November 30, 2015 3:27 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

Dear members.

Does anybody can point me out the mandatory of request for Power Frequency 
Magnetic Field testing for medical equipment even if none magnetic sensitive 
elements are in the EUT ?

If this test is a must regardless of existence or not these elements.

Thanks,
Eugene


-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)<http://www.ieee-pses.org/list.html>
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:sdoug...@ieee.org>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>


LECO Corporation Notice: This communication may contain confidential 
information intended for the named recipient(s) only. If you received this by 
mistake, please destroy it and notify us of the error. Thank you.

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] EN 61000-4-8 test for medical equipment per EN 60601-1-2

[MARINA PEYZNER]

Dear members.
Does anybody can point me out the mandatory of request for Power Frequency 
Magnetic Field testing for medical equipment even if none magnetic sensitive 
elements are in the EUT ? 

If this test is a must regardless of existence or not these elements.
Thanks,Eugene



-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] Testing to EN/IEC 60601-1-2

[Wiseman, Joshua E BIS]

David,

Some safety labs will rely on the EMC test house to verify the applicable 
Clause 5 requirements from an EMC aspect.  This was something I saw at times 
when I was working at an NRTL.

Josh

From: itl-emc user group [mailto:itl...@itl.co.il]
Sent: Tuesday, March 04, 2014 11:36 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [External] [PSES] Testing to EN/IEC 60601-1-2

Hello,
Looking for opinions concerning testing to EN/IEC 60601-1-2.
Some customers want to perform partial testing only and for CE declare that 
their device meets the requirements of EN/IEC 60601-1-2.
As a test lab, we recommend full testing.
Any opinions.
Also some of our customers insist that Clause 5 Identification, marking and 
documents, should be part of the test report. Any opinions concerning this.
All responses welcome.

Regards,
David Shidlowsky | Technical Writer
Address 1 Bat-Sheva St. POB 87, LOD 71100 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail e...@itl.co.il/dav...@itl.co.il<mailto:e...@itl.co.il/dav...@itl.co.il>  
Web www.itl.co.il<http://www.itl.co.il/>

Fill out Customer Satisfaction 
Survey<http://app.sqm.co.il/SitePages/Questionnaire.aspx>
Global Certifications You Can Trust

-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)<http://www.ieee-pses.org/list.html>
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:emcp...@radiusnorth.net>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] Testing to EN/IEC 60601-1-2

[Charlie Blackham]

David

Personally, I ask ( and expect) test labs to test whatever they're asked to 
test, but I ask them to do so against a specific test plan.

Your client may well have good reason for partial testing...or they might 
be trying to do the base minimum they think they can get away with. If it's the 
former then they should have produced an EMC test plan / justification document 
as to why partial testing is all they need to do.

By asking them for a test plan, or summary table from their Justification 
document, you can they perform the requested tests, in an accredited manner, 
and issue a report stating results against the document. It is then clear why 
you only performed certain tests.

Regards
Charlie


From: itl-emc user group [mailto:itl...@itl.co.il]
Sent: 05 March 2014 05:36
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Testing to EN/IEC 60601-1-2

Hello,
Looking for opinions concerning testing to EN/IEC 60601-1-2.
Some customers want to perform partial testing only and for CE declare that 
their device meets the requirements of EN/IEC 60601-1-2.
As a test lab, we recommend full testing.
Any opinions.
Also some of our customers insist that Clause 5 Identification, marking and 
documents, should be part of the test report. Any opinions concerning this.
All responses welcome.

Regards,
David Shidlowsky | Technical Writer
Address 1 Bat-Sheva St. POB 87, LOD 71100 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail e...@itl.co.il/dav...@itl.co.il<mailto:e...@itl.co.il/dav...@itl.co.il>  
Web www.itl.co.il<http://www.itl.co.il/>

Fill out Customer Satisfaction 
Survey<http://app.sqm.co.il/SitePages/Questionnaire.aspx>
Global Certifications You Can Trust

-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://www.ieee-pses.org/list.html (including how to 
unsubscribe)<http://www.ieee-pses.org/list.html>
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:emcp...@radiusnorth.net>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] Testing to EN/IEC 60601-1-2

[itl-emc user group]

Hello,
Looking for opinions concerning testing to EN/IEC 60601-1-2.
Some customers want to perform partial testing only and for CE declare that 
their device meets the requirements of EN/IEC 60601-1-2.
As a test lab, we recommend full testing.
Any opinions.
Also some of our customers insist that Clause 5 Identification, marking and 
documents, should be part of the test report. Any opinions concerning this.
All responses welcome.

Regards,
David Shidlowsky | Technical Writer
Address 1 Bat-Sheva St. POB 87, LOD 71100 Israel
Tel 972-8-9186113 Fax 972-8-9153101
Mail e...@itl.co.il/dav...@itl.co.il<mailto:e...@itl.co.il/dav...@itl.co.il>  
Web www.itl.co.il<http://www.itl.co.il/>

Fill out Customer Satisfaction 
Survey<http://app.sqm.co.il/SitePages/Questionnaire.aspx>
Global Certifications You Can Trust


-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2 autoranging supplies

[John Woodgate]

In message <1354551670.87252.yahoomail...@web160604.mail.bf1.yahoo.com>, 
dated Mon, 3 Dec 2012, David  writes:


IEC 60601-1-2 requires surge, burst, and dropouts be done at the 
maximum and minimum rated voltages for autoranging supplies.  We 
typically test at 90 Vac and 240 Vac.  Many supplies I see now are 
rated up to 264 Vac though.  Is anyone testing at 264V?  Are there 
variacs out there to bump the input voltage, since our generator can't 
go much above 240?


I doubt that 264 V is a 'rated voltage' - it is the upper limit of 240 V 
supplies with a +10% allowance. Any product claimed to have a rated 
voltage of 264 V would need to remain safe with 290.4 V input.

--
OOO - Own Opinions Only. See www.jmwa.demon.co.uk
The longer it takes to make a point, the more obtuse it proves to be.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

This message is from the IEEE Product Safety Engineering Society emc-pstc discussion 
list. To post a message to the list, send your e-mail to 

All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2 autoranging supplies

[Kunde, Brian]

David,

The rating verses test voltage falls under the chicken and egg scenario 
sometimes especially for power supplies. If a product is rated 240V some 
testing is required at +10% which is 264V. Some power supply companies rate 
their products up to 264V so their customers know it will handle it, but then 
again, some safety labs will insist on performing some tests at 264V +10% more. 
You cannot win.

We perform some tests on our  products at 264Vac. We use a double decker 
PowerStat Autotransformer from Superior Electronics rated 70amps max (35 amps 
per deck). I'm sure there are many others on the market.

We used to use our programmable power supply but the surge test kept taking out 
the surge suppressor varistors on the front end. The repair bill got a bit 
large before we realized what was happening.

The Other Brian

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of David
Sent: Monday, December 03, 2012 11:21 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: IEC 60601-1-2 autoranging supplies

All,

IEC 60601-1-2 requires surge, burst, and dropouts be done at the maximum and 
minimum rated voltages for autoranging supplies.  We typically test at 90 Vac 
and 240 Vac.  Many supplies I see now are rated up to 264 Vac though.  Is 
anyone testing at 264V?  Are there variacs out there to bump the input voltage, 
since our generator can't go much above 240?

Thanks,

David
-


This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 
mailto:emc-p...@ieee.org>>

All emc-pstc postings are archived and searchable on the web at: 
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas mailto:emcp...@radiusnorth.net>>
Mike Cantwell mailto:mcantw...@ieee.org>>

For policy questions, send mail to:
Jim Bacher mailto:j.bac...@ieee.org>>
David Heald mailto:dhe...@gmail.com>>


LECO Corporation Notice: This communication may contain confidential 
information intended for the named recipient(s) only. If you received this by 
mistake, please destroy it and notify us of the error. Thank you.

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2 autoranging supplies

[Brian Oconnell]

The operating/instruction manual is part of the safety submittal/approval
process and shall have correct ratings per the Type Test conditions. But
sales-infected spec sheets on websites or on advertising brochures are not
worthy of notice. Common problem in power industry.

If label and manual have different ratings - then the supplier's compliance
guy should be directly interrogated.

Brian

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of
ralph.mcdiar...@schneider-electric.com
Sent: Monday, December 03, 2012 10:36 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] IEC 60601-1-2 autoranging supplies

It certainly depends on how you rate the product, and what "ratings" really
means.  Typically the voltage rating would be marked on the nameplate of the
product, but some agencies will go look in the often embellished
specifications in the operator manual for the voltage range.

Some auto-ranging power supplies mark the a.c. input as a list of nominal
voltages, as in "100/120/220/240V".

___

Ralph McDiarmid  |   Schneider Electric   |  Solar Business  |   CANADA  |
Regulatory Compliance Engineering



From: Brian Oconnell 
To: EMC-PSTC@LISTSERV.IEEE.ORG,
Date: 12/03/2012 08:55 AM
Subject: Re: [PSES] IEC 60601-1-2 autoranging supplies

Rated by test certificate and CB report, or by the sales dept-infected spec
sheet?

That is, what is the rating on the unit's label?

You can configure most variacs to provide well above the input voltage, but
this may do strange stuff to the source impendence. Use a really really
really big variac, or use an electronic source (Ametek, Chroma, etc).

Brian

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of David
Sent: Monday, December 03, 2012 8:21 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: IEC 60601-1-2 autoranging supplies

All,

IEC 60601-1-2 requires surge, burst, and dropouts be done at the maximum and
minimum rated voltages for autoranging supplies.  We typically test at 90
Vac and 240 Vac.  Many supplies I see now are rated up to 264 Vac though.
Is anyone testing at 264V?  Are there variacs out there to bump the input
voltage, since our generator can't go much above 240?

Thanks,

David

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2 autoranging supplies

[Ralph . McDiarmid]

It certainly depends on how you rate the product, and what "ratings" 
really means.  Typically the voltage rating would be marked on the 
nameplate of the product, but some agencies will go look in the often 
embellished specifications in the operator manual for the voltage range. 

Some auto-ranging power supplies mark the a.c. input as a list of nominal 
voltages, as in "100/120/220/240V". 
___ 


Ralph McDiarmid  |   Schneider Electric   |  Solar Business  |   CANADA  | 
  Regulatory Compliance Engineering 




From:
Brian Oconnell 
To:
EMC-PSTC@LISTSERV.IEEE.ORG, 
Date:
12/03/2012 08:55 AM
Subject:
Re: [PSES] IEC 60601-1-2 autoranging supplies



Rated by test certificate and CB report, or by the sales dept-infected 
spec
sheet?

That is, what is the rating on the unit's label?

You can configure most variacs to provide well above the input voltage, 
but
this may do strange stuff to the source impendence. Use a really really
really big variac, or use an electronic source (Ametek, Chroma, etc).

Brian

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of David
Sent: Monday, December 03, 2012 8:21 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: IEC 60601-1-2 autoranging supplies

All,

IEC 60601-1-2 requires surge, burst, and dropouts be done at the maximum 
and
minimum rated voltages for autoranging supplies.  We typically test at 90
Vac and 240 Vac.  Many supplies I see now are rated up to 264 Vac though.
Is anyone testing at 264V?  Are there variacs out there to bump the input
voltage, since our generator can't go much above 240?

Thanks,

David

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in 
well-used formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

__
This email has been scanned by the Symantec Email Security.cloud service.
__



-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

Re: [PSES] IEC 60601-1-2 autoranging supplies

[Brian Oconnell]

Rated by test certificate and CB report, or by the sales dept-infected spec
sheet?

That is, what is the rating on the unit's label?

You can configure most variacs to provide well above the input voltage, but
this may do strange stuff to the source impendence. Use a really really
really big variac, or use an electronic source (Ametek, Chroma, etc).

Brian

-Original Message-
From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of David
Sent: Monday, December 03, 2012 8:21 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: IEC 60601-1-2 autoranging supplies

All,

IEC 60601-1-2 requires surge, burst, and dropouts be done at the maximum and
minimum rated voltages for autoranging supplies.  We typically test at 90
Vac and 240 Vac.  Many supplies I see now are rated up to 264 Vac though.
Is anyone testing at 264V?  Are there variacs out there to bump the input
voltage, since our generator can't go much above 240?

Thanks,

David

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

[PSES] IEC 60601-1-2 autoranging supplies

[David]

All,
 
IEC 60601-1-2 requires surge, burst, and dropouts be done at the maximum and 
minimum rated voltages for autoranging supplies.  We typically test at 90 Vac 
and 240 Vac.  Many supplies I see now are rated up to 264 Vac though.  Is 
anyone testing at 264V?  Are there variacs out there to bump the input voltage, 
since our generator can't go much above 240?
 
Thanks,
 
David

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

RE: [PSES] EN 60601-1-2 50Hz or 60Hz

[emc-p...@ieee.org]

Depending on your test facilities process finding the worse case
voltage/frequency can be more painful than it need be, but typically I’ve
run equipment rotation through 4 different heights with the analyzer on max
hold, changed input and did it again. So we’re looking at an hour maybe
extra to define worse case. This is for emissions only, the conducted stuff
still has to be run at both settings, but unless changing input is a long
drawn out process its pretty painless.

 

Gary McInturff

208 635 8306

 



From: Andy Clifford [mailto:andy.cliff...@conformance.co.uk] 
Sent: Friday, July 16, 2010 8:52 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] EN 60601-1-2 50Hz or 60Hz

 

Recent interpretation at IEC level (62A/685 – approved) has made it clear
that testing at one frequency and power (worst case) is sufficient. I would
expect that the FDA would accept this.

 

Best regards
Andy

Andy Clifford
 Conformance Ltd - Product safety, approvals and CE-marking consultants, The
Old Methodist Chapel, Great Hucklow, Buxton, SK17 8RG England Tel. +44 1298
873800, Fax. +44 1298 873801, www.conformance.co.uk Registered in England,
Company No. 3478646



From: Andrew Robbins [mailto:andrew.robb...@nemko.com] 
Sent: 16 July 2010 16:02
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] EN 60601-1-2 50Hz or 60Hz

 

Friends and colleagues:

 

Customer needs to perform EMC testing (EN 60601-1-2:2007) on a large medical
device that is rated to operate 240VAC/60Hz or 220VAC/50Hz.  They intend to
use the reports to support an FDA submittal for sales in the US and CE marking
for sales in the EU.  Is it typical that the testing is performed twice, once
with power input at 240/60 and again at 220/50?

 

Andrew Robbins


This message contains information that may be privileged or 
confidential and is the property of the Nemko Group.
It is intended only for the person to whom it is addressed. 
If you are not the intended recipient, you are not authorized to read,
print, retain, copy, disseminate, distribute, or use this message or 
any part thereof. If you receive this message in error, please notify
the sender immediately and delete all copies of this message.
Nemko Group can not be held responsible for transmission errors nor
confidentiality of mail and faxes.

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell  

For policy questions, send mail to:
Jim Bacher 
David Heald  

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell  

For policy questions, send mail to:
Jim Bacher 
David Heald  

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell  

For policy questions, send mail to:
Jim Bacher 
David Heald  

Re: [PSES] EN 60601-1-2 50Hz or 60Hz

[emc-p...@ieee.org]

In message <3DDC15114B2A4088991CD90168E68954@ANDYTHINKPAD>, dated Fri, 
16 Jul 2010, Andy Clifford  writes:

>Recent interpretation at IEC level (62A/685 ? approved) has made it 
>clear that testing at one frequency and power (worst case) is 
>sufficient. I would expect that the FDA would accept this.

It's an Interpretation Sheet, not an amendment or corrigendum. It is 
essential to check what the FDA think of it.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
I should be disillusioned, but it's not worth the effort.
But I support unbloated email http://www.asciiribbon.org/

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

RE: [PSES] EN 60601-1-2 50Hz or 60Hz

[emc-p...@ieee.org]

Recent interpretation at IEC level (62A/685 – approved) has made it clear
that testing at one frequency and power (worst case) is sufficient. I would
expect that the FDA would accept this.

 

Best regards
Andy

Andy Clifford
 Conformance Ltd - Product safety, approvals and CE-marking consultants, The
Old Methodist Chapel, Great Hucklow, Buxton, SK17 8RG England Tel. +44 1298
873800, Fax. +44 1298 873801, www.conformance.co.uk Registered in England,
Company No. 3478646





From: Andrew Robbins [mailto:andrew.robb...@nemko.com] 
Sent: 16 July 2010 16:02
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] EN 60601-1-2 50Hz or 60Hz

 

Friends and colleagues:

 

Customer needs to perform EMC testing (EN 60601-1-2:2007) on a large medical
device that is rated to operate 240VAC/60Hz or 220VAC/50Hz.  They intend to
use the reports to support an FDA submittal for sales in the US and CE marking
for sales in the EU.  Is it typical that the testing is performed twice, once
with power input at 240/60 and again at 220/50?

 

Andrew Robbins


This message contains information that may be privileged or 
confidential and is the property of the Nemko Group.
It is intended only for the person to whom it is addressed. 
If you are not the intended recipient, you are not authorized to read,
print, retain, copy, disseminate, distribute, or use this message or 
any part thereof. If you receive this message in error, please notify
the sender immediately and delete all copies of this message.
Nemko Group can not be held responsible for transmission errors nor
confidentiality of mail and faxes.

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell  

For policy questions, send mail to:
Jim Bacher 
David Heald  

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 

Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell  

For policy questions, send mail to:
Jim Bacher 
David Heald  

RE: EN 60601-1-2 50Hz or 60Hz

[emc-p...@ieee.org]

I think the 60601-1-2 TC Interpretation Sheet (IS 01 60601-1-2) in the
following link may answer your question:
http://www.iecee.org/ctl/TC_interpretation.htm#60601
 
Nick



From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Andrew Robbins
Sent: Friday, July 16, 2010 10:02 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: EN 60601-1-2 50Hz or 60Hz


Friends and colleagues:
 
Customer needs to perform EMC testing (EN 60601-1-2:2007) on a large medical
device that is rated to operate 240VAC/60Hz or 220VAC/50Hz.  They intend to
use the reports to support an FDA submittal for sales in the US and CE marking
for sales in the EU.  Is it typical that the testing is performed twice, once
with power input at 240/60 and again at 220/50?
 
Andrew Robbins

This message contains information that may be privileged or 
confidential and is the property of the Nemko Group.
It is intended only for the person to whom it is addressed. 
If you are not the intended recipient, you are not authorized to read,
print, retain, copy, disseminate, distribute, or use this message or 
any part thereof. If you receive this message in error, please notify
the sender immediately and delete all copies of this message.
Nemko Group can not be held responsible for transmission errors nor
confidentiality of mail and faxes. -

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 
Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 
For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell  
For policy questions, send mail to:
Jim Bacher 
David Heald  
-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 
Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 
For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell  
For policy questions, send mail to:
Jim Bacher 
David Heald  

Re: EN 60601-1-2 50Hz or 60Hz

[emc-p...@ieee.org]

In message 
, dated 
Fri, 16 Jul 2010, Andrew Robbins  writes:

> Is it typical that the testing is performed twice, once with power 
>input at 240/60 and again at 220/50?

Not quite. Twice, yes, but 230/50, not 220/50.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
I should be disillusioned, but it's not worth the effort.   O
But I support unbloated email http://www.asciiribbon.org//\

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

EN 60601-1-2 50Hz or 60Hz

[emc-p...@ieee.org]

Friends and colleagues:
 
Customer needs to perform EMC testing (EN 60601-1-2:2007) on a large medical
device that is rated to operate 240VAC/60Hz or 220VAC/50Hz.  They intend to
use the reports to support an FDA submittal for sales in the US and CE marking
for sales in the EU.  Is it typical that the testing is performed twice, once
with power input at 240/60 and again at 220/50?
 
Andrew Robbins

This message contains information that may be privileged or 
confidential and is the property of the Nemko Group.
It is intended only for the person to whom it is addressed. 
If you are not the intended recipient, you are not authorized to read,
print, retain, copy, disseminate, distribute, or use this message or 
any part thereof. If you receive this message in error, please notify
the sender immediately and delete all copies of this message.
Nemko Group can not be held responsible for transmission errors nor
confidentiality of mail and faxes.
-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL. 
Website: http://www.ieee-pses.org/
Instructions: http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html 
For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell  
For policy questions, send mail to:
Jim Bacher 
David Heald  

Re: EN 60601-1-2 and Annex ZA

[emc-p...@ieee.org]

In message 
, 
dated Tue, 14 Apr 2009, pat.law...@slpower.com writes:

>I'm reading EN 60601-1-2:2001, and I'm not clear on a sentence in Annex 
>ZA. It says: "For undated references the latest edition of the 
>publication referred to applies (including amendments)."
>
>1) Is it the 'latest edition' when EN 60601-1-2:2001 was published? The 
>annex lists the valid edition at that time.  For example, EN 
>61000-4-4:1995

No.
>
>2) Or is it the 'latest edition' at the time the system is tested?  In 
>this case, EN 61000-4-4:2005

Yes.


-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
Things can always get better. But that's not the only option.
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

RE: EN 60601-1-2 and Annex ZA

[emc-p...@ieee.org]

Hi,
Cenelec Guide 25 answers this in its Clause 4 (k):


When there is an undated reference to a basic standard, then
either the latest edition or (if the date of withdrawal of
conflicting standards associated with the latest edition has not
expired) the superseded edition may be applied. After the date
of withdrawal, the latest edition shall be applied.


So it's the #2 in your question.

Regards,
Ari Honkala
SGS Fimko, Finland


From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of
pat.law...@slpower.com
Sent: 15. huhtikuuta 2009 3:52
To: emc-p...@ieee.org
Subject: EN 60601-1-2 and Annex ZA

To all:

I'm reading EN 60601-1-2:2001, and I'm not clear on a sentence in Annex 
ZA. It says:
"For undated references the latest edition of the publication referred
to 
applies (including amendments)." 

1) Is it the 'latest edition' when EN 60601-1-2:2001 was published?  The

annex lists the valid edition at that time.  For example, EN 
61000-4-4:1995

2) Or is it the 'latest edition' at the time the system is tested?  In 
this case, EN 61000-4-4:2005

Pat Lawler
EMC Engineer
SL Power Electronics Corp.

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list. To post a message to the list, send your
e-mail to 

All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that
URL.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 


Information in this email and any attachments is confidential and
intended solely for the use of the individual(s) to whom it is addressed
or otherwise directed. Please note that any views or opinions presented
in this email are solely those of the author and do not necessarily
represent those of the Company.
Finally, the recipient should check this email and any attachments for
the presence of viruses. The Company accepts no liability for any damage
caused by any virus transmitted by this email.
All SGS services are rendered in accordance with the applicable SGS
conditions of service available on request and accessible at
http://www.sgs.com/terms_and_conditions.htm

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

EN 60601-1-2 and Annex ZA

[emc-p...@ieee.org]

To all:

I'm reading EN 60601-1-2:2001, and I'm not clear on a sentence in Annex 
ZA. It says:
"For undated references the latest edition of the publication referred to 
applies (including amendments)." 

1) Is it the 'latest edition' when EN 60601-1-2:2001 was published?  The 
annex lists the valid edition at that time.  For example, EN 
61000-4-4:1995

2) Or is it the 'latest edition' at the time the system is tested?  In 
this case, EN 61000-4-4:2005

Pat Lawler
EMC Engineer
SL Power Electronics Corp.

-

This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to


All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc
Graphics (in well-used formats), large files, etc. can be posted to that URL.

Website:  http://www.ieee-pses.org/
Instructions:  http://listserv.ieee.org/request/user-guide.html
List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:
Scott Douglas 
Mike Cantwell 

For policy questions, send mail to:
Jim Bacher:  
David Heald: 

signal port conducted and 60601-1-2 EMC

[Julian Jones]

this might have to become an offline topic.
 
I am interested in what other labs are doing with regard to LAN/ethernet ports
on ITE products sold as Medical equipment. 
 
60601 calls up CISPR11, which doesn't have Signal Port conducted emission
requirements as CISPR22 does.
 
In this age of litigation I am interested if any labs are testing sig port
under medical emc specs and reporting it as a deviation ?
 
Appreciate any feedback via forum or off line.
 
rgds
 
Julian
 
 
 
 
 
-  This
message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. Website: http://www.ieee-pses.org/ 

To post a message to the list, send your e-mail to emc-p...@ieee.org 

Instructions: http://listserv.ieee.org/request/user-guide.html 

List rules: http://www.ieee-pses.org/listrules.html 

For help, send mail to the list administrators: 

Scott Douglas emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org 

For policy questions, send mail to: 

Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com 

All emc-pstc postings are archived and searchable on the web at: 

http://www.ieeecommunities.org/emc-pstc 

RE: IEC 60601-1-2 Tests on an X-ray Product

[emc-p...@ieee.org]

Raz, et al,

 

It seems to me that you would focus on the use of personal
protective equipment (such as a protective vest as is used on patients under
some conditions) along with a protective shield (often a door or 2 or 3 sided
box with a window to observe) plus have all of the test personnel wear an
x-ray absorption badge that accumulates the exposure over the test time.   

 

I’m sure that the client could help you in planning the process
and procuring the proper equipment to use during this test to minimize the
exposure of your test personnel.  

 

:>) br, Pete

 

Peter E Perkins, PE

Principal Product Safety Engineer

PO Box 23427

Tigard, ORe  97281-3427

 

503/452-1201 fone/fax

p.perk...@ieee.org

 

-  This
message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. Website: http://www.ieee-pses.org/ 

To post a message to the list, send your e-mail to emc-p...@ieee.org 


Instructions: http://listserv.ieee.org/request/user-guide.html 


List rules: http://www.ieee-pses.org/listrules.html 


For help, send mail to the list administrators: 


Scott Douglas emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org 


For policy questions, send mail to: 


Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com 


All emc-pstc postings are archived and searchable on the web at: 


http://www.ieeecommunities.org/emc-pstc 

Re: IEC 60601-1-2 Tests on an X-ray Product

[emc-p...@ieee.org]

X-rays are out of my league but:

1. Isn't there some sort of "dummy load" that could be used (or is that
lead)?
2. I would think that there is also a repair service mode that would have
been devised for field technicians.
3. There is the possibility of testing the equipment "in-situ" (in a
hospital environment) and/or writing a TCF.

On the other hand, you could let the test personnel know that they will not
be charged for the X-rays. : )

Bob Heller
3M EMC Laboratory, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252
=


   
 "itl-emc user 
 group"
 "Emc-Pstc Group (E-mail 2)" 
 Sent by:   
 emc-p...@ieee.org  cc 
   "Emc-Pstc Group (E-mail)"   
  
 12/27/2005 07:23      Subject 
 AMIEC 60601-1-2 Tests on an X-ray 
   Product 
   
   
   
   
   
   




Dear Group


I would appreciate any opinion concerning the following issue:


The subject product needs to be tested in active X-Ray mode of operation,
raising a problem of exposure of test personnel to about 4 days of ionized
radiation.


Does anyone have any suggestions on maintaining test personnel safety and
keep the FDA satisfied?


Best Regards


Shaike Raz


EMC Laboratory Manager


EMC Laboratory


ITL (Product Testing) Ltd.


Kfar Bin Nun


Israel


Tel: +972-8-979-7799


Fax: +972-8-979-7702


Email: s...@itl.co.il/e...@itl.co.il


http://www.itl.co.il


This e-mail message may contain privileged or confidential information. If
you are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.

-

This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Scott Douglas   emcp...@ptcnh.net
 Mike Cantwell   mcantw...@ieee.org

For policy questions, send mail to:

 Jim Bacher: j.bac...@ieee.org
 David Heald:emc-p...@daveheald.com

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

IEC 60601-1-2 Tests on an X-ray Product

[emc-p...@ieee.org]

Dear Group

I would appreciate any opinion concerning the following issue:

The subject product needs to be tested in active X-Ray mode of operation,
raising a problem of exposure of test personnel to about 4 days of ionized
radiation. 

Does anyone have any suggestions on maintaining test personnel safety and keep
the FDA satisfied?

Best Regards

Shaike Raz

EMC Laboratory Manager

EMC Laboratory

ITL (Product Testing) Ltd.

Kfar Bin Nun

Israel

Tel: +972-8-979-7799

Fax: +972-8-979-7702

Email: s...@itl.co.il/e...@itl.co.il

http://www.itl.co.il

This e-mail message may contain privileged or confidential information. If you
are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the message
and its attachments to the sender.

-  This
message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. Website: http://www.ieee-pses.org/ 

To post a message to the list, send your e-mail to emc-p...@ieee.org 


Instructions: http://listserv.ieee.org/request/user-guide.html 


List rules: http://www.ieee-pses.org/listrules.html 


For help, send mail to the list administrators: 


Scott Douglas emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org 


For policy questions, send mail to: 


Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com 


All emc-pstc postings are archived and searchable on the web at: 


http://www.ieeecommunities.org/emc-pstc

Definition of physiological parameter as used in IEC / EN 60601-1 -2:2001

[owner-emc-p...@listserv.ieee.org]

 
Greetings and Happy New Year,
 
I have a question on the definition of physiological parameter.  Specifically
on how it is used to determine the modulation frequency for radiated and
conducted RF immunity testing as specified in IEC/EN 60601-1-2:2001.
 
Clause 36.202.3 b) 3) indicates the method of amplitude modulation.  To
summarize:  The modulation frequency is to be 2 Hz for equipment and systems
that monitor, measure or control a physiological parameter.  1000 Hz
modulation for all other equipment.
 
I am trying to determine if 2 Hz modulation should be applied to MRI systems
and components.
 
Interpretation of the standard is welcome, but a specific reference on how to
apply the clause would be very helpful.
 
Thank you,
 
Michael Peters

The information transmitted in this message is confidential and may be
privileged. Any review, retransmission, dissemination, or other use of this
information by persons or entities other than the intended recipient is
prohibited. If you are not the intended recipient, please notify Analogic
Corporation immediately - by replying to this message or by sending an email
to deliveryerr...@analogic.com - and destroy all copies of this information
without reading or disclosing them.

Thank you.

 This message
is from the IEEE Product Safety Engineering Society emc-pstc discussion list.
Website: http://www.ieee-pses.org/ 

To post a message to the list, send your e-mail to emc-p...@ieee.org 


Instructions: http://listserv.ieee.org/listserv/request/user-guide.html 


List rules: http://www.ieee-pses.org/listrules.html 


For help, send mail to the list administrators: 


Scott Douglas emcp...@ptcnh.net Mike Mcantwell mcantw...@ieee.org 


For policy questions, send mail to: 


Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org 


All emc-pstc postings are archived and searchable on the web at: 


http://www.ieeecommunities.org/emc-pstc

Re: EN 60601-1-2

[owner-emc-p...@listserv.ieee.org]

Bob Heller wrote:
>> ...common sense to me that you would want your equipment to conform to
Class B
especially if you are using it in an operating room or an intensive care
unit but I cannot find this in the standard. It seems to imply that
equipment can be either Class A or Class B especially in hospitals that are
on their own power system. Have I overlooked something? <<

Well, the emissions test applies the limits of CISPR-11; A or B depending
on what level of protection must be afforded radio users.  You'll remember
that there has been some controversy over approving use of electrosurgical
equipment in residential environments.  I'd think a good deal of the answer
comes from one's customers.

Would hospitals tolerate interference with RF patient monitoring?  ER
ambulance comms?  How often, and how much? Running an electrocautery device
might be tolerated for a few moments; a constant dead carrier on-channel
>from a digital clock might be quite another matter.  I think perhaps it is
asking too much of a standard for devices to prescribe interference levels
for facilities. But it would not surprise me if there were a European EMC
standard for medical facilities.

Cortland Richmond


This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/listserv/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Ron Pickard:  emc-p...@hypercom.com
 Scott Douglas emcp...@ptcnh.net

For policy questions, send mail to:

 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

Re: EN 60601-1-2

[owner-emc-p...@listserv.ieee.org]

You haven't overlooked anything Bob.  The standard was written to allow the
intended use environment dictate the emissions class.  In most of Europe, the
hospital is considered a Class A emissions environment (Dutch Natioanl
Committee doesn't like that).  Home use is clearly Class B.  One of the tasks
our committee (SC62A MT-23) is tasked to do is create recommendations for
emissions and immunity levels for other environments such as transport
(ambulance, air, etc).

Regards,

Brent DeWitt
Laboratory Manager
CKC Laboratories
Redmond, WA


From: rehel...@mmm.com
Sent: Oct 27, 2004 7:01 AM
To: emc-p...@ieee.org
Subject: EN 60601-1-2

In the 2002 version of EN 60601-1-2, I cannot find specific emission level
requirements for equipment that is sold for use in a hospital. It seems
common sense to me that you would want your equipment to conform to Class B
especially if you are using it in an operating room or an intensive care
unit but I cannot find this in the standard. It seems to imply that
equipment can be either Class A or Class B especially in hospitals that are
on their own power system. Have I overlooked something?

Bob Heller
3M EMC Laboratory, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252
===


This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/listserv/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Ron Pickard:  emc-p...@hypercom.com
 Scott Douglas emcp...@ptcnh.net

For policy questions, send mail to:

 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc


This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/listserv/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Ron Pickard:  emc-p...@hypercom.com
 Scott Douglas emcp...@ptcnh.net

For policy questions, send mail to:

 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

Fw: EN 60601-1-2

[owner-emc-p...@listserv.ieee.org]

Bob,

No, you haven't overlooked anything. The standard allows either level "based
on their intended use" (clause 36.201.1). Annex CCC gives some guidelines,
but basically Class A is generally acceptable for hospitals and Class B for
medical devices for home use.

As a comment on the approach to EMC for medical devices, I would say the
standards seem to say "do the best you can, but don't let EMC considerations
prevent effective medical treatment if compliance is impossible". I give as
an example the particular standard for lithotripters, IEC 60601-2-36.
Lithotripters are used to break up kidney stones, and work on the basis of
mechanical shocks produced by a spark plug fired under water. As you could
guess, such a device has little chance of complying with emissions
requirements. Clause 36 of IEC 60601-2-36 states "Compliance with IEC
60601-1-2 will be maintained, except during the triggering and generation
cycle of the pressure pulse release." - basically the device has to comply,
except when it's actually in use!!.

Regards,

Jon Griver
http://www.601help.com
The Medical Device Developer's Guide to IEC 60601-1






From: 
To: 
Sent: Wednesday, October 27, 2004 4:01 PM
Subject: EN 60601-1-2


> In the 2002 version of EN 60601-1-2, I cannot find specific emission level
> requirements for equipment that is sold for use in a hospital. It seems
> common sense to me that you would want your equipment to conform to Class
B
> especially if you are using it in an operating room or an intensive care
> unit but I cannot find this in the standard. It seems to imply that
> equipment can be either Class A or Class B especially in hospitals that
are
> on their own power system. Have I overlooked something?
>
> Bob Heller
> 3M EMC Laboratory, 76-1-01
> St. Paul, MN 55107-1208
> Tel:  651- 778-6336
> Fax:  651-778-6252
> ===
>
> 
> This message is from the IEEE Product Safety Engineering Society
> emc-pstc discussion list.Website:  http://www.ieee-pses.org/
>
> To post a message to the list, send your e-mail to emc-p...@ieee.org
>
> Instructions:  http://listserv.ieee.org/listserv/request/user-guide.html
>
> List rules: http://www.ieee-pses.org/listrules.html
>
> For help, send mail to the list administrators:
>
>  Ron Pickard:  emc-p...@hypercom.com
>  Scott Douglas emcp...@ptcnh.net
>
> For policy questions, send mail to:
>
>  Richard Nute:   ri...@ieee.org
>  Jim Bacher: j.bac...@ieee.org
>
> All emc-pstc postings are archived and searchable on the web at:
>
> http://www.ieeecommunities.org/emc-pstc


This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/listserv/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Ron Pickard:  emc-p...@hypercom.com
 Scott Douglas emcp...@ptcnh.net

For policy questions, send mail to:

 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

EN 60601-1-2

[owner-emc-p...@listserv.ieee.org]

In the 2002 version of EN 60601-1-2, I cannot find specific emission level
requirements for equipment that is sold for use in a hospital. It seems
common sense to me that you would want your equipment to conform to Class B
especially if you are using it in an operating room or an intensive care
unit but I cannot find this in the standard. It seems to imply that
equipment can be either Class A or Class B especially in hospitals that are
on their own power system. Have I overlooked something?

Bob Heller
3M EMC Laboratory, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252
===


This message is from the IEEE Product Safety Engineering Society
emc-pstc discussion list.Website:  http://www.ieee-pses.org/

To post a message to the list, send your e-mail to emc-p...@ieee.org

Instructions:  http://listserv.ieee.org/listserv/request/user-guide.html

List rules: http://www.ieee-pses.org/listrules.html

For help, send mail to the list administrators:

 Ron Pickard:  emc-p...@hypercom.com
 Scott Douglas emcp...@ptcnh.net

For policy questions, send mail to:

 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:

http://www.ieeecommunities.org/emc-pstc

RE: 60601-1-2:2002

[John Cronin]

Hi 

I believe it has been published on 13 Dec 2002.  Go to link 

http://europa.eu.int/eur-lex/pri/en/oj/
at/2002/c_310/c_31020021213en00040011.pdf

 

It is En 6061-1-2:2001and has a DOW of 1.11.2004

 

John Cronin

>From: "Brodie Pedersen" 
>Reply-To: "Brodie Pedersen" 
>To: , 
>Subject: RE: 60601-1-2:2002 
>Date: Tue, 18 Feb 2003 08:57:17 -0600 
> 
> 
>I would suggest using the new version as it has been recognized by the 
>FDA for submission in your 510K. I had thought it was published in the 
>OJ also but I must have been mistaken. 
> 
>Brodie Pedersen 
>Nonin Medical Inc. 
> 
>-Original Message- 
>From: rehel...@mmm.com [mailto:rehel...@mmm.com] 
>Sent: Monday, February 17, 2003 4:37 AM 
>To: emc-p...@majordomo.ieee.org 
>Subject: 60601-1-2:2002 
> 
> 
> 
>Is EN 60601-1-2:2002 listed in the OJ? I can only find reference to the 
>1993 version. Can we officially use the latest version? 
> 
>Bob Heller 
>3M EMC Laboratory, 76-1-01 
>St. Paul, MN 55107-1208 
>Tel: 651- 778-6336 
>Fax: 651-778-6252 
>=== 
> 
> 
>--- 
>This message is from the IEEE EMC Society Product Safety Technical 
>Committee emc-pstc discussion list. 
> 
>Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ 
> 
>To cancel your subscription, send mail to: 
> majord...@ieee.org 
>with the single line: 
> unsubscribe emc-pstc 
> 
>For help, send mail to the list administrators: 
> Ron Pickard: emc-p...@hypercom.com 
> Dave Heald: davehe...@attbi.com 
> 
>For policy questions, send mail to: 
> Richard Nute: ri...@ieee.org 
> Jim Bacher: j.bac...@ieee.org 
> 
>Archive is being moved, we will announce when it is back on-line. All 
>emc-pstc postings are archived and searchable on the web at: 
> http://www.ieeecommunities.org/emc-pstc 
> 
>--- 
>This message is from the IEEE EMC Society Product Safety 
>Technical Committee emc-pstc discussion list. 
> 
>Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ 
> 
>To cancel your subscription, send mail to: 
> majord...@ieee.org 
>with the single line: 
> unsubscribe emc-pstc 
> 
>For help, send mail to the list administrators: 
> Ron Pickard: emc-p...@hypercom.com 
> Dave Heald: davehe...@attbi.com 
> 
>For policy questions, send mail to: 
> Richard Nute: ri...@ieee.org 
> Jim Bacher: j.bac...@ieee.org 
> 
>Archive is being moved, we will announce when it is back on-line. 
>All emc-pstc postings are archived and searchable on the web at: 
> http://www.ieeecommunities.org/emc-pstc 

  _  

Send instant messages for free with MSN Messenger. Click here to download it
now! <http://g.msn.com/8HMXENUK/2740>  
--- This message is from the IEEE EMC
Society Product Safety Technical Committee emc-pstc discussion list. Visit our
web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your
subscription, send mail to: majord...@ieee.org with the single line:
unsubscribe emc-pstc For help, send mail to the list administrators: Ron
Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy
questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher:
j.bac...@ieee.org Archive is being moved, we will announce when it is back
on-line. All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: 60601-1-2:2002

[Brodie Pedersen]

I would suggest using the new version as it has been recognized by the
FDA for submission in your 510K.  I had thought it was published in the
OJ also but I must have been mistaken.

Brodie Pedersen
Nonin Medical Inc.


From: rehel...@mmm.com [mailto:rehel...@mmm.com] 
Sent: Monday, February 17, 2003 4:37 AM
To: emc-p...@majordomo.ieee.org
Subject: 60601-1-2:2002



Is EN 60601-1-2:2002 listed in the OJ? I can only find reference to the
1993 version. Can we officially use the latest version?

Bob Heller
3M EMC Laboratory, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252
===



This message is from the IEEE EMC Society Product Safety Technical
Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line. All
emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

Rif: Re: 60601-1-2:2002

[Paolo Peruzzi]

Hi all,

As far as I know, EN 60601-1-2 (2001) is listed on OJ since last december,
see:
http://europa.eu.int/eur-lex/it/dat/2002/c_310/c_31020021213it00040011.pdf

Best regards,
Paolo Peruzzi

**
Paolo Peruzzi
Esaote S.p.A.
Research & Product Development -  Design Quality Control
via di Caciolle, 15   I- 50127 Florence
tel: +39 055 4229469
fax: +39 055 4223305
e-mail: paolo.peru...@esaote.com
**


  
  
  has...@a-pex.co.jp  
  
  Inviato da:Per: rehel...@mmm.com
  
  owner-emc-pstc@majordo Cc: 
emc-p...@majordomo.ieee.org
  mo.ieee.orgCcr: 
  
 Oggetto: Re:
60601-1-2:2002 
  
  
  17/02/2003 11.56
  
  Per favore, rispondere  
  
  a hasimt
  
  
  
  
  



Hello Bob,

Not, yet.
You can check it below web site.
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/r
eflist/meddevic.html

But I think you should use new version, if available.

Best regards,
Tetsuya Hashimoto
A-PEX International Co.Ltd.
www.a-pex.co.jp

> Is EN 60601-1-2:2002 listed in the OJ? I can only find reference to the
> 1993 version. Can we officially use the latest version?
>
> Bob Heller
> 3M EMC Laboratory, 76-1-01
> St. Paul, MN 55107-1208
> Tel:  651- 778-6336
> Fax:  651-778-6252
> ===
>
>




This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc




CONFIDENTIALITY NOTICE

The materials in this electronic mail transmission
(including all attachments) are private and confidential
and are the property of Esaote SpA.
Unauthorized disclosure, copying, distribution,
or the taking of any action in reliance on the contents
of this material is strictly prohibited.
Please notify the sender if you have received this in error.

Le informazioni contenute in questo messaggio di
posta elettronica e relativi allegati sono proprietà di
Esaote SpA e sono riservate;
ne é vietata la diffusione in qualunque modo eseguita.
Qualora Lei non fosse la persona a cui il presente
messaggio è destinato, La invitiamo ad eliminarlo e
ad informare colui che lo ha inviato.





This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

Re: 60601-1-2:2002

[has...@a-pex.co.jp]

Hello Bob,

Not, yet.
You can check it below web site.
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/r
eflist/meddevic.html

But I think you should use new version, if available.

Best regards,
Tetsuya Hashimoto
A-PEX International Co.Ltd.
www.a-pex.co.jp

> Is EN 60601-1-2:2002 listed in the OJ? I can only find reference to the
> 1993 version. Can we officially use the latest version?
>
> Bob Heller
> 3M EMC Laboratory, 76-1-01
> St. Paul, MN 55107-1208
> Tel:  651- 778-6336
> Fax:  651-778-6252
> ===
>
>




This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

60601-1-2:2002

[rehel...@mmm.com]

Is EN 60601-1-2:2002 listed in the OJ? I can only find reference to the
1993 version. Can we officially use the latest version?

Bob Heller
3M EMC Laboratory, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252
===



This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

Archive is being moved, we will announce when it is back on-line.
All emc-pstc postings are archived and searchable on the web at:
http://www.ieeecommunities.org/emc-pstc

RE: EN 60601-1-2/ EN 55022: 1998

[Jim Conrad]

EN 60601-1-2:2001 was just published in the OJ. The CENELEC web site
has not been updated yet.

Best Regards,

Jim

Jim Conrad, Convenor IEC SC62A/MT23
P.O. Box 25
Hamilton, MA 01936 U.S.A.

E-mail:   jc...@shore.net

Phone:  978-468-3909
FAX:  978-468-1034


From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of ITL-EMC User
Group
Sent: Monday, January 06, 2003 12:57 AM
To: Emc-Pstc Group (E-mail)
Subject: EN 60601-1-2/ EN 55022: 1998


Thanks to all who replied.
I was pretty sure about EN 55022: 1998 but wanted to make sure.
Anything about the new edition of IEC/EN 60601-1-2?
> David Shidlowsky
> Technical Writer
> EMC Laboratory
> ITL (Product Testing) Ltd.
> Kfar Bin Nun
> Israel
> Tel: +972-8-9797799
> Fax: +972-8-9797702
> Email: dav...@itl.co.il
> http://www.itl.co.il
> http://www.i-spec.com
> This e-mail message may contain privileged or confidential
information. If
> you are not the intended recipient, you may not disclose, use,
> disseminate, distribute, copy or rely upon this message or
attachment in
> any way. If you received this e-mail message in error, please
return by
> forwarding the message and its attachments to the sender.
>
>
>
>  -Original Message-
> From: ITL-EMC User Group
> Sent: Sunday, January 05, 2003 7:50 AM
> To:   Emc-Pstc Group (E-mail)
> Subject:  EN 60601-1-2/ EN 55022: 1998
>
> Dear All,
> I have read in various places that the new edition of IEC/EN
60601-1-2 is
> in effect (FDA in the US).
> As yet, only EN 60601-1-2: 1993 is listed in the OJ (December
2002).
> Does anyone know when the new edition will be listed in the OJ and
thus
> become official?
> Regarding EN 55022: 1998 + Amendment A1: 2000, I have also read
that the
> application of this standard is being delayed. Does anyone have
any
> information as to when it will become applicable?
> Thanks
> David Shidlowsky
> Technical Writer
> EMC Laboratory
> ITL (Product Testing) Ltd.
> Kfar Bin Nun
> Israel
> Tel: +972-8-9797799
> Fax: +972-8-9797702
> Email: dav...@itl.co.il
> http://www.itl.co.il
> http://www.i-spec.com
> This e-mail message may contain privileged or confidential
information. If
> you are not the intended recipient, you may not disclose, use,
> disseminate, distribute, copy or rely upon this message or
attachment in
> any way. If you received this e-mail message in error, please
return by
> forwarding the message and its attachments to the sender.
>
>


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"



This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

Re: EN 60601-1-2/ EN 55022: 1998

[brent.dew...@us.datex-ohmeda.com]

David,

EN 60601-1-2:2001 (i.e. IEC 60601-1-2) was published in
the Official Journal Dec 13, 2002 with reference to the MDD, i.e. it is now
officially harmonized. The date of cessation of presumption of conformity
by
applying the superseded standard EN 60601-1-2:1993 has been set to
2004-11-01 (Nov. 1, 2004).

Regards,

Brent DeWitt
Datex-Ohmeda
Louisville, CO





ITL-EMC User Group @majordomo.ieee.org on 04-01-2003
10:46:59 PM

Please respond to ITL-EMC User Group 

Sent by:  owner-emc-p...@majordomo.ieee.org


To:   "Emc-Pstc Group (E-mail)" 
cc:

Subject:  EN 60601-1-2/ EN 55022: 1998



Dear All,
I have read in various places that the new edition of IEC/EN 60601-1-2 is
in
effect (FDA in the US).
As yet, only EN 60601-1-2: 1993 is listed in the OJ (December 2002).
Does anyone know when the new edition will be listed in the OJ and thus
become official?
Regarding EN 55022: 1998 + Amendment A1: 2000, I have also read  that the
application of this standard is being delayed. Does anyone have any
information as to when it will become applicable?
Thanks
> David Shidlowsky
> Technical Writer
> EMC Laboratory
> ITL (Product Testing) Ltd.
> Kfar Bin Nun
> Israel
> Tel: +972-8-9797799
> Fax: +972-8-9797702
> Email: dav...@itl.co.il
> http://www.itl.co.il
> http://www.i-spec.com
> This e-mail message may contain privileged or confidential information.
If
> you are not the intended recipient, you may not disclose, use,
> disseminate, distribute, copy or rely upon this message or attachment in
> any way. If you received this e-mail message in error, please return by
> forwarding the message and its attachments to the sender.
>
>


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"





This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

EN 60601-1-2/ EN 55022: 1998

[ITL-EMC User Group]

Thanks to all who replied.
I was pretty sure about EN 55022: 1998 but wanted to make sure.
Anything about the new edition of IEC/EN 60601-1-2?
> David Shidlowsky
> Technical Writer
> EMC Laboratory
> ITL (Product Testing) Ltd.
> Kfar Bin Nun
> Israel
> Tel: +972-8-9797799
> Fax: +972-8-9797702
> Email: dav...@itl.co.il
> http://www.itl.co.il
> http://www.i-spec.com
> This e-mail message may contain privileged or confidential information. If
> you are not the intended recipient, you may not disclose, use,
> disseminate, distribute, copy or rely upon this message or attachment in
> any way. If you received this e-mail message in error, please return by
> forwarding the message and its attachments to the sender.
> 
> 
> 
>  -Original Message-
> From: ITL-EMC User Group  
> Sent: Sunday, January 05, 2003 7:50 AM
> To:   Emc-Pstc Group (E-mail)
> Subject:  EN 60601-1-2/ EN 55022: 1998
> 
> Dear All,
> I have read in various places that the new edition of IEC/EN 60601-1-2 is
> in effect (FDA in the US).
> As yet, only EN 60601-1-2: 1993 is listed in the OJ (December 2002).
> Does anyone know when the new edition will be listed in the OJ and thus
> become official?
> Regarding EN 55022: 1998 + Amendment A1: 2000, I have also read  that the
> application of this standard is being delayed. Does anyone have any
> information as to when it will become applicable?
> Thanks
> David Shidlowsky
> Technical Writer
> EMC Laboratory
> ITL (Product Testing) Ltd.
> Kfar Bin Nun
> Israel
> Tel: +972-8-9797799
> Fax: +972-8-9797702
> Email: dav...@itl.co.il
> http://www.itl.co.il
> http://www.i-spec.com
> This e-mail message may contain privileged or confidential information. If
> you are not the intended recipient, you may not disclose, use,
> disseminate, distribute, copy or rely upon this message or attachment in
> any way. If you received this e-mail message in error, please return by
> forwarding the message and its attachments to the sender.
> 
> 


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

Re: EN 60601-1-2/ EN 55022: 1998

[John Woodgate]

I read in !emc-pstc that John Barnes  wrote (in
<3e184ad6.7...@iglou.com>) about 'EN 60601-1-2/ EN 55022: 1998' on Sun,
5 Jan 2003:
>The date of cessation of presumption
>on conformity of the superseded standard (DOPOCOSS) is 1 AUG 2003. 

You left out one of the molecules of carbon monoxide: it's DOCOPOCOSS.
(;-)
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

Re: EN 60601-1-2/ EN 55022: 1998

[John Barnes]

David,
EN 55022:1998 + Amendment A1:2000 was listed in the Official Journal of
the European Community on 26 JUL 2001, in C208 Volume 44.  So you have
had the *option* of using it since then.  It is still included in the
latest listing of harmonized standards for the EMC directive, which came
out 7 DEC 2002, in C304 Volume 45.  The date of cessation of presumption
on conformity of the superseded standard (DOPOCOSS) is 1 AUG 2003.  

So EN 55022:1994 and its amendments are valid for only another seven
months.  This worries a number of EMC and design engineers that I know,
because EN 55022:1998 has Conducted Common Mode Voltage/Current Limits
for Telecommunication Ports that aren't in EN 55022:1994.  And to date,
local area network (LAN) ports like Ethernet have had a very hard time
meeting these limits.

If you would like a lot more information about EN 55022, please read our
web page about emission standards for ITE at:
 http://www.dbicorporation.com/emission.htm

John Barnes KS4GL, PE, NCE, ESDC Eng, SM IEEE
dBi Corporation
http://www.dbicorporation.com/


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

RE: EN 60601-1-2/ EN 55022: 1998

[Helge Knudsen]

 Hello David,
Regarding EN 55022: 1998 + Amendment A1: 2000 are to become effective 1.
August 2003, see latest OJ-list at
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/wh
atsnew.html 

Best regards

Helge Knudsen 
Niros Telecommunication 
Hirsemarken 5 
DK-3520 Farum 
Denmark 
Tel +45 44 34 22 51 
Fax +45 44 99 28 08 
email h.knud...@niros.com 


From: ITL-EMC User Group
To: Emc-Pstc Group (E-mail)
Sent: 05-01-2003 06:46
Subject: EN 60601-1-2/ EN 55022: 1998


Dear All,
I have read in various places that the new edition of IEC/EN 60601-1-2
is in
effect (FDA in the US).
As yet, only EN 60601-1-2: 1993 is listed in the OJ (December 2002).
Does anyone know when the new edition will be listed in the OJ and thus
become official?
Regarding EN 55022: 1998 + Amendment A1: 2000, I have also read  that
the
application of this standard is being delayed. Does anyone have any
information as to when it will become applicable?
Thanks
> David Shidlowsky
> Technical Writer
> EMC Laboratory
> ITL (Product Testing) Ltd.
> Kfar Bin Nun
> Israel
> Tel: +972-8-9797799
> Fax: +972-8-9797702
> Email: dav...@itl.co.il
> http://www.itl.co.il
> http://www.i-spec.com
> This e-mail message may contain privileged or confidential
information. If
> you are not the intended recipient, you may not disclose, use,
> disseminate, distribute, copy or rely upon this message or attachment
in
> any way. If you received this e-mail message in error, please return
by
> forwarding the message and its attachments to the sender.
> 
> 


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

EN 60601-1-2/ EN 55022: 1998

[ITL-EMC User Group]

Dear All,
I have read in various places that the new edition of IEC/EN 60601-1-2 is in
effect (FDA in the US).
As yet, only EN 60601-1-2: 1993 is listed in the OJ (December 2002).
Does anyone know when the new edition will be listed in the OJ and thus
become official?
Regarding EN 55022: 1998 + Amendment A1: 2000, I have also read  that the
application of this standard is being delayed. Does anyone have any
information as to when it will become applicable?
Thanks
> David Shidlowsky
> Technical Writer
> EMC Laboratory
> ITL (Product Testing) Ltd.
> Kfar Bin Nun
> Israel
> Tel: +972-8-9797799
> Fax: +972-8-9797702
> Email: dav...@itl.co.il
> http://www.itl.co.il
> http://www.i-spec.com
> This e-mail message may contain privileged or confidential information. If
> you are not the intended recipient, you may not disclose, use,
> disseminate, distribute, copy or rely upon this message or attachment in
> any way. If you received this e-mail message in error, please return by
> forwarding the message and its attachments to the sender.
> 
> 


This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

RE: 60601-1-2

[Brodie Pedersen]

Hello Bob,
The document has not been published in the OJ yet but it has been recognized by 
the FDA for use where the 1983 version was not recognized for use in the US.  

Brodie Pedersen 
Nonin Medical Inc.

-Original Message-
From: Véronique Beauvois [mailto:v.beauv...@ulg.ac.be] 
Sent: Friday, October 25, 2002 11:18 AM
To: rehel...@mmm.com
Cc: emc-p...@majordomo.ieee.org
Subject: Re: 60601-1-2



Hello Bob,

Point to : 
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

Regards,

Véronique

rehel...@mmm.com wrote:

>Has the version EN 60601-1-2 : 2002 been published in the OJ yet? Or is 
>the 1993 version still the latest? Can someone point me to the web for 
>the latest harmonized standards list to the Medical Device Directive?
>
>Thanks,
>Bob Heller
>3M Product Safety, 76-1-01
>St. Paul, MN 55107-1208
>Tel:  651- 778-6336
>Fax:  651-778-6252
>
>
>---
>This message is from the IEEE EMC Society Product Safety Technical 
>Committee emc-pstc discussion list.
>
>Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/
>
>To cancel your subscription, send mail to:
> majord...@ieee.org
>with the single line:
> unsubscribe emc-pstc
>
>For help, send mail to the list administrators:
> Ron Pickard:  emc-p...@hypercom.com
> Dave Heald:   davehe...@attbi.com
>
>For policy questions, send mail to:
> Richard Nute:   ri...@ieee.org
> Jim Bacher: j.bac...@ieee.org
>
>All emc-pstc postings are archived and searchable on the web at:
>http://ieeepstc.mindcruiser.com/
>Click on "browse" and then "emc-pstc mailing list"
>
>  
>

-- 
Ir. Véronique Beauvois

Université de Liège
Département d'Electricité, Electronique et Informatique
Service d'Electricité Appliquée (Prof. W. Legros)
Institut Montefiore B28
4000 LIEGE - BELGIQUE
Tél: +32-4-3663746
GSM: 0477/87.12.80
Fax: +32-4-3662910
http://elap.montefiore.ulg.ac.be




---
This message is from the IEEE EMC Society Product Safety Technical Committee 
emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

Re: 60601-1-2

[John Woodgate]

I read in !emc-pstc that Gert Gremmen  wrote (in
) about '60601-1-2' on
Fri, 25 Oct 2002:
>No it has not been harmonised yet.

Being an EN, it is, ipso facto, harmonized in all the EU countries. It
has not been **notified** yet. 

The Commission seems to have tried to hi-jack the term 'harmonized' from
the standards world, where it means that it is accepted by every member
of a group (which may even be all the members of IEC or ISO!), and
restrict it to the ENs that the Commission likes. 
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

Re: 60601-1-2

[Véronique Beauvois]

Hello Bob,

Point to :
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

Regards,

Véronique

rehel...@mmm.com wrote:


Has the version EN 60601-1-2 : 2002 been published in the OJ yet? Or is the
1993 version still the latest? Can someone point me to the web for the
latest harmonized standards list to the Medical Device Directive?

Thanks,
Bob Heller
3M Product Safety, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
majord...@ieee.org
with the single line:
unsubscribe emc-pstc

For help, send mail to the list administrators:
Ron Pickard:  emc-p...@hypercom.com
Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
Richard Nute:   ri...@ieee.org
Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
   http://ieeepstc.mindcruiser.com/
   Click on "browse" and then "emc-pstc mailing list"

 



--
Ir. Véronique Beauvois

Université de Liège
Département d'Electricité, Electronique et Informatique
Service d'Electricité Appliquée (Prof. W. Legros)
Institut Montefiore B28
4000 LIEGE - BELGIQUE
Tél: +32-4-3663746
GSM: 0477/87.12.80
Fax: +32-4-3662910
http://elap.montefiore.ulg.ac.be




---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
majord...@ieee.org
with the single line:
unsubscribe emc-pstc

For help, send mail to the list administrators:
Ron Pickard:  emc-p...@hypercom.com
Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
Richard Nute:   ri...@ieee.org
Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
   http://ieeepstc.mindcruiser.com/
   Click on "browse" and then "emc-pstc mailing list"

RE: 60601-1-2

[Gert Gremmen]

Hi Bob,

The required list you can find on :

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re
flist/meddevic.html

No it has not been harmonised yet.

Gert Gremmen

ce-test,qualified testing


-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of rehel...@mmm.com
Sent: vrijdag 25 oktober 2002 16:03
To: emc-p...@majordomo.ieee.org
Subject: 60601-1-2



Has the version EN 60601-1-2 : 2002 been published in the OJ yet? Or is the
1993 version still the latest? Can someone point me to the web for the
latest harmonized standards list to the Medical Device Directive?

Thanks,
Bob Heller
3M Product Safety, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"




---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

60601-1-2

[reheller]

Has the version EN 60601-1-2 : 2002 been published in the OJ yet? Or is the
1993 version still the latest? Can someone point me to the web for the
latest harmonized standards list to the Medical Device Directive?

Thanks,
Bob Heller
3M Product Safety, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

RE: EN 60601-1-2

[Jim Conrad]

It seems a bit strange that they have not listed it in the OJ yet
but I am told it is coming soon.  I think the important thing is
that CENELEC approved it in Sept of 2001 and have now published the
DOR, DOP, DOW on their web site.  Now we just have to wait for the
OJ publication that should happen in November.

Best Regards,

Jim

Jim Conrad, Convenor IEC SC62A/MT23
P.O. Box 25
Hamilton, MA 01936 U.S.A.

E-mail:   jc...@shore.net

Phone:  978-468-3909
FAX:  978-468-1034

-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of ITL-EMC User
Group
Sent: Tuesday, September 24, 2002 2:51 AM
To: emc-p...@majordomo.ieee.org
Subject: EN 60601-1-2


Hi all,
Has anyone heard when the latest edition of EN 60601-1-2 will be
published
in the Official Journal?
I have received enquiries from customers regarding the new edition.
Thanks to anyone who can help.
Regards

David Shidlowsky
Technical Writer
EMC Laboratory
ITL (Product Testing) Ltd.
Kfar Bin Nun
Israel
Tel: +972-8-9797799
Fax: +972-8-9797702
Email: dav...@itl.co.il
http://www.itl.co.il
http://www.i-spec.com
This e-mail message may contain privileged or confidential
information. If
you are not the intended recipient, you may not disclose, use,
disseminate,
distribute, copy or rely upon this message or attachment in any way.
If you
received this e-mail message in error, please return by forwarding
the
message and its attachments to the sender.



---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

EN 60601-1-2

[ITL-EMC User Group]

Hi all,
Has anyone heard when the latest edition of EN 60601-1-2 will be published
in the Official Journal?
I have received enquiries from customers regarding the new edition.
Thanks to anyone who can help.
Regards

David Shidlowsky
Technical Writer
EMC Laboratory
ITL (Product Testing) Ltd.
Kfar Bin Nun
Israel
Tel: +972-8-9797799
Fax: +972-8-9797702
Email: dav...@itl.co.il
http://www.itl.co.il
http://www.i-spec.com
This e-mail message may contain privileged or confidential information. If
you are not the intended recipient, you may not disclose, use, disseminate,
distribute, copy or rely upon this message or attachment in any way. If you
received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.



---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Ron Pickard:  emc-p...@hypercom.com
 Dave Heald:   davehe...@attbi.com

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
http://ieeepstc.mindcruiser.com/
Click on "browse" and then "emc-pstc mailing list"

RE: IEC 60601-1-2 Second Edition

[Jim Conrad]

Hi Ned,

I think everyone is asking the same question.  You have received the correct
interpretation from the FDA.  The 2nd edition is effective as of 10-2001 and
if you claim compliance with it on your 510k, the FDA will not come back and
ask for more information regarding EMC.  They are however reasonable and do
not expect manufactures to comply on such short notice but they then also
reserve the right to come back and ask you additional questions regarding
the EMC performance of you product which may include why you did not choose
to comply with the 2nd edition of 60601-1-2.  Call me if you want more
information regarding this.

You asked: "Has anyone had any success in doing a risk analysis to use lower
immunity
compliance levels than specified in IEC 60601-1-2, Second Edition, Section
36.202.1 a) or using different compliance criteria (36.202.1 j))? "  The
risk analysis that is call for in the 2nd edition is only to determine which
"functions" of the equipment will be tested for immunity.  Only those
functions that are associated with "essential performance" need be tested.
A risk analysis does not allow "essential performance" to pass at reduced
levels.

Yes, "Clause 6.8.3.201 a) 5), "These justification shall be based only on
physical, technological or physiological limitations..." pretty much
preclude the use of lower limits?"  Your justification for lower immunity
levels must be based on  physical, technological or physiological
limitations.

You stated and asked: "The device in question meets IEC 60601-1-2 First
Edition, but will not pass
the requirements in the Second Edition.  Can the "justification" be that
since there are no known risks on the device, the current level of immunity
is adequate?"  No you cannot use this as a justification because it is not
based on physical, technological or physiological limitations of your
equipment.

Please contact me directly if you need more help.

Best regards,

Jim








-Original Message-
From: owner-emc-p...@majordomo.ieee.org
[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Ned Devine
Sent: Tuesday, February 05, 2002 4:24 PM
To: IEEE EMC/Product Safety (E-mail)
Subject: IEC 60601-1-2 Second Edition


Hi,

I need some help from the EMC experts.

According to FDA Acting Chief of the Brach I am dealing with, since the FDA
has recognized IEC 60601-1-2 Second Edition (October 2001), then "...If they
submit a new 510(k) (or even a modification for an existing device) and we
have recognized the more recent standard, then they would need to comply
with the new standard."   Making the new edition immediately effective seems
a little harsh.  I am appealing his interpretation, but I don't know if I
will have any luck.

Has anyone had any success in doing a risk analysis to use lower immunity
compliance levels than specified in IEC 60601-1-2, Second Edition, Section
36.202.1 a) or using different compliance criteria (36.202.1 j))?  Or does
Clause 6.8.3.201 a) 5), "These justification shall be based only on
physical, technological or physiological limitations..." pretty much
preclude the use of lower limits?

The device in question meets IEC 60601-1-2 First Edition, but will not pass
the requirements in the Second Edition.  Can the "justification" be that
since there are no known risks on the device, the current level of immunity
is adequate?

Thanks

Ned

Ned Devine
Program Manager
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

1 616 248 9671 Phone
1 616 574 9752 Fax
ndev...@entela.com e-mail



---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages are imported into the new server.


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   

RE: IEC 60601-1-2 Second Edition

[Kevin Hight]

Ned,

At a recent AAMI/FDA conference I asked Jeffery Silberberg of the FDA a
similar question and his response was that the new standard would apply upon
the date of recognition by the FDA.  As a matter of business, I have been
using the new standard (in Draft form) for the last year or two.  I do have
some products that will not meet the new standard but will be re-designed
when a modification is made.  For products that are Life Supporting, this
will have a MAJOR impact.  Good luck and let me know how it works out for
you.

Regards,

__
Kevin J. Hight - Principal Compliance Engineer
Colorado MEDtech, Inc.
6175 Longbow Drive, Boulder, Colorado 80301
Phone: (303) 530-8288 x-3111   Fax: (303) 581-1003
Email: k...@cmed.com <mailto:k...@cmed.com>http://www.cmed.com
<http://www.cmed.com> 


-Original Message-
From:   Ned Devine [SMTP:ndev...@entela.com]
Sent:   Tuesday, February 05, 2002 8:24 AM
To: IEEE EMC/Product Safety (E-mail)
Subject:    IEC 60601-1-2 Second Edition 


Hi,

I need some help from the EMC experts.  

According to FDA Acting Chief of the Brach I am dealing with, since
the FDA
has recognized IEC 60601-1-2 Second Edition (October 2001), then
"...If they
submit a new 510(k) (or even a modification for an existing device)
and we
have recognized the more recent standard, then they would need to
comply
with the new standard."   Making the new edition immediately
effective seems
a little harsh.  I am appealing his interpretation, but I don't know
if I
will have any luck.

Has anyone had any success in doing a risk analysis to use lower
immunity
compliance levels than specified in IEC 60601-1-2, Second Edition,
Section
36.202.1 a) or using different compliance criteria (36.202.1 j))?
Or does
Clause 6.8.3.201 a) 5), "These justification shall be based only on
physical, technological or physiological limitations..." pretty much
preclude the use of lower limits?  

The device in question meets IEC 60601-1-2 First Edition, but will
not pass
the requirements in the Second Edition.  Can the "justification" be
that
since there are no known risks on the device, the current level of
immunity
is adequate?

Thanks

Ned

Ned Devine
Program Manager
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

1 616 248 9671 Phone
1 616 574 9752 Fax
ndev...@entela.com e-mail



---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the
old messages are imported into the new server.

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old 
messages are imported into the new server.

IEC 60601-1-2 Second Edition

[Ned Devine]

Hi,

I need some help from the EMC experts.  

According to FDA Acting Chief of the Brach I am dealing with, since the FDA
has recognized IEC 60601-1-2 Second Edition (October 2001), then "...If they
submit a new 510(k) (or even a modification for an existing device) and we
have recognized the more recent standard, then they would need to comply
with the new standard."   Making the new edition immediately effective seems
a little harsh.  I am appealing his interpretation, but I don't know if I
will have any luck.

Has anyone had any success in doing a risk analysis to use lower immunity
compliance levels than specified in IEC 60601-1-2, Second Edition, Section
36.202.1 a) or using different compliance criteria (36.202.1 j))?  Or does
Clause 6.8.3.201 a) 5), "These justification shall be based only on
physical, technological or physiological limitations..." pretty much
preclude the use of lower limits?  

The device in question meets IEC 60601-1-2 First Edition, but will not pass
the requirements in the Second Edition.  Can the "justification" be that
since there are no known risks on the device, the current level of immunity
is adequate?

Thanks

Ned

Ned Devine
Program Manager
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

1 616 248 9671 Phone
1 616 574 9752 Fax
ndev...@entela.com e-mail



---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old 
messages are imported into the new server.

RE: 60601-1-2

[Momcilovic, Nick]

For the latest developments on CENELEC (EN) standards you can go directly to
their website search and just type in the standard number in the "Standard
reference" field (http://www.cenelec.org/BASIS/celis/free/project/SF).

Nick Momcilovic
Product Safety Coordinator

QTI
N64W23110 Main Street
Sussex, WI 53089-5301
USA

Phone:  +1-414-566-7915
Fax:  +1-262-246-5376
mailto:nick.momcilo...@qtiworld.com
http://www.qtiworld.com


-Original Message-
From: rehel...@mmm.com [mailto:rehel...@mmm.com]
Sent: Friday, October 19, 2001 9:31 AM
To: emc-p...@majordomo.ieee.org
Subject: 60601-1-2



I heard that the IEC has issued the new 60601-1-2 EMC standard for medical
equipment on the 30th of September.

Does anyone know when the EN will follow and when its DOW will be?

Thanks,
Bob Heller
3M Product Safety, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old
messages are imported into the new server.

---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old 
messages are imported into the new server.

60601-1-2

[reheller]

I heard that the IEC has issued the new 60601-1-2 EMC standard for medical
equipment on the 30th of September.

Does anyone know when the EN will follow and when its DOW will be?

Thanks,
Bob Heller
3M Product Safety, 76-1-01
St. Paul, MN 55107-1208
Tel:  651- 778-6336
Fax:  651-778-6252


---
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc discussion list.

Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/

To cancel your subscription, send mail to:
 majord...@ieee.org
with the single line:
 unsubscribe emc-pstc

For help, send mail to the list administrators:
 Michael Garretson:pstc_ad...@garretson.org
 Dave Healddavehe...@mediaone.net

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org
 Jim Bacher: j.bac...@ieee.org

All emc-pstc postings are archived and searchable on the web at:
No longer online until our new server is brought online and the old 
messages are imported into the new server.