(Fwd) Medical Devices Environmental Requirements

2002-11-05 Thread jgriver

Joel,

To the best of my knowledge, there are no specific environmental standards for 
medical equipment.

IEC 60601-1, (the product safety standard), clause 10.1, states  Equipment 
shall be capable, while 
packed for transport and storage, of being exposed to environmental conditions 
as stated by the 
manufacturer.

Clause 10.2.1 specifies ambient temperature, relative humidity and atmospheric 
pressure ranges for 
operation in normal use.

Particular types of medical equipment, which are required to comply with one of 
the  IEC 60601-2-XX 
standards, may be subject to additional or different environmental requirements.

Regards,

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


Hi All
 Can anybody help me out with Environmental testing requirement/Standards
(Temp,Vibration) for medical devices?
Thank You
Joel Mandel
Reliability Dept
ADC Israel



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Re: Medical equipment and EN61000-3-2

2002-09-19 Thread jgriver

Patrick,

I don't know whether or not hospital power systems fall within the 
scope of EN61000-3-2:2001. But in any case, compliance with EN61000-3-
2 is not required under the Medical Devices Directive.

The only harmonized EMC standard under the MDD is EN 60601-1-2:1993, 
which does not have any harmonics requirements. Medical equipment is, 
of course, specifically exempted from the EMC Directive.

Regards,

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


On 18 Sep 2002 at 12:55, plaw...@west.net wrote:

 
 The scope of EN61000-3-2:2001 says that the standard deals with harmonic
 currents injected into the public low-voltage distribution system.
 
 I can see that residences and offices are connected to the public system.
 However, I don't know about distribution to hospitals.
 
 Are their power requirements specialized enough that their electricity is
 provided by a MV transformer?  This would exempt hospital-only medical 
 products
 from the harmonic current requirements.
 Or are their different levels of hospitals, some fed by LV transformers, some
 fed by MV transformers?
 
 Patrick Lawler
 plaw...@west.net
 
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Re: Distributors of Medical Devices in Europe

2002-09-18 Thread jgriver

Mark,

I assume that you mean Class 1 according to the EU's Medical Devices 
Directive, and not the FDA classification. Although the principle is 
the same, i.e. Class 1 is low-risk, the classification method is not 
identical.

The MDD deals with the device rather than the distributor. Compliance 
of the device with the MDD is mandatory. You should probably check 
the Health Ministry or 'Competant Authority' (as defined in the MDD), 
to check whether there are requirements on the distributor. As this 
subject is not covered by the MDD, the regulations are likely to be 
different in each country of the EU. You can contact the UK Competent 
Authority via their website at:

http://www.medical-devices.gov.uk/

Distributors would certainly be obligated to report incidents 
involving injury or death to the authorities.

I hope this helps.


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



On 18 Sep 2002 at 8:11, Mark Schmidt wrote:

 
 Hello Group,
 
 Are there any requirements for European Distributors of Medical Devices, i.e. 
 license or registration. The Device in question is a Class 1 device.
 
 Thank you.
 
 Mark Schmidt
 Regulatory Compliance 
 X-Rite Incorporated 
 Grandville, MI 
 USA
 (616) 257 2469
 mschm...@xrite.com
 
 
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Re: Grounding in an operating room environment ...

2002-08-20 Thread jgriver

Doug,

You are really asking if the product is Type B (earthed applied part) or Type 
BF (isolated ground part) according the the classification 
of IEC 60601-1.

The answer is that some types of medical equipment must be Type BF or even Type 
CF (direct cardiac contact) according to the 
appropriate particular standard, IEC 60601-2-X. For many types of equipment it 
is left to the manufacturer to decide.

Generally speaking the longer and more invasive the contact with the patient, 
the more likely that Type BF or CF is required. In 
particular, in situations where many medical instruments may be connected to 
the patient simutaneously, e.g. in the operating room 
or intensive care, there is a greater need for isolated patient applied parts. 
This is to prevent a fault in one device causing dangerous 
leakage currents through the patient to earth via another device.

Regards,


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



One final question - if some product which uses 115/230vac mains 
power and if there is to be metal contact between that product and 
a patient in an operating room environment, is it a matter of accepted 
practice that the mfr can decide the metal is grounded/ungrounded 
or must it be grounded as dictated by some standard? 

Regards, Doug McKean 


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(Fwd) Medical devices, current limit

2002-08-15 Thread jgriver

Kim,

This type of product may be covered by IEC 60601-2-10, PARTICULAR REQUIREMENTS 
FOR THE SAFETY OF NERVE AND 
MUSCLE STIMULATORS, 
or possibly, IEC 60601-2-14, PARTICULAR REQUIREMENTS FOR THE SAFETY OF 
ELECTROCONVULSIVE THERAPY 
EQUIPMENT 

I don't have a copy of these standards, but they should relate to this issue.

With regard to a general discusion of this subject, have a look at the 
Rationale section (Appendix A) of IEC 60601-1. The rationale on 
sub-clause 19.3 gives information, a graph and references on this subject.

Regards,

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



--- Forwarded message follows ---
Hi all

I have a medical device under EU directive 93/42/EEC. It is a class IIa
product and sends some small electrical pulses through the body for
treatments.

Does anyone know of any limit for the current ? (voltage is generated
from battery and is max. 16Vdc)

Does anyone have the current/frequency diagram over max. current the the
body can withstand without hazards ? (It is normally used for mains
leakage current protection).


Best regards,

Kim Boll Jensen
Bolls Raadgivning
Denmark

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(Fwd) RE: Creepage on PCB Internal Layers

2002-08-14 Thread jgriver

Chris,

I know I may be stating the obvious, but creepage and clearance distances do 
not apply on inner layers of void free PCB's BY 
DEFINITION.

If you refer to clauses 1.2.10.1 and 1.2.10.2 in IEC 60950 or 3.6.7 and 3.6.8 
of IEC 61010-1, clearance is defined as distance in air 
between two conductive parts, while creepage is the shortest distance along the 
surface of the insulating material between two 
conductive parts.

You are looking for distance through insulation.

Regards,

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



Yes,  Thanks Richard 

By the way...Rich Woods...Tektronics (Richard Payne's company) also makes fiber 
optic power meters.   Sorry that I forgot to 
mention them in my reply earlier today.  Yes, they're a competitor of ours; but 
their compliance guy is nice enough to answer my 
questions :-)
**
Now back to the issue at hand.

That's what I was looking for (the statement in paragraph 6.7 of EN 61010-1)  
The copy that I have has the amendments separate.  
I found it in Amendment 2 as you stated.

To me, it's sort of funny in that it just says that the Creepage and Clearance 
distances do not apply on inner layers of void free PCBs. 
  That's nice; but I can't find where a distance is specified.  I mean, I would 
think that there should be some minimum distance 
between an AC line and a 5V SELV line on an inner layer of the board

Our layout guy has a military specification that specifies insulation for 
300-500V circuits.  It specifies .100 on external layers and 
.010 on internal layers...which would work out to a factor of 10 reduction 
between surface layers and inner layers.

Using that same reasoning, I was looking at a circuit that needs 8mm of 
creepage on a surface layer (.314).   Would I be safe in 
allowing 0.8mm (0.0314) of distance on an inner layer?

Anybody have any thoughts on this one.

Chris Maxwell | Design Engineer - Optical Division
email chris.maxw...@nettest.com | dir +1 315 266 5128 | fax +1 315 797 8024

NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA
web www.nettest.com | tel +1 315 797 4449 | 




 -Original Message-
 From: richard.pa...@exgate.tek.com [SMTP:richard.pa...@exgate.tek.com]
 Sent: Tuesday, August 13, 2002 3:17 PM
 To:   Chris Maxwell; emc-p...@majordomo.ieee.org
 Subject:  RE: Creepage on PCB Internal Layers
 
 Hi Chris:
 
 The 2nd edition of 61010 has the statement in clause 6.7:
 
 There are no CLEARANCE or CREEPAGE DISTANCE requirements for the interior of
 void-free moulded parts, including the inner layers of multi-layer printed
 circuit boards.
 
 
 UL3111 has the following UL deviation from the 1st edition of 61010:
 
 6.7 Eliminate spacing requirements on inner layers of multi-layer printed
 circuit boards
 
 The inner layers of a multilayer printed circuit board are considered to be
 void-free molded parts. The CLEARANCES and CREEPAGE DISTANCES specified in
 Annex D do not apply to these inner layers.  (See Note 2 of Annex D,
 subclause D.2.1 of Amendment 1).
 
 Richard
 
 Richard Payne
 Tektronix Inc.
 Product Safety Engineering
 V: (503) 627-1820
 F: (503) 627-3838
 E: richard.pa...@tektronix.com
 
 

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EMC/EMI/ESD Requirements for Medical Electronics in US?

2002-08-10 Thread jgriver

John,

In the United States, the FDA regulates medical devices. The following link 
will gives you information on the FDA's approach to EMC:

http://www.fda.gov/cdrh/emc/

Although IEC 60601-1-2 is a 'concensus standard', FDA investigators sometimes 
have different or additional requirements. I have even 
known cases of demands for compliance with military immunity standards. The FDA 
writes the following:

This standard should serve as a baseline for all of the appropriate device 
areas. However, where there are existing CDRH guidance 
documents with additional EMC specifications then these will supersede the 
basic IEC requirements. 

Note that you will need UL 2601-1, but for product safety, not EMC. The 
reference to electrostatic charges in clause 39.3, which you 
found, is in regard to the risk of explosion of anaesthetic gases! This 
standard, or the international version, IEC 60601-1, covers 
electrical, mechanical and other safety aspects of medical electrical products.

You may also find EMC requirements in the standards for particular types of 
medical equipment. These are numbered IEC 60601-2-
XX, and you can see a list of them at:

http://www.601help.com/Other_601_Standards/other_601_standards.html

These EMC requirements may amend the requirements in IEC 60601-1-2 and will 
always be in clause 36 of these standards.

Also note that in the US, medical equipment which intentionally uses EM 
radiation (e.g. microwave therapy devices), as well as 
ultrasound equipment, is required to comply with FCC Part 18, for ISM equipment.


For the European Union, the EMC requirements are EN 60601-1-2, plus any EMC 
requirements of EN 60601-2-XX. (The EN version is 
usually almost identical to the IEC version). However, you should note that at 
the moment the 1993 version of the standard is in 
effect, not the 2001 version! Presumably the 2001 version will come into effect 
at some point in the future. You can see a list of all the 
Medical Device Directive harmonised standards at:

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

(If this wraps to two lines, you may have to enter the second line manually)

A further note about IEC or EN 60601-1-2. It is a 'pointing' standard, in that 
it refers to and provides test levels for EN 55011 for 
emissions and IEC 61000-4-X for immunity. These latter standards basically 
provide test methods for different EMC phenomena.


Regards,


Jon Griver
www.601help.com
The Medical Device Designer's Guide to IEC 60601-1



EMC-PSTC'ers,
Does the United States have any electromagnetic compatibility (EMC),
electromagnetic interference (EMI), or electrostatic discharge (ESD)
standards for medical electronics?  If so, where can I find them?

A prospective client has asked about EMC/EMI/ESD testing for a wearable
medical-monitor.  It looks like the applicable standards for Europe are:
*  EN 55011:1998 +Amendment A1:1999.
*  EN 60601-1-2:2001.

I found some references on the Internet to:
*  The Food and Drug Administration using UL 2601-1 for medical 
   devices.
*  UL 2601-1 having the same immunity requirements as EN 60601-1-2.

Having been bitten by supposedly-identical standards being just a little
different in areas critical to products I've designed, we bought
UL2601-1 ($155 with shipping and handling), and received it yesterday. 
The cover letter is dated June 16,2000, and describes it as Second
Edition, Dated October 24, 1997.

Section 39.2 has a couple of paragraphs about Prevention of
electrostatic charges.  

Appendix A1, section A1.5.2, says The sensitivity of EQUIPMENT to
external interference (electromagnetic field, perturbations of the
supply voltage) is under consideration.

Appendix L refers to IEC 601-1-2:1993.

Is there a newer amendment to UL 2601-1 that has EMC/EMI/ESD
requirements, or just what *do* people use to verify/certify medical
electronics?

Thanks!
John Barnes
dBi Corporation
http://www.dbicorporation.com/

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(Fwd) TOUCH CURRENT LIMIT

2002-06-24 Thread jgriver

Dear Xing weibing,

I can't give you a direct answer to your questions, but you may find the 
discussion in sub-clause 19.3 of the General Guidance and 
Rationale in IEC 60601-1 (Electrical Medical Equipment) of interest. There is 
information on the effect of electrical currents on the 
human body, as well as a list of references.

Regards,

Jon Griver
www.601help.com
The Medical Device Developers Guide to IEC 60601-1


--- Forwarded message follows ---
Dear colleagues

I have a question regarding touch current limit of IEC 60950?

We can read from table 5A of IEC60950:1999:

Touch current limit for accessible parts and circuits not connected 

to protective earth: 0.25 mA

question 1 : How does it (0.25mA) come from and what  it is based on?

based on IEC479? OR other source
why it is not 0.5mA(based on IEC60479)

question 2 :for hand-held equipment it is 0.75mA
why ?

Please shed some light for above questions


Any comments are appreciated

Best Regards


Xing weibing

2002-06-24
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(Fwd) RE: Safety Overview Web Site

2002-05-31 Thread jgriver

Reginald, Peter,

Discovered at last!! Yes I admit that I set up and run both i-spec and 601help. 
I manage i-spec on behalf of ITL, while 601help is my 
own site.

Although the sites are not intended for 'professionaIs', but more for design 
engineers who are not that knowledgeable on compliance 
issues, I hope that group members also find them useful. I would like to take 
this opportunity to ask group members for any 
suggestions they may have to improve these sites.

I should point out that these sites are a 'labour of love', as I do not derive 
significant income from them.

Regards,

Jon Griver
www.i-spec.com
www.601help.com


--- Forwarded message follows ---
From:   Peter Tarver peter.tar...@sanmina-sci.com
To: Reginald Henry rhe...@vicon-cctv.com,
EMC PSTC (E-mail) emc-p...@majordomo.ieee.org
Subject:RE: Safety Overview Web Site
Date sent:  Thu, 30 May 2002 10:49:45 -0700
Send reply to:  Peter Tarver peter.tar...@sanmina-sci.com


Also FYI:


Domain Name: I-SPEC.COM
Registrar: NETWORK SOLUTIONS, INC.
Whois Server: whois.networksolutions.com
ITL (Product Testing) Ltd.
POB 211
Or Yehuda
60251
IL
Administrative Contact, Technical Contact: Griver, Jon

Perhaps the same Jon Griver of 601help.com: 

Powerful Connections Ltd.
Rehov HaGoren 13
Gedera, Not USA 70700
Israel


A contributor to this list.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com

 -Original Message-
 From: Reginald Henry
 Sent: Thursday, May 30, 2002 7:54 AM
 
 FYI,
 
 http://www.i-spec.com/IEC_60950/index_to_iec_60950.html
 
 
 I have found this site to be a good overview for 
 safety issues
 
 RH
 

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Re: non 601 approved isolating component

2002-05-02 Thread jgriver

Ron,

In answer to your questions:

1) Let's assume that the component fully complies with IEC 60601-1. 
Unfortunately, the way tests labs will relate to this situation will 
depend on the lab's own internal procedures. The main concern is the level of 
control you have over the changes in the specification of 
the isolating device. Theoretically the component manufacturer could change the 
spec without changing the model number and 
without informing you. Practically, I believe that most test labs would accept 
this situation if there was a written commitment from the 
component manufacturer to inform you if there are any changes made.

2) If the isolating device is embedded in epoxy, then the test lab probably 
would not require the schematics of the device. If not, they 
would need the schematics in order to evaluate creepages and clearances.

3) Approval to another standard does not help, as the manufacturer of the 
component could make a change that would cause the 
component to no longer comply with IEC 60601-1, while still complying with its 
approval to the other standard.

In short, you should liase with your chosen test lab on this issue.

Regards,

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




On 1 May 2002 at 14:49, Ron wrote:

 
 
 I need to use an isolating device between a sip/sop and an applied
 part (BF) requiring 1500V isolation (Basic(250)).  I plan on using a
 digital isolator, but the component does not have IEC601 approval. 
 The component does have 2500V isolation and 8 mm creepage.
 
 Questions:
 
 1) When our product is submitted for IEC601 certification, how does
 the use of the non 601 approved part affect the investigation?
 
  2) Does the investigator need the schematic for that component?  What
  if
 the schematic is not available?
 
  3) If the component already has other approvals (UL1950 or UL1577). 
  How
 does this affect the approval process?
 
 Thanks in advance.
 
 r...@vascor.com
 
 
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