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


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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

-

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[PSES] Electronic Products used in Automotive Compliance

[Sam Yogasuntharam]

Team,

Do you know if there are special rules/certifications required in the USA to 
install Electronic Products in cars (bus)?
And if so, what will be the standard?


Sam Yoga
Crestron Electronics



This e-mail message and all attachments transmitted with it may contain legally 
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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


-


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discussion list. To post a message to the list, send your e-mail to 
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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.
-


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Re: [PSES] Electronic Products used in Automotive Compliance

[Brian O'Connell]

'Cars' and 'busses' are two different regulatory subjects. Requirements 
standards can range from nothing to ISO 26262 (nee IEC61508); and from nothing 
to CISPR25/VCA for EMC.

And happen to know that Crestron has, or did have, more than one compliance 
engineer. Your local compliance engineer should be showered with affection and 
adoration prior to any questions. A presentation of donuts and coffee are 
typically agreeable to regulatory people.

Brian

From: Sam Yogasuntharam [mailto:sy...@crestron.com] 
Sent: Monday, November 30, 2015 1:13 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Electronic Products used in Automotive Compliance

Team,

Do you know if there are special rules/certifications required in the USA to 
install Electronic Products in cars (bus)?
And if so, what will be the standard?


Sam Yoga
Crestron Electronics

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[PSES] Cable retention force

[Gary McInturff]

Does anybody know of a standard which describes cable retention force other 
than safety standards such as 60601-1 (Medical General Safety) or 60950 (ITE 
general safety) and if so can you give me the numbers. The product is about 2 
pounds. ITE would say that the value is about 6 pounds.

-

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Re: [PSES] New LV Directive 2014/35/EU

[Charlie Blackham]

Scott

There is a recently published draft guidance document on this Directive that 
may address some of your questions:
http://ec.europa.eu/DocsRoom/documents/13141/attachments/1/translations/en/renditions/pdf
 

regards
Charlie

-Original Message-
From: Scott Xe [mailto:scott...@gmail.com] 
Sent: 30 November 2015 13:47
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] New LV Directive 2014/35/EU

There are 3 additional requirements as compared with existing one.

The technical documentation shall include an adequate analysis and assessment 
of the risk(s).  What is objective and scope for these?  Do these analysis and 
assessment refer to 3rd party verification of compliance with applicable 
standard(s) or are they on top of compliance with applicable safety standard(s)?

In DoC, a suitable identification of the product should be included - a colour 
image of the product could be employed.  Is there any guideline for this 
product image?  One exterior front view photo like one on front cover of 
catalogue or a series of different views of the product?

Article 6, point 4 regarding manufacturers’ obligations, to protect the health 
and safety of consumers, carry out sample testing of electrical equipment made 
available on the market.  Does it mean the sample testing, i.e.. dielectric 
strength test, earth continuity test, etc. is taken in production at factory or 
in warehouse of destined market?

Your guidance is highly appreciated!

Regards,

Scott

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Re: [PSES] New LV Directive 2014/35/EU

[Kunde, Brian]

Scott,

The New LVD as with the latest Machinery Directive requires a Risk Assessment 
of the Essential Health and Safety Requirements called out in the Directive. 
Most likely the new ISO EN 12100 Risk Assessment standard will be harmonized to 
the LVD and you can use this on your DoCs to show compliance for safety in 
additional to any other applicable safety standards.  The world of product 
safety is changing from a list of do's and don't found in product safety 
standards to a proper Risk Assessment of your products. There are several good 
articles out there on this topic.

The color image is optional. I'm curious to see how many manufacturers include 
color images and how they implement them on DoCs.  I think this was added 
because in some cases there may be items that cannot be properly identified by 
other means in which case the color image may be required. I think the only 
requirement of the image is that it must show the product in a way where it can 
be properly identified from other products if you are relying on the image for 
that purpose.

Regarding sample testing, I'm not sure. This could refer the 100% type testing 
performed in Production, which you should already be doing. Or it could refer 
to actual product audits, which I am highly in favor of but many companies do 
not bother with; except for the factory inspections performed by 3rd party 
certification houses. If and how you do sample testing of production to insure 
you are shipping compliant products will vary from company to company depending 
on many factors and can only really be determined by the manufacturer.

I hope this was helpful.

The Other Brian

-Original Message-
From: Scott Xe [mailto:scott...@gmail.com]
Sent: Monday, November 30, 2015 8:47 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] New LV Directive 2014/35/EU

There are 3 additional requirements as compared with existing one.

The technical documentation shall include an adequate analysis and assessment 
of the risk(s).  What is objective and scope for these?  Do these analysis and 
assessment refer to 3rd party verification of compliance with applicable 
standard(s) or are they on top of compliance with applicable safety standard(s)?

In DoC, a suitable identification of the product should be included - a colour 
image of the product could be employed.  Is there any guideline for this 
product image?  One exterior front view photo like one on front cover of 
catalogue or a series of different views of the product?

Article 6, point 4 regarding manufacturers’ obligations, to protect the health 
and safety of consumers, carry out sample testing of electrical equipment made 
available on the market.  Does it mean the sample testing, i.e.. dielectric 
strength test, earth continuity test, etc. is taken in production at factory or 
in warehouse of destined market?

Your guidance is highly appreciated!

Regards,

Scott

-

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discussion list. To post a message to the list, send your e-mail to 


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Jim Bacher:  
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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.

-

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Re: [PSES] New LV Directive 2014/35/EU

[Ted Eckert]

A color photograph has been a requirement of the Toy Directive for a long time. 
However, toys are different than most other products. If customs receives a 
shipment of toy cars of model X from company Y, it can be difficult to 
determine if what is in the box is what is declared on the DoC. The product may 
have labeling or packaging clearly identifying it, but it may not. The 
photograph is an important tool for market surveillance. This requirement was 
added to the draft NLF Directives for a similar purpose. However, the issue is 
different with other types of products, particularly with highly specialize 
equipment where a DoC may cover a series of products that differ significantly 
in appearance depending on the configuration of components. The result was that 
the photograph was made an option. I would recommend it for products where it 
can be difficult to clearly identify the model and manufacturer. However, this 
won't apply to most technology products.

The routine testing depends on the product type, but it would be the EN 50514 
testing for products falling under EN 60950-1. The standard only requires 
routine testing for some components types and for some conditions to allow 
reduced spacings and such. However, it doesn't specify routine testing at the 
system level. I believe that the current list of standards harmonized under the 
Low Voltage Directive includes some routine testing standards, such as EN 50106 
for household and similar electrical appliances. However, it does not include 
EN 50514, so routine testing would not be required if you were to declare the 
presumption of conformity through the standards route. If your product is 
certified, the certification agency may require routine testing, but 
certification isn't mandatory. For ITE, I believe you could self-declare 
compliance without routine testing. The new LVD is intended to change that.

Disclaimer: I do not have extensive knowledge of the development of the new LVD 
and what I stated may be incorrect. Take it as guidance only and not 
necessarily as hard fact. I would encourage anybody with better insight to 
correct my statements where they are wrong.

Ted Eckert
Compliance Engineer
Microsoft Corporation
ted.eck...@microsoft.com

The opinions expressed are my own and do not necessarily reflect those of my 
employer.

-Original Message-
From: Kunde, Brian [mailto:brian_ku...@lecotc.com] 
Sent: Monday, November 30, 2015 7:27 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] New LV Directive 2014/35/EU

Scott,

The New LVD as with the latest Machinery Directive requires a Risk Assessment 
of the Essential Health and Safety Requirements called out in the Directive. 
Most likely the new ISO EN 12100 Risk Assessment standard will be harmonized to 
the LVD and you can use this on your DoCs to show compliance for safety in 
additional to any other applicable safety standards.  The world of product 
safety is changing from a list of do's and don't found in product safety 
standards to a proper Risk Assessment of your products. There are several good 
articles out there on this topic.

The color image is optional. I'm curious to see how many manufacturers include 
color images and how they implement them on DoCs.  I think this was added 
because in some cases there may be items that cannot be properly identified by 
other means in which case the color image may be required. I think the only 
requirement of the image is that it must show the product in a way where it can 
be properly identified from other products if you are relying on the image for 
that purpose.

Regarding sample testing, I'm not sure. This could refer the 100% type testing 
performed in Production, which you should already be doing. Or it could refer 
to actual product audits, which I am highly in favor of but many companies do 
not bother with; except for the factory inspections performed by 3rd party 
certification houses. If and how you do sample testing of production to insure 
you are shipping compliant products will vary from company to company depending 
on many factors and can only really be determined by the manufacturer.

I hope this was helpful.

The Other Brian

-Original Message-
From: Scott Xe [mailto:scott...@gmail.com]
Sent: Monday, November 30, 2015 8:47 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] New LV Directive 2014/35/EU

There are 3 additional requirements as compared with existing one.

The technical documentation shall include an adequate analysis and assessment 
of the risk(s).  What is objective and scope for these?  Do these analysis and 
assessment refer to 3rd party verification of compliance with applicable 
standard(s) or are they on top of compliance with applicable safety standard(s)?

In DoC, a suitable identification of the product should be included - a colour 
image of the product could be employed.  Is there any guideline for this 
product image?  One exterior front view photo like one on front 

Re: [PSES] Cable retention force

[Brian Gregory]

  UL 508A refers us to UL 310 for bushings;  UL 486A-486B Table 27 has values 
for #30 up to 2000 kCM, but that is only based on cable size, not the weight of 
equipment.  My non-indexed search didn't come up with anything else through a 
dozen or so IEC standards while searching for "retention" or "pullout."  
Interesting challenge.  You might try ASME standards on the bushings. Colorado 
Brian 
720-450-4933

-- Original Message --
From: Gary McInturff 
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Cable retention force
Date: Mon, 30 Nov 2015 17:04:38 +


Does anybody know of a standard which describes cable retention force other 
than safety standards such as 60601-1 (Medical General Safety) or 60950 (ITE 
general safety) and if so can you give me the numbers. The product is about 2 
pounds. ITE would say that the value is about 6 pounds.
-
 
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[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



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Re: [PSES] New LV Directive 2014/35/EU

[Scott Xe]

Hi Charlie,

It is a good reference guidance!  Thanks!

Regards,

Scott

On 30 November 2015 at 23:08, Charlie Blackham  wrote:

> Scott
>
> There is a recently published draft guidance document on this Directive
> that may address some of your questions:
>
> http://ec.europa.eu/DocsRoom/documents/13141/attachments/1/translations/en/renditions/pdf
>
> regards
> Charlie
>
> -Original Message-
> From: Scott Xe [mailto:scott...@gmail.com]
> Sent: 30 November 2015 13:47
> To: EMC-PSTC@LISTSERV.IEEE.ORG
> Subject: [PSES] New LV Directive 2014/35/EU
>
> There are 3 additional requirements as compared with existing one.
>
> The technical documentation shall include an adequate analysis and
> assessment of the risk(s).  What is objective and scope for these?  Do
> these analysis and assessment refer to 3rd party verification of compliance
> with applicable standard(s) or are they on top of compliance with
> applicable safety standard(s)?
>
> In DoC, a suitable identification of the product should be included - a
> colour image of the product could be employed.  Is there any guideline for
> this product image?  One exterior front view photo like one on front cover
> of catalogue or a series of different views of the product?
>
> Article 6, point 4 regarding manufacturers’ obligations, to protect the
> health and safety of consumers, carry out sample testing of electrical
> equipment made available on the market.  Does it mean the sample testing,
> i.e.. dielectric strength test, earth continuity test, etc. is taken in
> production at factory or in warehouse of destined market?
>
> Your guidance is highly appreciated!
>
> Regards,
>
> Scott
>
> -
> 
> 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.
>
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> Mike Cantwell 
>
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>

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This message is from the IEEE Product Safety Engineering Society emc-pstc 
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formats), large files, etc.

Website:  http://www.ieee-pses.org/
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[PSES] New LV Directive 2014/35/EU

[Scott Xe]

There are 3 additional requirements as compared with existing one.

The technical documentation shall include an adequate analysis and assessment 
of the risk(s).  What is objective and scope for these?  Do these analysis and 
assessment refer to 3rd party verification of compliance with applicable 
standard(s) or are they on top of compliance with applicable safety standard(s)?

In DoC, a suitable identification of the product should be included - a colour 
image of the product could be employed.  Is there any guideline for this 
product image?  One exterior front view photo like one on front cover of 
catalogue or a series of different views of the product?

Article 6, point 4 regarding manufacturers’ obligations, to protect the health 
and safety of consumers, carry out sample testing of electrical equipment made 
available on the market.  Does it mean the sample testing, i.e.. dielectric 
strength test, earth continuity test, etc. is taken in production at factory or 
in warehouse of destined market?

Your guidance is highly appreciated!

Regards,

Scott

-

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:
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Mike Cantwell 

For policy questions, send mail to:
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