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
>
>
> -
> 
>
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-- 
//
Patrick

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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 
>

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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] 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:
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Attachments are not permitted but the IEEE PSES Online Communities site at 
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formats), large files, etc.

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Jim Bacher:  
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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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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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