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 <tel:(503) 244-6151>
Mobile: (503) 709-8328 <tel:(503) 709-8328>
Email: [email protected] <mailto:[email protected]>
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 <[email protected]> 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 : [email protected] <mailto:[email protected]>/[email protected].
>> <mailto:[email protected]>
>>
>>
>>
>>
>>
>> -
>> ----------------------------------------------------------------
>> 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
>> <[email protected] <mailto:[email protected]>>
>>
>> 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 <[email protected] <mailto:[email protected]>>
>> Mike Cantwell <[email protected] <mailto:[email protected]>>
>>
>> For policy questions, send mail to:
>> Jim Bacher <[email protected] <mailto:[email protected]>>
>> David Heald <[email protected] <mailto:[email protected]>>
>>
> -
> ----------------------------------------------------------------
> 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
> <[email protected] <mailto:[email protected]>>
>
> 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 <[email protected] <mailto:[email protected]>>
> Mike Cantwell <[email protected] <mailto:[email protected]>>
>
> For policy questions, send mail to:
> Jim Bacher <[email protected] <mailto:[email protected]>>
> David Heald <[email protected] <mailto:[email protected]>>
>
-
----------------------------------------------------------------
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
<[email protected]>
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 <[email protected]>
Mike Cantwell <[email protected]>
For policy questions, send mail to:
Jim Bacher: <[email protected]>
David Heald: <[email protected]>
