Leo,  

 

                The requirements in 62368-1 are supported by the rationale
document 62368-2 which more fully explains the basis for the requirements in
the standard.  It has been put together to help standards committees - such
as yours - understand these.  

 

                There was an early on comparison between 60950 and 62368
(already discussed here) which could be generally helpful but has not been
kept up to the latest changes.   

 

                The ongoing intent in 62368-1 has been to ensure that
present practices should be acceptable under the new standard as long as
they meet the requirements of the new standard.  

 

                Most generally it probably can be assumed that they provide
equivalent safety protection under each standard (altho there are some
significant differences - e.g. the 10 or 100 uA touch current limits in
60601-1 which are lower than the allowed limits of 0.5 and 5mA in 62368-1);
so it may not immediately fall out from some simple discussion since there
are many details in each standard which need to be compared unless you
accept the general assumption. 

 

                TC108 is still struggling with the issues surrounding moving
from 60950 to 62368 details, such as how to accept components designed to
60950 in the context of the new standard.  TC108 has, in the past, invoked
additional requirements on components when it appeared that the component
standard did not meet the expected requirements of the standard.  It is not
unreasonable to do so again.  Altho TC108 has worked with SC22E on their Low
Voltage Switch Mode Power Supplies safety standard, IEC 61207-7, and have
achieved considerable harmonization in the requirements the inclusion of
that as a normative standard within 62368-1 certification is not yet
automatically accepted; awaiting the outcome of the related issues discussed
here.  

 

                SC62A should request to work with TC108 in your process of
review and change.  This probably won't work out for this week's meeting but
should provide you with a path to understanding how to incorporate these
devices in your medical systems.  

 

                Good luck in working thru all of this.  

  

:>)     br,      Pete

 

Peter E Perkins, PE

Principal Product Safety & Regulatory Affairs Consultant

PO Box 23427

Tigard, ORe  97281-3427

 

503/452-1201

 

 <mailto:p.perk...@ieee.org> p.perk...@ieee.org

 

From: Leo Eisner [mailto:l...@eisnersafety.com] 
Sent: Tuesday, December 5, 2017 4:40 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Was there ever a comparison between IEC 60950-1 and IEC
62368-1 (current edition preferable)? And any rationale for any of the
changes

 

I am in IEC SC62A (60601-1 series of standards - Medical electrical
equipment & systems) meetings this week and we are trying to id the
differences between these 2 standards so we can figure out how to integrate
IEC 62368-1 into IEC 60601-1, 3rd ed. + A2, if we have the time and
agreement with the National Committees is to be determined. We are working
on A2 currently (at CD1 stage) and initially we decided not to include IEC
62368-1 in the A2 but wait for 4th ed. but that likely may be too late for
power supplies as 60950 is ending in a couple years for at least EU.

 

Thx all,

 

        
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants

Phone:  <tel:(503)%20244-6151> (503) 244-6151

Mobile:  <tel:(503)%20709-8328> (503) 709-8328

Email:  <mailto:l...@eisnersafety.com> l...@eisnersafety.com

Website:  <http://www.eisnersafety.com/> 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.

****************************************************************************
***

 

-
----------------------------------------------------------------

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 <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 <sdoug...@ieee.org <mailto:sdoug...@ieee.org> >
Mike Cantwell <mcantw...@ieee.org <mailto:mcantw...@ieee.org> > 

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

Reply via email to