Re: [PSES] Fwd: [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

2017-12-07 Thread Pete Perkins 
Leo,

 

They should make you the convenor of the group to harmonize 
upgrading the requirements between 60601 and 62368 since you know how to get 
input in a hurry.  :>)

 

:>) br,  Pete

 

Peter E Perkins, PE

Principal Product Safety & Regulatory Affairs Consultant

PO Box 23427

Tigard, ORe  97281-3427

 

503/452-1201

 

  p.perk...@ieee.org

 

PS:  please remove the graphic elements from your sig block, the 
EMC-PSTC server rejects the replies which include them.  

 

From: Leo Eisner [mailto:l...@eisnersafety.com] 
Sent: Thursday, December 7, 2017 11:11 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Fwd: [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

 

It seems like my e-mail response got bounced so I am sending again.  Apologies 
if a duplicate.

 

Thx to all your feedback and I clearly get the point these are very different 
standards but changing from using bits and pieces of IEC 60950-1 to IEC 62368-1 
in our draft IEC 60601-1, 3rd ed. + A2 and not knowing the IEC 62368-1 well 
(obviously as I am a 60601-1 expert) I was just doing a favor for the Chairmans 
Advisory Group (CAG SC 62A) that I am not part of but to help them have a quick 
answer - which is not practicable as I see now the Elephant and the plum don’t 
fit together.

 

Ted - I didn’t know you were that oldd!!! :)

 

Thx all and I will pass on the comments and some of the humor to my CAG.

 

Cheers,

 


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

Phone:   (503) 244-6151

Mobile:   (503) 709-8328

Email:   l...@eisnersafety.com

Website:   www.EisnerSafety.com



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[PSES] Fwd: [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

2017-12-07 Thread Leo Eisner 
It seems like my e-mail response got bounced so I am sending again.  Apologies 
if a duplicate.
> 
> Thx to all your feedback and I clearly get the point these are very different 
> standards but changing from using bits and pieces of IEC 60950-1 to IEC 
> 62368-1 in our draft IEC 60601-1, 3rd ed. + A2 and not knowing the IEC 
> 62368-1 well (obviously as I am a 60601-1 expert) I was just doing a favor 
> for the Chairmans Advisory Group (CAG SC 62A) that I am not part of but to 
> help them have a quick answer - which is not practicable as I see now the 
> Elephant and the plum don’t fit together.
> 
> Ted - I didn’t know you were that oldd!!! :)
> 
> Thx all and I will pass on the comments and some of the humor to my CAG.
> 
> Cheers,
> 
> 
>   Leonard (Leo) Eisner, P.E.
> Principal Consultant, Eisner Safety Consultants
> Phone: (503) 244-6151 
> Mobile: (503) 709-8328 
> Email: l...@eisnersafety.com 
> Website: 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 
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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 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

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Re: [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

2017-12-06 Thread Brian O'Connell 
The ISO and IEC should develop and publish the rationale along with the release 
of the standard itself. Avoid forcing the data fit an existent conjecture. 
ANSI, SCC, CENELEC, etc should never harmonize a new standard without the 
engineering rationale.



As for a comparative tabulations - they are suitable tools, but they may foment 
a poor mindset that results in a gap analysis that does nothing to promulgate 
or ensure the 'new way' intended by stuff such as 3d ed 60601-1 and 62368-1.



Brian
My opinions do not necessarily reflect the policies or intent of the Klingon 
Emperor. Long live the Empire. And my employer tends to absolve themselves of 
my public statements


From: Ted Eckert [mailto:07cf6ebeab9d-dmarc-requ...@ieee.org]
Sent: Wednesday, December 06, 2017 1:50 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [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

It appears that my copy of 60950-1 is a bit old. It was hand written on a 
vellum scroll. My company antiquities director prohibits me from cutting off a 
piece for spectrographic analysis.

Ted Eckert
Microsoft Corporation

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

From: John Woodgate [mailto:j...@woodjohn.uk]
Sent: Wednesday, December 6, 2017 12:55 PM
To: Ted Eckert >; 
EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [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


And if you print the standards, they are both made of paper. But it doesn't 
help. Steep learning curve!

John Woodgate OOO-Own Opinions Only

J M Woodgate and Associates 
www.woodjohn.uk

Rayleigh, Essex UK
On 2017-12-06 19:48, Ted Eckert wrote:
A spectrographic analysis of a plum and coconut might find them to be quite 
similar.
https://www.improbable.com/airchives/paperair/volume1/v1i3/air-1-3-apples.html

Ted Eckert
Microsoft Corporation

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

From: Doug Powell [mailto:doug...@gmail.com]
Sent: Wednesday, December 6, 2017 11:32 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [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

Back in the day, the question was asked: "What's the difference between an 
elephant and a plum?"  Answer: "They're exactly the same, except the elephant."




On Wed, Dec 6, 2017 at 12:19 PM, Pete Perkins 
<0061f3f32d0c-dmarc-requ...@ieee.org>
 wrote:
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

Re: [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

2017-12-06 Thread Ted Eckert 
It appears that my copy of 60950-1 is a bit old. It was hand written on a 
vellum scroll. My company antiquities director prohibits me from cutting off a 
piece for spectrographic analysis.

Ted Eckert
Microsoft Corporation

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

From: John Woodgate [mailto:j...@woodjohn.uk]
Sent: Wednesday, December 6, 2017 12:55 PM
To: Ted Eckert ; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [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


And if you print the standards, they are both made of paper. But it doesn't 
help. Steep learning curve!

John Woodgate OOO-Own Opinions Only

J M Woodgate and Associates 
www.woodjohn.uk

Rayleigh, Essex UK
On 2017-12-06 19:48, Ted Eckert wrote:
A spectrographic analysis of a plum and coconut might find them to be quite 
similar.
https://www.improbable.com/airchives/paperair/volume1/v1i3/air-1-3-apples.html

Ted Eckert
Microsoft Corporation

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

From: Doug Powell [mailto:doug...@gmail.com]
Sent: Wednesday, December 6, 2017 11:32 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [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

Back in the day, the question was asked: "What's the difference between an 
elephant and a plum?"  Answer: "They're exactly the same, except the elephant."




On Wed, Dec 6, 2017 at 12:19 PM, Pete Perkins 
<0061f3f32d0c-dmarc-requ...@ieee.org>
 wrote:
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

p.perk...@ieee.org

From: Leo Eisner [mailto:l...@eisnersafety.com]
Sent: Tuesday, December 5, 2017 4:40 PM
To:

Re: [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

2017-12-06 Thread John Woodgate 
And if you print the standards, they are both made of paper. But it 
doesn't help. Steep learning curve!


John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK

On 2017-12-06 19:48, Ted Eckert wrote:


A spectrographic analysis of a plum and coconut might find them to be 
quite similar.


https://www.improbable.com/airchives/paperair/volume1/v1i3/air-1-3-apples.html

Ted Eckert

Microsoft Corporation

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


*From:* Doug Powell [mailto:doug...@gmail.com]
*Sent:* Wednesday, December 6, 2017 11:32 AM
*To:* EMC-PSTC@LISTSERV.IEEE.ORG
*Subject:* Re: [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


Back in the day, the question was asked: "What's the difference 
between an elephant and a plum?"  Answer: "They're exactly the same, 
except the elephant."


On Wed, Dec 6, 2017 at 12:19 PM, Pete Perkins 
<0061f3f32d0c-dmarc-requ...@ieee.org 
> wrote:


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 

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: (503) 244-6151 

Mobile: (503) 709-8328 

Email: l...@eisnersafety.com 

Website: www.EisnerSafety.com

Re: [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

2017-12-06 Thread Ted Eckert 
A spectrographic analysis of a plum and coconut might find them to be quite 
similar.
https://www.improbable.com/airchives/paperair/volume1/v1i3/air-1-3-apples.html

Ted Eckert
Microsoft Corporation

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

From: Doug Powell [mailto:doug...@gmail.com]
Sent: Wednesday, December 6, 2017 11:32 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [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

Back in the day, the question was asked: "What's the difference between an 
elephant and a plum?"  Answer: "They're exactly the same, except the elephant."




On Wed, Dec 6, 2017 at 12:19 PM, Pete Perkins 
<0061f3f32d0c-dmarc-requ...@ieee.org>
 wrote:
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

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: (503) 244-6151
Mobile: (503) 709-8328
Email: l...@eisnersafety.com
Website: 
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,

Re: [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

2017-12-06 Thread Doug Powell 
Back in the day, the question was asked: "What's the difference between an
elephant and a plum?"  Answer: "They're exactly the same, except the
elephant."




On Wed, Dec 6, 2017 at 12:19 PM, Pete Perkins <
0061f3f32d0c-dmarc-requ...@ieee.org> wrote:

> 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 <(503)%20452-1201>
>
>
>
> 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: (503) 244-6151
>
> Mobile: (503) 709-8328
>
> Email: l...@eisnersafety.com
>
> Website: www.EisnerSafety.com 
>
> *** Internet E-mail Confidentiality Disclaimer ***
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> 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
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Re: [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

2017-12-06 Thread Pete Perkins 
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

 

  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:   (503) 244-6151

Mobile:   (503) 709-8328

Email:   l...@eisnersafety.com

Website:   www.EisnerSafety.com



*** Internet E-mail Confidentiality Disclaimer ***

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received this e-mail message in error, please return by forwarding the
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Eisner Safety Consultants do not accept liability for any errors, omissions,
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Re: [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

2017-12-06 Thread JIM WIESE 
The short answer is they are about the same as a coconut and a plum, 
particularly in regards to telecommunications criteria (Now called ES1, ES2, 
ES3, ID#'s, and communications circuits, not SELV and TNV anymore), gets worse 
once 62368-3 is published in a few months.


Jim Wiese
Senior Compliance Engineer

Office: 256.963.8431
Mobile: 256.714.5882
Email: jim.wi...@adtran.com
Web: www.adtran.com

ADTRAN
901 Explorer Boulevard
Huntsville, AL 35806 - USA

ADTRAN, INC.

From: John Woodgate [mailto:j...@woodjohn.uk]
Sent: Wednesday, December 06, 2017 2:05 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [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


Re 'rationale', there is some information in Clause 0 of 62368-1 and in IEC 
62368-2. But 60950-1 and 62368-1 are fundamentally different, because most of 
the provisions of 60950-1 were derived from experience and ad-hoc reasoning  
but those of 62368-1 are derived from structured reasoning ('hazard-based 
standard').  Of course, experience and reasoning came to the same conclusion in 
some cases.

The 3rd edition of 62368-1 has most of the bugs removed. The 4th edition will, 
everyone hopes, not be very different from the 3rd.

John Woodgate OOO-Own Opinions Only

J M Woodgate and Associates www.woodjohn.uk

Rayleigh, Essex UK
On 2017-12-06 00:40, Leo Eisner wrote:
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,

[photo]

Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: l...@eisnersafety.com
Website: www.EisnerSafety.com

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Re: [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

2017-12-06 Thread John Woodgate 
Re 'rationale', there is some information in Clause 0 of 62368-1 and in 
IEC 62368-2. But 60950-1 and 62368-1 are fundamentally different, 
because most of the provisions of 60950-1 were derived from experience 
and ad-hoc reasoning  but those of 62368-1 are derived from structured 
reasoning ('hazard-based standard').  Of course, experience and 
reasoning came to the same conclusion in some cases.


The 3rd edition of 62368-1 has most of the bugs removed. The 4th edition 
will, everyone hopes, not be very different from the 3rd.


John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK

On 2017-12-06 00:40, Leo Eisner wrote:
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,

photo   Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151 
Mobile: (503) 709-8328 
Email: l...@eisnersafety.com 
Website: www.EisnerSafety.com 
 
 
 
 
 



*** Internet E-mail Confidentiality Disclaimer ***
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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.


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Re: [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

2017-12-05 Thread IBM Ken 
Hi Leo!

ECMA released a Technical Report (TR-106) in February 2013, so be
forewarned that it only compares IEC60950-1, 2nd ed (2005) to the *1st*
(2010) edition of 62368-1.  A significant number of clauses were moved or
renumbered between 1st and 2nd edition (enough that it made it difficult to
use TR-106 to compare 60950-1 with 62368-1, 2nd edition).  I made some
cross-referencing notes for internal use, but even with that, it was fiddly
to use.   I don't know of anything that compares 60950-1 to the current
(2nd) edition or the upcoming 3rd edition.

Your favorite NRTL or test house might have something by way of training
material that could help.

-Ken

On Tue, Dec 5, 2017 at 7:40 PM, Leo Eisner  wrote:

> 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,
>
> [image: photo] Leonard (Leo) Eisner, P.E.
> Principal Consultant, Eisner Safety Consultants
> Phone: (503) 244-6151
> Mobile: (503) 709-8328
> Email: l...@eisnersafety.com
> Website: 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.
>
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> attachments that arise as a result of e-mail transmission.
> 
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>
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> 
>
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Re: [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

2017-12-05 Thread Brian O'Connell 
ECMA TR106, but was done for 1st ed only.

Brian


From: Leo Eisner [mailto:l...@eisnersafety.com] 
Sent: Tuesday, December 05, 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: (503) 244-6151
Mobile: (503) 709-8328
Email: l...@eisnersafety.com
Website: www.EisnerSafety.com
 

-

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[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

2017-12-05 Thread Leo Eisner 
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: (503) 244-6151 
Mobile: (503) 709-8328 
Email: l...@eisnersafety.com 
Website: www.EisnerSafety.com 
   
  
  
    

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