Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good morning, 
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1. 
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.  

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

This message was posted by a user wishing to remain anonymous

See what Leo Eisner posted on his blog: https://eisnersafety.com/2020/12/22/fda-finally-adds-to-fall-2020-recognized-consensus-standards-db-for-cycle-update/


Update to post - 22 Dec 2020 - I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

Hi Anon

Your NRTL can recommend but cannot require use of the new version.  Also, folks, remember that while there is thankfully some harmonization, in the past certain countries (like China) did not accept test reports to versions they didn't recognize.  Also, make sure your NRTL is still accredited to the new version. Ask for their certification. 

Ask your NRTL if they will give you a free older version report based on test results to the new version, where tests and methods overlap.  I can tell you when v. 3.1 of IEC 60601-1 came out, I had CB reports for the same testing written against version 2.0, 3.0 and 3.1 of the Standard because the product was being globally registered. The NRTL repackaged/repurposed results in a lower version report template and charged for it.

Again, thankfully countries' regulatory agencies are catching up with new standard versions, but it is a work in progress.

I personally would not recommend abandoning a NRTL who can  issue a CB report (best for global submissions) just to use the fledgling ASCA program unless  you really think this will save you significant time and money at the lab, and during review. I think personally that ASCA could be another FDA overreach.  There are already agencies that certify labs....I am really not sure what data and resources FDA has that makes them think they should do this,  beyond their resources at OSEL.  I would prefer them to add and train reviewers on basic reviews.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 13-Apr-2021 13:38
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

See what Leo Eisner posted on his blog: https://eisnersafety.com/2020/12/22/fda-finally-adds-to-fall-2020-recognized-consensus-standards-db-for-cycle-update/


Update to post - 22 Dec 2020 - I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

Ginger,

Regarding ASCA - FDA is implementing this as it was an agreement with industry in the commitment letter to MDUFA IV (2017) - see Section IV.D (starting on p. 15 of the PDF) - in other words, industry (as represented by the applicable trade associations) asked for it.

(always enjoy your informative posts, by the way!)

------------------------------
Jonathan Amaya-Hodges
Associate Director, Regulatory Affairs CMC Combination Products and Medical Devices
Cambridge MA
United States
------------------------------

Original Message:
Sent: 14-Apr-2021 08:34
From: Ginger Cantor
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

Hi Anon

Your NRTL can recommend but cannot require use of the new version.  Also, folks, remember that while there is thankfully some harmonization, in the past certain countries (like China) did not accept test reports to versions they didn't recognize.  Also, make sure your NRTL is still accredited to the new version. Ask for their certification.

Ask your NRTL if they will give you a free older version report based on test results to the new version, where tests and methods overlap.  I can tell you when v. 3.1 of IEC 60601-1 came out, I had CB reports for the same testing written against version 2.0, 3.0 and 3.1 of the Standard because the product was being globally registered. The NRTL repackaged/repurposed results in a lower version report template and charged for it.

Again, thankfully countries' regulatory agencies are catching up with new standard versions, but it is a work in progress.

I personally would not recommend abandoning a NRTL who can  issue a CB report (best for global submissions) just to use the fledgling ASCA program unless  you really think this will save you significant time and money at the lab, and during review. I think personally that ASCA could be another FDA overreach.  There are already agencies that certify labs....I am really not sure what data and resources FDA has that makes them think they should do this,  beyond their resources at OSEL.  I would prefer them to add and train reviewers on basic reviews.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 13-Apr-2021 13:38
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

See what Leo Eisner posted on his blog: https://eisnersafety.com/2020/12/22/fda-finally-adds-to-fall-2020-recognized-consensus-standards-db-for-cycle-update/


Update to post - 22 Dec 2020 - I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

Hi Jonathan

Thanks for the note.  Yet, industry may often regret things they ask for. The Trade groups are often made of higher level company representatives or management who haven't created or handled a submission in years or decades. Something tells me the whole negotiation is like two marketing executives going to lunch and comparing regulatory strategies - "maybe if we use certified labs FDA likes, we will get a shorter review". Ha!

Like the 3654 and the new DoC in 510ks (similar but more onerous than 3654s), maybe this too shall pass into sunset, I hope.  CDRH  becomes more CDER like every single year.  The start of medical device lab inspections under BIMO type program, just as drug product test labs get inspected?

Have a good weekend everyone!










------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 15-Apr-2021 05:58
From: Jonathan Amaya-Hodges
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

Ginger,

Regarding ASCA - FDA is implementing this as it was an agreement with industry in the commitment letter to MDUFA IV (2017) - see Section IV.D (starting on p. 15 of the PDF) - in other words, industry (as represented by the applicable trade associations) asked for it.

(always enjoy your informative posts, by the way!)

------------------------------
Jonathan Amaya-Hodges
Associate Director, Regulatory Affairs CMC Combination Products and Medical Devices
Cambridge MA
United States

Original Message:
Sent: 14-Apr-2021 08:34
From: Ginger Cantor
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

Hi Anon

Your NRTL can recommend but cannot require use of the new version.  Also, folks, remember that while there is thankfully some harmonization, in the past certain countries (like China) did not accept test reports to versions they didn't recognize.  Also, make sure your NRTL is still accredited to the new version. Ask for their certification.

Ask your NRTL if they will give you a free older version report based on test results to the new version, where tests and methods overlap.  I can tell you when v. 3.1 of IEC 60601-1 came out, I had CB reports for the same testing written against version 2.0, 3.0 and 3.1 of the Standard because the product was being globally registered. The NRTL repackaged/repurposed results in a lower version report template and charged for it.

Again, thankfully countries' regulatory agencies are catching up with new standard versions, but it is a work in progress.

I personally would not recommend abandoning a NRTL who can  issue a CB report (best for global submissions) just to use the fledgling ASCA program unless  you really think this will save you significant time and money at the lab, and during review. I think personally that ASCA could be another FDA overreach.  There are already agencies that certify labs....I am really not sure what data and resources FDA has that makes them think they should do this,  beyond their resources at OSEL.  I would prefer them to add and train reviewers on basic reviews.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 13-Apr-2021 13:38
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

See what Leo Eisner posted on his blog: https://eisnersafety.com/2020/12/22/fda-finally-adds-to-fall-2020-recognized-consensus-standards-db-for-cycle-update/


Update to post - 22 Dec 2020 - I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

This message was posted by a user wishing to remain anonymous

Thanks Anon, 
Yes, I follow Leo's blog and I saw that post some months ago. Thanks for posting it again. 
I wonder if there are news on the ANSI/AAMI standard and what is the recommendation today: whether to use one version or the other. Also, how to deal with the inconsistencies on the normative standards.
Thanks!
Original Message:
Sent: 13-Apr-2021 13:38
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

See what Leo Eisner posted on his blog: https://eisnersafety.com/2020/12/22/fda-finally-adds-to-fall-2020-recognized-consensus-standards-db-for-cycle-update/


Update to post - 22 Dec 2020 - I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

You can use IEC 60601-1, 2020 (ed. 3.2) submission could be used.  Remember, the recognized list of standards are voluntary anyway and not mandatory.  

In regard to the ANSI ES 60601-1 I was just asking that question yesterday as I am on the US national committee for this standard.  I don't know the exact timing of when the standard will be issued. I'm hoping in the next couple of months but I don't know for sure.  The FDA is waiting for the standard AAMI ES 60601-1 version to be published before they will Recognize it. The AAMI ES 60601-1 version will be based on the updates on IEC 60601-1, ed. 3.2 that was published last summer 2020.  From what I can tell so far it doesn't seem like there will be any national deviations as the current draft voted on doesn't have any national deviations.  That could change but probably unlikely (can't guarantee).

I actually talk to the head of the SCAP (Standards & Conformity Assessment) program on a pretty regular basis about Standards Recognition, standards development, Essential Performance, nd many other topics.  I also communicate with others within that program and OSL as part of my standards development work and regular daily work to keep informed.  I was on the Expert Panel when the ASCA program rolled out initially and I discussed Essential Performance and worked with FDA helping them understand the concept of Essential Performance (did a little internal training). 

The ASCA program concept is that the test labs are to be supposed to be trained up and able to communicate now directly with the FDA (which was never the case previously).  Essential Performance has become a little bit contentious issue under the program from discussions with the labs.  It is the responsibility of the manufacturer to define Essential Performance by doing an analysis per clause 4.3 of 60601-1 but many manufacturer's don't understand clause 4.3 because it is written poorly in IEC 60601-1 (any of the versions as they haven't changed between the versions I don't believe).   There is a recently released Interpretation Sheet (ISH) on EP that you should read.  Please see my blog post on this as explains and points you to the ISH document.  Note, this is an issue that is also being discussed in the IEC SC 62A meetings I have been in this week (IEC General meetings - standards development meetings we do about every 18 months for the whole of the TEchnical Committee and the 4 sub-committees SC 62 A - D) so expect potentially more in the coming months or years ahead on EP.  I believe EP have been grossly misunderstood by test labs, manufacturers, standards developers and regulators alike and this has caused a lot of chaos.  



------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 14-Apr-2021 05:10
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Thanks Anon,
Yes, I follow Leo's blog and I saw that post some months ago. Thanks for posting it again.
I wonder if there are news on the ANSI/AAMI standard and what is the recommendation today: whether to use one version or the other. Also, how to deal with the inconsistencies on the normative standards.
Thanks!
Original Message:
Sent: 13-Apr-2021 13:38
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

See what Leo Eisner posted on his blog: https://eisnersafety.com/2020/12/22/fda-finally-adds-to-fall-2020-recognized-consensus-standards-db-for-cycle-update/


Update to post - 22 Dec 2020 - I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

This message was posted by a user wishing to remain anonymous

Hi Anon,
Would you mind sharing what lab you are using that wants to test to the 2020 amendment?
We have started considering re-testing current products and testing new products to the 2020 amendment for EU compliance with state of the art, but our test laboratory told us they are not yet ready to test to the latest amendment.

Thank you!
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

A NRTL lab or any Lab should not be insisting on anything as ISO 17025 say they should not be consulting and that sure sounds like consulting to me.  Or at least that sounds like up-selling.

Also, the update to the CB scheme Evaluation of Risk Management OD-2044 document is being updated currently.  The ETF-3 risk management group is meeting currently and hoping we will update that document for edition 3.2 of IEC 60601-1 which references ISO 14971:2019 vs ISO 14971:2007 so it needs to be updated which is a fairly big rewrite of the document.  It will take a couple of months to redo I suspect. The TRFs (Test report forms) for most of the IEC 60601-1 and collaterals exist other than IEC 60601-1-2 & 60601-1-9 for the CB scheme that align with the Amendments. I am on the CB Scheme ETF-3 Risk Management Group team as well.  I try hard to keep up on these moving parts.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 15-Apr-2021 14:16
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Hi Anon,
Would you mind sharing what lab you are using that wants to test to the 2020 amendment?
We have started considering re-testing current products and testing new products to the 2020 amendment for EU compliance with state of the art, but our test laboratory told us they are not yet ready to test to the latest amendment.

Thank you!
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)

This message was posted by a user wishing to remain anonymous

Thanks everybody for the helpful answers.

Anon, we are using TUV Munich. They recommended us the new version of the standard.
Hope it helps.
Original Message:
Sent: 15-Apr-2021 14:16
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Hi Anon,
Would you mind sharing what lab you are using that wants to test to the 2020 amendment?
We have started considering re-testing current products and testing new products to the 2020 amendment for EU compliance with state of the art, but our test laboratory told us they are not yet ready to test to the latest amendment.

Thank you!
Original Message:
Sent: 13-Apr-2021 08:57
From: Anonymous Member
Subject: 60601-1 2020 amendment - inconsistencies FDA recognition vs. normative standards

This message was posted by a user wishing to remain anonymous

Good morning,
I don't have completely clear which version of the 60601-1 standard we should use for an FDA submission. The standard database is still recommending the old version of the standard (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,), however our NRTL lab insists on using the new one (2020 IEC amendment).

Also, it seems inconsistent to me if we use the 2012 version of 60601-1 recognized by FDA ,and we simultaneously use the latest versions of standards (also recognized by FDA) like 14971, 62133-2 (lithium batteries), 62366-1, etc., considering that these latter are not recognized by the old 60601-1.
What do you suggest to solve this puzzle?

A separate question is whether you recommend to use one of the ASCA labs (new program in CDRH) for testing. I wonder if the new program is mature enough and if it makes sense to abandon our current NRTL lab to try this new strategy.

Thanks for any help you can provide, I hope Leonard Eisner jumps in in the discussion too, as I know he is very knowledgeable on this topic :)