The answer as in many cases is it depends. Based on where is it located on impacts the standards that apply. IEC 60601-1, IEC 61010-1, IEC 60950-1, IEC 62368-1, etc. are possible options depending on location used and also depending country marketed in and regulatory approval process, etc. Is it located in the OR, it is in the Patient environment based on the IEC 60601-1 requirement of the patient environment. Is it an accessory to a medical device or is it an accessory to a laboratory device? Is it used in the home environment or is it located in a professional environment (hospital, clinic, dr.'s office, etc.)? Is it accessible to a child, operators, patients, or which combination? These all have impacts on which standard applies to the charger and also the location of the charger in the overall system as well. So, not a straight forward answer. Please contact me directly for further guidance.
------------------------------
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.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 01-May-2020 14:05
From: Anonymous Member
Subject: lithium batteries IEC vs. UL
This message was posted by a user wishing to remain anonymous
Hi all,
I would like to follow-up on this old post.
Do you have recommendations for which standards to use for the battery charger (of a lithium battery) in USA (FDA & OSHA)?
Thanks
Original Message:
Sent: 27-Mar-2020 12:10
From: Leonard Eisner
Subject: lithium batteries IEC vs. UL
ANSI/AAMI of IEC 60601-1:2005 +A1:2012 is the same standard unless you run into the US national deviations which is about 1 page of items which are mainly dealing with mains power issues focused around x-ray & NFPA 99 issues. You should look at them just in case but probably won't impact your device unless x-ray device or heavy on the mains power side of things.
------------------------------
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: 26-Mar-2020 13:26
From: Anonymous Member
Subject: lithium batteries IEC vs. UL
This message was posted by a user wishing to remain anonymous
Thank you all.
Leonard, yes that's exactly our scenario, except that we want to test to the ANSI/AAMI version of the standard (not the IEC), accepted by the FDA.
Original Message:
Sent: 25-Mar-2020 09:23
From: Anonymous Member
Subject: lithium batteries IEC vs. UL
This message was posted by a user wishing to remain anonymous
This thread a few months ago had some input on this topic of batteries and standards:
https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=7421f9af-61d7-4ae3-b230-c8f69d284a79&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bm7421f9af-61d7-4ae3-b230-c8f69d284a79
Original Message:
Sent: 24-Mar-2020 14:05
From: Anonymous Member
Subject: lithium batteries IEC vs. UL
This message was posted by a user wishing to remain anonymous
Hi all,
I haven't managed to get a clear picture on the standards we need to use for our device which is powered by a rechargeable lithium battery.
I initially thought that having a IEC 62133-2 (2017) certificate + UN 38.3 certificate from the supplier would have done the job both for CE mark and the FDA (+ NRTL).
However, I found websites where it is recommended to use UL 1642 and UL 2054 (instead of IEC) for NRTL certification.
What are your thoughts on the need of UL 1642 and UL 2054 standards for US market? Also, can you comment on IEC 62281 vs. UN 38.3?
Ideally I would like to limit the burden and have something that works for both European and US market at the same time (I hope it is not a dream).
Please advice. Thanks!