I really hate to revive this old thread, but I want to answer
@TomQA's question.
Hello,
Could someone tell me what is ACTUALLY different between IEC 60601-1-6:2010/AMD2:2020 and IEC 62366-1:2015/AMD1:2020 ?
Thanks so much!
For all intents and purposes, since the 2020 amendments, nothing is different.
Technically, 60601-1-6 doesn't require maintenance of the Usability Engineering process, or the planning for and execution of production and post-production monitoring related to usability... but you're going to want to do those anyways. There are also some minor terminology differences, but these are not significant (amongst others, 60601-1-6 uses the terms "Operator" and "ME Equipment", whereas 62366-1 uses "User" and "Medical Device").
The situation is as follows:
60601-1 ("the general standard"), makes normative reference to 60601-1-6 ("the collateral standard" for usability) in Section 12.2.
12.2 USABILITY of ME EQUIPMENT
The MANUFACTURER shall address the RISK(S) of poor USABILITY, including those associated with
identification, marking and documents, through a USABILITY ENGINEERING PROCESS complying
with IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020.
The groups in charge of 60601-1-6 and 62366-1 recognized that there was significant overlap between the two standards. So, with the 2020 amendments, all of the important information in 60601-1-6 was moved to 62366-1.
Unfortunately, 60601-1-6 couldn't just be obsoleted, because of those references I just mentioned. And the references couldn't be changed to point to 62366-1 instead, because the general standard wasn't due for an update.
So for the moment, 60601-1-6 just serves as a fancy pointer to 62366-1. The general standard says to follow the collateral standard, and the collateral standard says to follow 62366-1.
Make sense?
All of these standards are available for super cheap through the Estonian National Standards Organization at evs.ee, if you would like to review them for yourself.
