IEC 60601-1-6 2010 maps to IEC 62366:2007 - What about 62366-1:2015?

[clupin]

60601-1-6 2010 maps to 62366 2007. What about 62366-1 2015? Does this mean we can only use 62366 2007 to demonstrate conformance?

thanks!

 

[Marcelo]

There's an Amendment 2 for IEC 60601-1-6 in the works that will update the reference.

 

[clupin]

In the mean time do we follow 62366-1 and map it to 62366 in the UEF?

thanks

 

[yodon]

Looking at the differences, it would seem that the bulk of the changes are additions and clarifications. Very little was actually removed. So it would seem if you do follow -1 that you can make a pretty good case that you have sufficient detail to meet the intent (sufficiently controlled, risk-centric approach).

Wouldn't hurt to check with the test lab you're using (presuming you are) and get their inputs.

 

[Peter Selvey]

Need to check the context of the question.

62366 is an unusual standard because it applies anyway in isolation of IEC 60601-1-6.

So in the context of regulations you should be looking at how 62366 is listed in each regulation. In Europe they are still showing the older version. The FDA is showing the newer version without any transition (which is a bit odd, recently they started showing transitions periods).

For third party testing for IEC 60601-1, they should follow the IEC 60601-1-6 reference which currently to the older version. They need to at least wait for the amendment Marcelo mentioned to start using the newer version. Even then they should use the 3 year transition period as recommended by CENELEC. That gives time for everyone to get things in place (checklists, TRFs, accreditation etc).