Relationship of IEC 60601-1-6:2006 vs. IEC 60601-1 3rd Edition

[celia4237]

Before the implementation of the 3-rd edition of IEC 60601-1, Should we follow 60601-1-6:2006?

Since the publishment of 60601-1-6:2006 is 2006, which is after the publishment of the 3-rd edition of 60601-1, So Should we follow 60601-1-6:2006?

The other question, How to explain the complyment with IEC 60601-1-6? Usually, a test report from test house is needed or not?

[Marcelo Antunes]

IEC 60601-1-6 is a collateral standard (which is considered part of the general standard - see Harmonization date of IEC 60601-1 , 3rd Edition too) and, for the third edition, compliance to all collaterals standads applicable are required to claim compliance to the general standard (this requirement tries to fix the problem of having a general standard comprising different documents published in different times).

As the output of IEC 60601-1-6 is a usability engineering file (which is a risk mamanagement based file dealing with usability) usually then means to demonstrate compliance is a test report based on the review of this file (and the RMF, and the equipment, and other documents and processes which seems necessary to show compliance :-)) Anyway, remember that the implementation of IEC 60601-1-6 (differently from the compliance demonstration) can be a very demanding task, depending on your device and you company experience with usability and usability tests.

[celia4237]

It is very kind of you. I learn much knowledge from you. How lucky am i to meet a person like you in the start point of my journey on standards.

So, Now, since we are asked to offer a test report on IEC 60601-1-6:2006, Does it mean that, the collateral standard can be implemented even before the harmonization(in 2009) of the general standard, isn't it?

[Marcelo Antunes]

Yes. In fact, you "can" implement any standard you want anytime you want but you "must" implement the harmonized or recognized ones (or deal with the related risk in other ways) when they become recognized or harmonized.

In fact, usability is a requirement of both FDA and MDD, so you HAVE to deal with the risks related to usability. Complying with IEC 60601-1-6 is the easiest means to do that.