ANSI/AAMI versions of 60601-1-2 and related testing requirements

[akp060]

I would like to know the differences in testing requirements or acceptance criteria for medical devices, between ANSI/AAMI and IEC versions of the standard 60601-1-2. The latter is partially recognized by the FDA and is there any significant test parameter or value related change in the ANSI version?

 

[jdoran]

I would like to know the differences in testing requirements or acceptance criteria for medical devices, between ANSI/AAMI and IEC versions of the standard 60601-1-2. The latter is partially recognized by the FDA and is there any significant test parameter or value related change in the ANSI version?

A quick bump, any update on this? @apk060, have you since determined any differences since posting this questions?

 

[Pads38]

As akp identified IEC 60601-1-2 is partially recognised by FDA. The one bit they do not recognise (IIRC) is the exemption of SIP/SOP cales less than 3m long from the conducted immunity tests. That is, all such cables, whatever length must be tested.

That particular test is (probably?) unlikely to be problematic. But I can well imagine a FDA reviewer homing in on that clause and checking to see whether that IEC exemption had been invoked. Recommendation - if you intend to 510(k) your device make sure ALL SIP/SOP cables get fully tested.

I do not know how this fits into ANSI standards; I can only surmise that this national deviation would be implemented.

 

[jdoran]

As akp identified IEC 60601-1-2 is partially recognised by FDA. The one bit they do not recognise (IIRC) is the exemption of SIP/SOP cales less than 3m long from the conducted immunity tests. That is, all such cables, whatever length must be tested.

That particular test is (probably?) unlikely to be problematic. But I can well imagine a FDA reviewer homing in on that clause and checking to see whether that IEC exemption had been invoked. Recommendation - if you intend to 510(k) your device make sure ALL SIP/SOP cables get fully tested.

I do not know how this fits into ANSI standards; I can only surmise that this national deviation would be implemented.

This is very informative, thanks! I notice the reason given by the FDA for SIP/SOP cables is "Excluding SIP/SOP cables less than 3 m in length from the IEC 61000-4-6 test is not recognized because of a technical error that was discovered after publication", do you know if that 'technical error' is in relation to IEC 61000-4-6 or IEC 60601-1-2?
I know from experience that conducted immunity testing on cables less than 1m is problematic because the couplers are typically of a similar length to 1 meter.