Can anyone enlighten me on the use of AAMI HE-74?

[LiamD]

Can anyone enlighten me on the use of HE-74?

I see references to other standards related to Usability and Human factors - 60601-1-6, 62366-1, HE-75. But there is limited reference to HE-74.

How does HE-74 fit into Medical Development on both EU and US?

Thanks,
Liam

 

[Ronen E]

Re: HE-74

HE 74 is superseded.

 

[Marc]

Re: HE-74

What superseded AAMI HE-74?

 

[Ronen E]

Re: HE-74

Apparently HE 74 was incorporated into IEC 62366 as an Annex.

(broken link removed)

 

[LiamD]

Is there nothing more formal than a slide in a presentation from Abbott? Perhaps from the FDA or a test house?

 

[Jean_B]

The preview header for the AAMI edition of 62366:2013 states:

ANSI/AAMI/IEC 62366:2007(R)2013​

(Revision of ANSI/AAMI HE74:2001/(R)2009)
See: https://my.aami.org/aamiresources/previewfiles/62366_wA_1405_preview.pdf

Consensus standard notes on that revision of 62366:
https://www.accessdata.fda.gov/scri.../detail.cfm?standard__identification_no=34089

Thus going for the newest revision of 62366, including its corrigendum, is the way to go.

 

[LiamD]

- Perfect Jean_B just what I was looking for. Many thanks.