Hello Anon,
You can go with either, though there are some standards which when released as ANSI/AAMI (and other bodies) make some deviations which are specific to the United States. The two you gave are good examples, ISO 10993-1 and ANSI/AAMI version are the same in content - some of the preluding information explains U.S. "understandings" whereas IEC 60601-1 and ANSI/AAMI ES 60601-1 do contain country deviations for the content. While the FDA lists both on the recognised standard list, and either could be listed in a 510(k)/De Novo/PMA, you should be clear when it comes down to the testing whether there are deviations which are specific to the U.S. As example, I have seen 510(k) submission only list IEC 60601-1 as the recognized standard (number 19-49) however when reviewing the testing report in the Electrical Safety section, needs to include the testing for ANSI/AAMU ES 60601-1.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Aug-2023 12:08
From: Anonymous Member
Subject: FDA Recognized Consensus Standards: Medical Devices, which one???
This message was posted by a user wishing to remain anonymous
I need some clarification about the FDA Recognized Consensus Standards, specifically about FDA listing the international and the U.S. Identical Adoption of the same standard as recognized.
It makes sense that for the US we should go with the U.S. Identical Adoption. However, the international standard is listed as well, so both should be accepted. Is that correct?
One example is biocomp.
There is the ANSI AAMI 10993-1 and the ISO 10993-1. They are listed under the same Recognition number, so we can go with either ISO or ANSI ?
What about the 60601-1? there are the IEC and the ANSI listed under two separate recognition numbers. So do you go with the IEC or ANSI ?
Many thanks,