indieFeed
Organizers:
- Organized by
-
-
ISO 10993-1:2025
Disclaimer: Posts on IndieMedTech Forums are user-generated and do not reflect the views of IndieMedTech. Information shared here is for general discussion only and should not be considered professional or medical advice.
-
ISO 10993-1:2025
I see that ISO 10993-1: 2025 is under publication and will be releasing soon, and that the US voted “NO” for the changes. I can’t find any intel about what specific clauses the US objected to other than “cumulative use” (how repeated uses of a device add up in exposure) which will significantly revise (increase) the contact duration and therefore the categorization for many devices. Does anyone have any additional information as to how the US may diverge from the ROW on this standard?
-
1 Reply
-
I have also been hoping for some more information on this and guidance on how to raise this with clients so we can adequately anticipate any impact to testing strategies?
Log in to reply.