FDA and ISO stars aligning on ISO 10993 12 October 2018
Last month ISO published the long-awaited 5th Edition revision to ISO 10993-1. This update firmly brings biological evaluation into a well-developed risk management model, where the knowledge of device materials and chemistry becomes the central starting point and biological testing follows on only when it’s necessary to fill gaps in knowledge.
The famous Table A1 “checklist” has been updated and now is in close agreement with the FDA biocompatibility guidance.
This month join James Morrison for a deep dive into the new ISO 10993 part 1, and learn why biocompatibility must be based upon knowledge of materials, and how to minimise costly biological testing. James has been an active member of the ISO Technical Committee and been a key contributor to the development of the ISO 10993 standards. You won’t want to miss this one.