ISO 10993-1: NEW CORRECTED VERSION – Biological evaluation of medical devices
4 December 2021
The new 5th edition of the biocompatibility standard, ISO 10993-1-2018, was released in August and corrected version in October 2018.
The new version, released in August, replaces the 2009 version of the standard. We would like highlight some issues:
- Evaluation Tests for Consideration, was expanded (including eg. carsinogenicity and chronic toxicity, reproductive/developmental toxicity)
- Expansion of the standard to include evaluation of nanomaterials and absorbable materials.
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