ISO 10993-1: NEW CORRECTED VERSION – Biological evaluation of medical devices

21 May 2022

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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