BSI BS EN ISO 10993-10:2023

Current Revision
Biological evaluation of medical devices -- Tests for irritation and skin sensitization

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BSI BS EN ISO 10993-10:2023

Biological evaluation of medical devices -- Tests for irritation and skin sensitization

PUBLISH DATE 2023
PAGES 64
BSI BS EN ISO 10993-10:2023

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.

This document includes:

  • details of in vivo skin sensitization test procedures;
  • key factors for the interpretation of the results.

NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in AnnexΒ A.

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