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Full Description

SAME AS ISO 10993-10

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 Annex A.

 

Document History

  1. DANSK DS/EN ISO 10993-10

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    Biological evaluation of medical devices – Part 10: Tests for skin sensitization (ISO 10993-10:2021)

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  2. DANSK DS/EN ISO 10993-10


    Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

    • Historical Version
  3. DANSK DS/EN ISO 10993-10


    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

    • Historical Version
  4. DANSK DS/EN ISO 10993-10


    Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

    • Historical Version