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NS-EN ISO 10993-10:2023

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

standard by Standards Norway NS-EN ISO , 02/14/2023

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Full Description

ADOPTED_FROM: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 Annex A.

 

Product Details

Published:
02/14/2023
Number of Pages:
64
File Size:
1 file , 1.6 MB
Product Code(s):
cc8e4dde-9aac-4e62-8170-cabdf7c39476, cc8e4dde-9aac-4e62-8170-cabdf7c39476, cc8e4dde-9aac-4e62-8170-cabdf7c39476
 

Document History

  1. NS-EN ISO 10993-10:2023

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

    • Most Recent

  2. NS-EN ISO 10993-10:2013


    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

    • Historical Version

  3. NS-EN ISO 10993-10:2010


    Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

    • Historical Version

  4. NS-EN ISO 10993-10:2009


    Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

    • Historical Version

  5. NS-EN ISO 10993-10:2002/A1:2006


    Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1 (ISO 10993-10:2002/Amd 1:2006)

    • Historical Version

  6. NS-EN ISO 10993-10:2002


    Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)

    • Historical Version

  7. NS-EN ISO 10993-10:1995


    Biological evaluation of medical devices — Part 10: Tests for irritation and sensitization (ISO 10993-10:1995)

    • Historical Version