International Standard
ISO 10993-10:2021
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Reference number
ISO 10993-10:2021
Edition 4
2021-11
© ISO 2024
International Standard
Read sample
Published (Edition 4, 2021)

ISO 10993-10:2021

Format
Language
CHF 173
Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2021-11
    Stage
    : International Standard published [60.60]
  • Edition
     : 4
    Number of pages
     : 48
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
  • RSS updates

Life cycle

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.100
  7. 11.100.20
  8. ISO 10993-10:2021