Abstract

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

ISO 10993-10:2010 includes:

  • pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
  • details of in vivo (irritation and sensitization) test procedures;
  • key factors for the interpretation of the results.

Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.


General information 

  • Status
     :  Withdrawn
    Publication date
     : 2010-08
  • Edition
     : 3
    Number of pages
     : 67
  • Technical Committee
     : ISO/TC 194 Biological and clinical evaluation of medical devices
  • ICS
     :
    11.100.20 Biological evaluation of medical devices

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

3
Good Health and Well-being

Life cycle


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