Status : Published

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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.

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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 
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