ISO 10993-10:2021
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ISO 10993-10:2021
75279

Abstract  Preview

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 

  •  :  Published
     : 2021-11
  •  : 4
     : 48
  •  : ISO/TC 194 Biological and clinical evaluation of medical devices
  •  :
    11.100.20 Biological evaluation of medical devices

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