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ISO 10993:2021
ISO 10993:2021 Biological evaluation of medical devices – Part 10: Tests for skin sensitization
CDN $312.00
Description
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.
Edition
4
Published Date
2021-11-16
Status
PUBLISHED
Pages
48
Language
English
Format
Secure PDF
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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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