ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization

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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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Status: Active ChangeNumber: 4 InternationalClassificationCodeOfStandards: 11.100.20 TechnicalCommittee: ISO/TC 194 ActivatedDate: 16.11.2021 PagesCount: 48 Language: en

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