SR EN ISO 10993-10:2023

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

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 : Valid
Approval date : 3/31/2023
Number of pages : 63
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 10993-10:2014