BAS EN ISO 10993-10:2024
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
General Information
Status: Published
No. of pages: 58
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 10.06.2024
Technical committee:
Directive:
2017/745, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-10:2023, identical
- ISO 10993-10:2021, identical