nsBAS EN ISO 10993-10:2024
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
General information
Status:Project
Number of pages:58
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:28.03.2024
Forseen date for next stage code:27.05.2024
Technical committee:BAS/TC 25, Healthcare
Directives:
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
ICS:
11.100.20, Biological evaluation of medical devices
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
...
Original document and degree of correspondence
EN ISO 10993-10:2023, identical
ISO 10993-10:2021, identical
Relation to BAS standards
Work material
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