60.60 Standard published Feb 8, 2023
CEN/TC 206 Biological and clinical evaluation of medical devices
11.100.20 Biological evaluation of medical devices
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.
Legislation related to this standard
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
EN ISO 10993-10:2013
EN ISO 10993-10:2023
60.60 Standard published
Feb 8, 2023