60.60 Standard published Mar 31, 2021
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
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 produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.
This document includes:
— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
— details of in vitro and in vivo irritation test procedures;
— key factors for the interpretation of the results.
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
Harmonized/Supporting
PUBLISHED
EN ISO 10993-23:2021
60.60
Standard published
Mar 31, 2021
IN_DEVELOPMENT
EN ISO 10993-23:2021/prA1