60.60 Standard published Sep 9, 2026
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100.20 Biological evaluation of medical devices
Draft
This document specifies strategies for risk estimation and evaluation of biological harms with respect to:
genotoxicity;
carcinogenicity;
reproductive toxicity; and
developmental toxicity.
This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.
This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.
NOTE Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.
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
WITHDRAWN
EN ISO 10993-3:2014
PUBLISHED
EN ISO 10993-3:2026
60.60
Standard published
Sep 9, 2026
