99.60 Withdrawal effective Oct 15, 2014
CEN/TC 206 Biological and clinical evaluation of medical devices
11.100.20 Biological evaluation of medical devices
ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.
ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
Guidance on selection of tests is provided in ISO 10993-1.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
EN ISO 10993-3:2003
EN ISO 10993-3:2009
99.60 Withdrawal effective
Oct 15, 2014
EN ISO 10993-3:2014