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SRPS EN ISO 10993-3:2011

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

Sep 30, 2011
95.99 Withdrawal of Standard   Jan 31, 2017

General information

95.99     Jan 31, 2017

ISS

Z076

European Norm

11.100.20  

English  

From plan 2011

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Scope

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.

Related directives

Directives related to this standard.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
2007/47/EC

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

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 10993-3:2008

NOW

WITHDRAWN
SRPS EN ISO 10993-3:2011
95.99 Withdrawal of Standard
Jan 31, 2017

REVISED BY

PUBLISHED
SRPS EN ISO 10993-3:2017

Related project

Adopted from EN ISO 10993-3:2009

Adopted from ISO 10993-3:2003 IDENTICAL