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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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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WITHDRAWN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WITHDRAWN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