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SRPS EN ISO 10993-5:2011

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

Aug 29, 2011

General information

60.60     Aug 29, 2011

ISS

Z076

European Norm

11.100.20  

English  

From plan 2011

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Scope

ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices.
These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.
These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Related directives

Directives related to this standard.

90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
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WITHDRAWN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 10993-5:2008

NOW

PUBLISHED
SRPS EN ISO 10993-5:2011
60.60 Standard published
Aug 29, 2011

Related project

Adopted from EN ISO 10993-5:2009

Adopted from ISO 10993-5:2009 IDENTICAL