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Norm

ÖNORM EN ISO 10993-5

Issue date: 2009 12 01

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

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact wi...
Valid
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 43 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
This part of ISO 10993 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.
ÖNORM EN ISO 10993-5
2009 12 01
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ÖNORM EN ISO 10993-5
1999 12 01
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ÖNORM EN 30993-5
1994 08 01
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ISO 10993-1:2009
Issue date : 2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
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ISO 10993-12:2007
Issue date : 2007 10 31
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2008-02)
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ISO 10993-1:2018
Issue date : 2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
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ISO 10993-5:2009
Issue date : 2009 05 20
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity