BS EN ISO 10993-5:2009

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Biological evaluation of medical devices Tests for in vitro cytotoxicity

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Language(s): English

Published date: 31-07-2009

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This part of ISO10993 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.

Committee	CH/194
Development Note	Supersedes BS EN 30993-5 & 97/563755 DC. (05/2005) Supersedes 07/30160957 DC. (07/2009)
Document Type	Standard
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Current
Supersedes	BS EN ISO 10993-5:1999 BS EN 30993-5:1994 97/563755 DC : OCT 97 07/30160957 DC : 0

BS 6155:1990	Specification for tracheal tubes for large animals in veterinary anaesthesia

ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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This part of ISO10993 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.

Committee	CH/194
Development Note	Supersedes BS EN 30993-5 & 97/563755 DC. (05/2005) Supersedes 07/30160957 DC. (07/2009)
Document Type	Standard
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Current
Supersedes	BS EN ISO 10993-5:1999 BS EN 30993-5:1994 97/563755 DC : OCT 97 07/30160957 DC : 0

BS 6155:1990	Specification for tracheal tubes for large animals in veterinary anaesthesia

ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process