Biological evaluation of medical devices Tests for in vitro cytotoxicity

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-07-2009

Publisher

British Standards Institution

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
DevelopmentNote	Supersedes BS EN 30993-5 & 97/563755 DC. (05/2005) Supersedes 07/30160957 DC. (07/2009)
DocumentType	Standard
Pages	46
PublisherName	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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BS EN ISO 10993-5:2009