Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

20-05-2009

Publisher

International Organization for Standardization

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.

DevelopmentNote	Supersedes ISO/DIS 10993-5. (05/2009)
DocumentType	Standard
Pages	34
ProductNote	Supersedes ISO/DIS 10993-5. (Seema 05/2009)
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 10993-5:1999

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