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

ISO-10993-5 - 3RD EDITION - CURRENT
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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.

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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO 10993-5:2009

Revision Level

3RD EDITION

Status

Current

Publication Date

June 1, 2009

Committee Number

ISO/TC 194