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ISO 10993-5:2009

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

Publication date:   May 20, 2009

General information

90.93 Standard confirmed   Jun 16, 2022

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-5:1999

NOW

PUBLISHED
ISO 10993-5:2009
90.93 Standard confirmed
Jun 16, 2022

REVISED BY

ABANDON
ISO/CD 10993-5

IN_DEVELOPMENT
ISO/PWI 10993-5