ISO 10993-5:2009

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

Publication date: May 20, 2009

General information

Current stage: 90.93 Effective date: Jun 16, 2022

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Languages: English French

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Status: 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

Revises
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

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