ISO/PWI 10993-5

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

General information

Current stage: 00.00 Effective date: Jun 16, 2022

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

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

PUBLISHED
ISO 10993-5:2009

NOW

IN_DEVELOPMENT
ISO/PWI 10993-5
00.00 Proposal for new project received
Jun 16, 2022