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

Standard No.

ANSI/AAMI/ISO 10993-5:2009

Release Date

2009

Published By

American National Standards Institute （ANSI)

Latest

ANSI/AAMI/ISO 10993-5:2009

Scope

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.

ANSI/AAMI/ISO 10993-5:2009 history

• 2009 ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity