ISO 10993-5:1999
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Standard No.

ISO 10993-5:1999

Release Date

1999

Published By

International Organization for Standardization (ISO)

Status

Withdraw 2009-06

Replace By

ISO 10993-5:2009

Latest

ISO 10993-5:2009

Scope

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion a) with extracts of a device, and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

ISO 10993-5:1999 history

• 2009 ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• 1999 ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
• 1992 ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods