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

Standard No.

BS EN ISO 10993-5:1999

Release Date

1999

Published By

British Standards Institution (BSI)

Status

Be replaced 2009-07

Replace By

BS EN ISO 10993-5:2009

Latest

BS EN 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.

BS EN ISO 10993-5:1999 history

• 2009 BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
• 1999 BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity