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

Standard No.

BS EN ISO 10993-5:2009

Release Date

2009

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 10993-5:2009

Replace

BS EN ISO 10993-5:1999 07/30160957 DC:2007

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 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.

BS EN ISO 10993-5:2009 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update

BS EN ISO 10993-5:2009 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