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

Standard No.

EN ISO 10993-5:2009

Release Date

2009

Published By

European Committee for Standardization (CEN)

Status

Withdraw 2009-12

Latest

EN ISO 10993-5:2009

Replace By

prEN ISO 10993-5 rev

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.

EN ISO 10993-5:2009 history

• 2009 EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
• 1999 EN ISO 10993-5:1999 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity ISO 10993-5:1999; Supersedes EN 30993-5:1994