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

Standard No.

ISO 10993-5:2009

Release Date

2009

Published By

International Organization for Standardization (ISO)

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 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.

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

ISO 10993-5:2009 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