ISO 10993-5:2009
ISO 10993-5:2009

ISO 10993-5:2009

May 2009
International standard Current

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

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.

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Main informations

Collections

International ISO standards

Publication date

May 2009

Number of pages

34 p.

Reference

ISO 10993-5:2009

ICS Codes

11.100.20   Biological evaluation of medical devices

Print number

3
Sumary
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

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.

Replaced standards (1)
ISO 10993-5:1999
ISO 10993-5:1999
May 1999
International standard Cancelled
Biological evaluation of medical devices. Part 5 : tests for in vitro cytotoxicity.

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