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EN ISO 10993-5:2009 Standard

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  Keywords:

#methods #device #cells #biological #evaluation

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-5:1999"

Anyway is still possible use the "EN ISO 10993-5:1999" until December 31st, 2009

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