ANSI/AAMI/ISO 10993-5:2009/(R)2022
Active , Reaffirmed Standard
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ANSI/AAMI/ISO 10993-5:2009/(R)2022

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

Summary

This standard describes test methods to assess the in vitro cytotoxicity of devices. These methods specify the incubation of cultured cells either directly or through diffusion with extracts of the device, and/or in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2009
Confirmation Date 01/01/2022
Page Count 49
Themes Biological Evaluation
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