SR EN ISO 10993-5:2009

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

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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General information

Status : Valid
Approval date : 11/30/2009
Publish date : 12/2/2009
Number of pages : 46
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 10993-5:2003
Amended by SR EN ISO 10993-5:2009/A11:2025