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DIN EN ISO 10993-5:2009-10

DIN EN ISO 10993-5:2009-10

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



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

Additional Info

Author DIN
Published by DIN
Document type Standard
Format File
ICS 11.100.20 : Biological evaluation of medical devices
Number of pages 46
Replace DIN EN ISO 10993-5 (1999-11)
Cross references EN ISO 10993-5 (2009-06), IDT
Year 2009
Document history DIN EN ISO 10993-5 (2009-10)
Country Germany
Keyword DIN EN ISO 10993;EN ISO 10993;EN ISO 10993-5;10993

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