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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

Summary

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.

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 10/01/2009
Page Count 46
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