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CAN/CSA-ISO 10993-5-01:2001 Edition

CAN/CSA-ISO 10993-5-01:2001 Edition

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Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity

Published By Publication Date Number of Pages
CSA 2001 18
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Scope

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 either directly or through 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.

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