SR EN ISO 10993-5:2003

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

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 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.

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General information

Status : Withdrawn
Approval date : 9/17/2003
Publish date : 9/18/2003
Withdrawal date : 11/30/2009
Number of pages : 22
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 30993-5:1996
Replaced by SR EN ISO 10993-5:2009