SR EN 30993-5:1996

Biological evaluation of medical devices. Part 5: Tests for cytotoxicity: in vitro methods

This part of ISO 10993 describes test methods to assess the in-vitro cytotoxicity of medical and dental materials and devices. These methods specify the incubation of cultured cells either directly or through diffusion: a) with extracts of the material or of the device and/or b) in contact with a material or device. These methods are designed to determine the biological response of mammalian cells in-vitro using appropriate biological parameters.

Status : Withdrawn
Approval date : 7/11/1995
Publish date : 7/12/1995
Withdrawal date : 9/17/2003
Number of pages : 16
ICS : 11.020 Medical sciences and health care facilities in general
Technical Committee : 377 - Medical devices

Relations with other standards: