Standard Swedish standard · SS-EN ISO 10993-5:2009

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

Status: Valid

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 in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Subjects

Biological evaluation of medical devices (11.100.20)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-70026

Edition: 2

Approved: 6/15/2009

No of pages: 52

Replaces: SS-EN ISO 10993-5