BAS EN ISO 10993-5:2003
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
General Information
Status: Withdrawn
No. of pages: 17
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 18.11.2003
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices
93/42/EEC, Medical devices
...
Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-5:1999, identical
- ISO 10993-5:1999, identical