BAS EN ISO 10993-5:2010
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
General Information
Status: Published
No. of pages: 39
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
...
Abstract
ISO 10993-5:2009 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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-5:2009, identical
- ISO 10993-5:2009, identical