BAS EN ISO 10993-11:2008
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
General Information
Status: Withdrawn
No. of pages: 31
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 21.07.2008
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices
93/42/EEC, Medical devices
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Abstract
This part of ISO 10993 specifies methodologies for the evaluation of the systematic toxicity potential of medical devices with release constituents into the body. In addition, it includes pyrogenicity testing. The test methods cited in this part of ISO 10993 are from International Standards, national standards, directives and regulations. This part of ISO 10993 is concerned with either the actual product or its leachables. It is intended that tests for extracts or leachables be conducted by choosing appropriate extraction vehicles to yield a maximum extraction of leachable materials, in order to conduct biological testing.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-11:2006, identical
- ISO 10993-11:2006, identical