BAS EN ISO 10993-11:2010
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
General Information
Status: Withdrawn
No. of pages: 31
Language: English
Edition: 3.
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 10993-11:2006 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-11:2009, identical
- ISO 10993-11:2006, identical