BAS EN ISO 10993-3:2016
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
General Information
Status: Published
No. of pages: 40
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 18.05.2016
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
...
Abstract
ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:
genotoxicity;
carcinogenicity;
reproductive and developmental toxicity.
ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-3:2014, identical
- ISO 10993-3:2014, identical