SSH EN ISO 10993-3:2009

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 3: Provat për genotoksicitetin, karcinogenicitetin dhe toksicitetin riprodhues

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

Scope

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.
ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
Guidance on selection of tests is provided in ISO 10993-1.

Related directives

Directives related to this standards.