EN
SR EN ISO 10993-3:2009
Evaluarea biologică a dispozitivelor medicale. Partea 3: Teste pentru genotoxicitate, carcinogenitate şi toxicitate asupra funcţiei de reproducere
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.
Status :
Anulat
Data aprobării : 30.10.2009
Data publicării : 01.11.2009
Data anulării : 31.03.2015
Număr de pagini : 28
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 10993-3:2004
- Inlocuit prin SR EN ISO 10993-3:2015