EN
SR EN ISO 10993-3:2015
Evaluarea biologică a dispozitivelor medicale. Partea 3: Teste pentru genotoxicitate, carcinogenitate şi toxicitate asupra funcţiei de reproducere
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.
Status :
In vigoare
Data aprobării : 31.03.2015
Număr de pagini : 49
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN ISO 10993-3:2009