ISO/AWI 10993-3
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Reference number
ISO/AWI 10993-3
ISO/AWI 10993-3
Edición 4
© ISO 2024
Working draft
u
ISO/AWI 10993-3
88199
Resumen
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.
Informaciones generales
-
Estado: En desarrolloEtapa: Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
-
Edición: 4
-
Comité Técnico :ISO/TC 194
- RSS actualizaciones
Ciclo de vida
-
Anteriormente
PublicadoISO 10993-3:2014
-
Ahora
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)