BAS EN ISO 10993-3:2010
Biološko ocjenjivanje medicinskih sredstava - dio 3: ispitivanja genotoksičnosti, kancerogenosti i reproduktivne toksičnosti
Opšte informacije
Status: Povučen
Broj strana: 20
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Datum objave: 25.06.2010
Tehnički komitet:
Direktiva:
93/42/EEC, Medicinska sredstva
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Apstrakt
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.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 10993-3:2009, identičan
- ISO 10993-3:2003, identičan