Standard Svensk standard · SS-EN ISO 10993-3:2014

Biologisk värdering av medicintekniska produkter - Del 3: Provning av genotoxicitet, carcinogenitet och toxisk inverkan på reproduktionen (ISO 10993-3:2014)

Status: Gällande

Omfattning
This part of ISO 10993 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.

This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

NOTE Guidance on selection of tests is provided in ISO 10993-1.

Ämnesområden

Biologisk värdering av medicintekniska produkter (11.100.20)


Produktinformation

Språk: Engelska

Framtagen av: Biologisk säkerhet, SIS/TK 340/AG 02

Internationell titel:

Artikelnummer: STD-103225

Utgåva: 3

Fastställd: 2014-10-19

Antal sidor: 52

Ersätter: SS-EN ISO 10993-3:2009