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
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
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Estado: En desarrolloEtapa: Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
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Edición: 4
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Comité Técnico :ISO/TC 194
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Ciclo de vida
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Anteriormente
PublicadoISO 10993-3:2014
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Ahora
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