Borrador del Comité
ISO/CD 10993-3
Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity
Reference number
ISO/CD 10993-3
ISO/CD 10993-3
Edition 4
© ISO 2024
Borrador del Comité
ISO/CD 10993-3
88199
Resumen
ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, 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: Cierre del periodo de observaciones [30.60]
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Edición: 4
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Comité Técnico :ISO/TC 194
- RSS actualizaciones
Ciclo de vida
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Anteriormente
PublicadoISO 10993-3:2014
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Ahora
