ISO 10993-3:2014

Biological evaluation of medical devices-- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Autor: ISO
Código ICS: 11.100.20
Vigente
$226.100

Alcance

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.

Especificaciones de la Norma
Fecha de Publicación 24/09/2014
Título Secundario Évaluation biologique des dispositifs médicaux-- Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction
Páginas Técnicas 34
Idioma Inglés