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AAMI ISO 10993-3:2014现行

Biological Evaluation Of Medical Devices - Part 3: Tests For Genotoxicity, Carcinogenicity, And Reproductive Toxicity

出版:Association for Advancement of Medical Instrumentation

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基本信息
标准编号: AAMI ISO 10993-3:2014
发布时间:2014/10/30 0:00:00
标准类别:Standard
出版单位:Association for Advancement of Medical Instrumentation
标准页数:50
标准简介

Defines 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.

本标准替代的旧标准

AAMI ISO 10993-3:2003 (R2013)

等同采用的国际标准

ISO 10993-3 : 2014 - Identical