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SS-EN ISO 10993-1:2009現(xiàn)行

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

出版：Standardiserings-Kommissionen I Sverige

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基本信息
標(biāo)準(zhǔn)編號： SS-EN ISO 10993-1:2009
標(biāo)準(zhǔn)類別：Standard
出版單位：Standardiserings-Kommissionen I Sverige
標(biāo)準(zhǔn)頁數(shù)：0
標(biāo)準(zhǔn)簡介

This part of ISO 10993 describes:? - the general principles governing the biological evaluation of medical devices within a risk management process;? - the general categorization of devices based on the nature and duration of their contact with the body;? - the evaluation of existing relevant data from all sources;? - the identification of gaps in the available data set on the basis of a risk analysis;? - the identification of additional data sets necessary to analyse the biological safety of the medical device;? - the assessment of the biological safety of the medical device.

等同采用的國際標(biāo)準(zhǔn)

EN ISO 10993-1 : 2009 - Identical

ISO 10993-1 : 2009 - Identical

ISO 10993-1 : 2009 - Identical