EN ISO 10993-1 : 2009 COR 2010现行
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
出版：Comite Europeen de Normalisation
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基本信息
标准编号： EN ISO 10993-1 : 2009 COR 2010
标准类别：Standard
出版单位：Comite Europeen de Normalisation
标准页数：0
标准简介
Specifies: - 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.
