ANSI/AAMI/ISO 10993-1-2009 医疗器械的生物学评价.第1部分:风险管理系统内的评价与测试

标准号：ANSI/AAMI/ISO 10993-1-2009
中文标准名称：医疗器械的生物学评价.第1部分:风险管理系统内的评价与测试
英文标准名称：Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
标准类型：C30
发布日期：2009/9/3 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
适用范围：Describes the general principles governing the biological evaluation of medical devices within a risk management framework; 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 analyze the biological safety of the medical device; and the assessment of the biological safety of the medical device.