ISO 10993-1:2009描述: 管理风险管​​理过程中医疗器械生物学评估的一般原则; 根据与身体接触的性质和持续时间对装置进行一般分类; 对所有来源的现有相关数据进行评估; 在风险分析的基础上确定现有数据集中的差距; 识别分析医疗器械生物安全性所需的附加数据集; 评估医疗器械的生物安全性

ISO 10993-1:2009 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.