本文件规定:在风险管理过程中管理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医疗器械进行一般分类；评估所有来源的现有相关数据；根据风险分析确定可用数据集中的差距；确定分析医疗器械生物安全性所需的其他数据集；医疗器械的生物安全性评估。

This document specifies:the general principles governing the biological evaluation of medical devices within a risk management process;the general categorization of medical 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.