本文件规定: -风险范围内医疗器械生物学评价的一般原则 管理流程；-根据接触的性质和持续时间对医疗器械进行一般分类 身体；-评估所有来源的现有相关数据；-在风险分析的基础上确定可用数据集的差距确定分析医疗设备生物安全性所需的其他数据集 设备；-医疗器械的生物安全性评估。购买本文件时可获得的所有当前修订均包含在购买本文件中。

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.All current amendments available at time of purchase are included with the purchase of this document.