本文件规定了医疗器械制造商为处理关键或半关键医疗器械（即进入人体正常无菌部位的医疗器械或接触粘膜或非完整皮肤的医疗器械）或拟灭菌医疗器械而提供的信息要求。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 requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.All current amendments available at time of purchase are included with the purchase of this document.