本文件规定了医疗器械制造商为处理非灭菌非关键医疗器械（即仅与完整皮肤接触的医疗器械或不与患者直接接触的医疗器械）提供的信息要求。 这包括在使用或重复使用医疗设备之前处理的信息。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 non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device.All current amendments available at time of purchase are included with the purchase of this document.