标准摘要
[中文适用范围]： 本文件规定了医疗器械制造商在处理关键或半关键医疗器械（即进入人体通常无菌部位的医疗器械或接触粘液的医疗器械）时提供的信息要求。 膜或不完整的皮肤）或需要消毒的医疗设备。 这包括在使用或重复使用医疗设备之前处理的信息。 本文档中未定义处理指令。 相反，本文件规定了协助医疗器械制造商提供详细处理说明的要求，其中包括以下活动（如果适用）： a）使用时的初步处理； b) 清洗前的准备工作； c) 清洁； d) 消毒； e) 干燥； f) 检查和维护； g) 包装； h) 灭菌； i) 储存； j) 运输。 本文件不包括对以下内容的处理： ——非关键医疗器械，除非打算对其进行灭菌； ——用于患者铺巾系统或手术服的纺织装置； ——制造商指定仅供一次性使用且可立即使用的医疗设备。 注：有关 ISO 17664 系列应用于医疗器械的进一步指导，请参阅 ISO 17664-2:2021，附录 E。 [外文原描述]： 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. This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: — non-critical medical devices unless they are intended to be sterilized; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.
英文名称Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices