ISO 17664-1:2021 医疗保健产品加工 医疗器械制造商为医疗器械加工提供的信息 第1部分：关键和半关键医疗器械
标准编号：ISO 17664-1:2021
中文名称：医疗保健产品加工 医疗器械制造商为医疗器械加工提供的信息 第1部分：关键和半关键医疗器械
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
发布日期：2021-07
标准范围
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。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说明。相反，本文件规定了帮助医疗器械制造商提供详细加工说明的要求，包括以下活动（如适用）:a） 使用时的初始治疗；b） 清洁前的准备工作；c） 清洁；d） 消毒；e） 干燥；f） 检查和维护；g） 包装；h） 消毒；i） 储存；j） 交通。本文件不包括以下内容的处理:-？非关键性医疗器械，除非其拟进行消毒；-？用于患者悬垂系统或手术服的纺织设备；-？制造商规定的一次性医疗器械，并随时提供。注？有关将ISO 17664系列应用于医疗器械的更多指南，请参见ISO 17664-2:2021附件E。
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.
标准预览图
