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
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.
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