UNE-EN ISO 17664-1:2022 介绍 本标准规定了医疗设备制造过程中所需的信息提供要求,特别针对关键性和次关键性医疗设备。它旨在确保制造商向加工方提供的资料详尽且准确,从而保障产品的安全与性能。该标准包括但不限于材料选择、工艺控制、质量保证和标签信息等方面的具体指导。 ***此介绍可能不准确,请注意参考原文...
BS EN ISO 17664-1:2021 保健品加工 医疗器械制造商为加工医疗器械而提供的信息 关键和半关键医疗设备 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices ...
标准号:ISO 17664-1:2021 EN 标准名称:保健产品的加工 医疗器械制造商应提供的医疗器械加工信息 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...
BS EN ISO 17664‑1:2021 — Tracked Changescompares BS EN ISO 17664‑121with BS EN ISO 17664:2017Processing 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 devicesI ...
BSI Standards PublicationProcessing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devicesPart 1: Critical and semi-critical medical devicesBS EN ISO 17664-1:2021
EN ISO 17664标准全称Processing of health care products - information to be provided by the medical device manufacturer for the processing of medical devices,意为“制造商需要提供的器械再处理说明”。也就是说,这是一个说明书要求。制造商需要在其说明书中详细列明该器械的再处理操作流程,才能使该器械实现...
ISO?17664:2004Sterilization of medical devices?–Information to be provided by the manufacturer for the processing of resterilizable medicaldevices (ISO?17664:2004);German version EN?ISO?17664:2004Stérilisation des dispositifs médicaux?–Informations devant être fournies par le fabricant pour le ...
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 17664December 2017ICS 11.080.01 Supersedes EN ISO 17664:2004EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels© 2017 CEN ...
Seite 11 prEN ISO 17664:2001 Anhang A (informativ) H?ufig angewendete Verfahren der Wiederaufbereitung A.1 Allgemeines Die folgende Matrix dient dem Hersteller von Medizinprodukten zur leichteren Bestimmung der Wiederaufbereitungsverfahren, die in die bereitgestellte Anleitung für die Wieder...
ISO17664:2017《Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices》标准已经被欧盟标准化机构采用为EN ISO 17664:2017标准,该标准规定了医疗器械制造商在使用说明书中提供处理医疗器械操作方法的要求。此处的“处理”意即清洗...