ISO 20417:2021 医疗器械 由制造商提供的信息

标准编号：ISO 20417:2021

中文名称：医疗器械 由制造商提供的信息

英文名称：Medical devices — Information to be supplied by the manufacturer

发布日期：2021-04

标准范围

笔记？1？条款A.2中包含了该条款的指导或理由。本文件规定了医疗器械制造商或附件制造商提供信息的要求，如3.1中所定义。本文件包括医疗器械或附件上的标识和标签、医疗器械或附件的包装、标记以及随附信息的一般适用要求。本文件没有规定提供信息的方式。笔记？2？一些有管辖权的机构对医疗器械或附件的识别、标记和文件有不同的要求。医疗器械产品标准或团体标准的具体要求优先于本文件的要求。

NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2.This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

标准预览图