标准摘要
[中文适用范围]： 注1：本条款在A.2.1节中提供了指导或依据。本文件规定了制造商针对医疗器械或附件（定义见3.1）所提供的信息所应满足的要求。文件涵盖医疗器械或附件的标识与标签、包装、标记以及随附信息的通用要求。本文件未规定信息提供的方式。注2：部分主管当局对医疗器械或附件的标识、标记及文档可能有不同要求。医疗器械产品标准或系列标准中的具体要求优先于本文件的规定。 [外文原描述]： ISO 20417 specifies the general requirements for information supplied by the manufacturer for medical devices and accessories, including i dentification, labelling, packaging information, marking and accompanying documentation such as instructions for use . The standard provides a central framework of common requirements that can be used by specific product or group standards for medical devices. This allows those standards to focus on device-specific needs while ensuring consistent baseline expectations for information and labelling. This second edition replaces ISO 20417:2021 and has been technically revised. Updates include revised normative references, removal of several informative annexes and the introduction of the concept of an “applicable policy”.
英文名称Medical devices — Information to be supplied by the manufacturer