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.