标准摘要
[中文适用范围]： 本文件定义了概念，建立了一般原则，并规定了 IVD 医疗器械制造商提供的信息的基本要求。 本文件不涉及语言要求，因为这是国家法律法规的领域。 本文件不适用于： a) 用于性能评估的 IVD 医疗器械（例如仅用于研究用途）； b) 运输单据； c) 材料安全数据表/安全数据表； d) 营销信息（符合适用的法律要求）。 [外文原描述]： This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not address language requirements since that is the domain of national laws and regulations. This document does not apply to: a) IVD medical devices for performance evaluation (e.g. for investigational use only); b) shipping documents; c) material safety data sheets / Safety Data Sheets; d) marketing information (consistent with applicable legal requirements). .
英文名称In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements