标准编号：ISO 18113-1:2022
中文名称：体外诊断医疗器械 厂商提供的信息（标签） 第1部分：术语、定义和一般要求
英文名称：In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
发布日期：2022-10
标准范围
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).
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