标准编号：ISO 18113-3:2022
中文名称：体外诊断医疗器械 厂商提供的信息（标签） 第3部分：专业用体外诊断仪器
英文名称：In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
发布日期：2022-10
标准范围
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for self-testing.
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