标准编号：ISO 18113-4:2022
中文名称：体外诊断医疗器械 厂商提供的信息（标签） 第4部分：自测用体外诊断试剂
英文名称：In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
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) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.
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