标准摘要
[中文适用范围]： 本文件规定了对用于自检的体外诊断 (IVD) 试剂、校准品和对照品制造商提供的信息的要求。 本文件也适用于配件。 本文件适用于外容器和直接容器的标签以及使用说明。 本文件不适用于： a) IVD 仪器或设备； b) 专业用IVD试剂。 [外文原描述]： 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.
英文名称In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing