ISO 18113-4:2009 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

标准编号：ISO 18113-4:2009

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：2009-12

标准范围

ISO 18113-4:2009规定了用于自检的体外诊断（IVD）试剂制造商提供的信息要求。ISO 18113-4:2009还适用于制造商提供的信息，以及用于IVD医疗设备自检的校准器和控制材料。ISO 18113-4:2009也适用于附件（如适用）。ISO 18113-4:2009适用于外部容器和直接容器的标签以及使用说明。

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.ISO 18113-4:2009 can also be applied to accessories, where appropriate.ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

标准预览图