ISO 18113-5:2009 体外诊断医疗器械 厂商提供的信息（标签） 第5部分：自测用体外诊断仪器

标准编号：ISO 18113-5:2009

中文名称：体外诊断医疗器械 厂商提供的信息（标签） 第5部分：自测用体外诊断仪器

英文名称：In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

发布日期：2009-12

标准范围

ISO 18113-5:2009规定了对用于自检的体外诊断（IVD）仪器制造商提供的信息的要求。ISO 18113-5:2009也适用于拟与IVD仪器一起用于自检的仪器和设备。ISO 18113-5:2009也适用于附件。

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.ISO 18113-5:2009 can also be applied to accessories.

标准预览图