ISO 18113-5:2022 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 18113-5:2022

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：2022-10

标准范围

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. 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 professional use.

标准预览图