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) 仪器制造商提供的信息的要求。 本文件也适用于与 IVD 仪器一起使用进行自检的仪器和设备。 本文件也适用于配件。 本文件不适用于： a) 仪器保养或维修说明； b) IVD试剂，包括校准品和用于控制试剂的控制材料； c) 专业用途的 IVD 仪器。 [外文原描述]： 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.
英文名称In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing