本文件规定了专业用途体外诊断（IVD）仪器制造商提供的信息要求。 本文件也适用于拟与IVD仪器一起使用以供专业使用的仪器和设备。 本文件也适用于附件。 本文件不适用于: a） 仪器维护或修理说明； b） IVD试剂，包括用于试剂控制的校准品和控制材料； c） 用于自检的IVD仪器。

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