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的要求。 ISO 18113-4:2009也适用于制造商提供的用于自检的IVD医疗设备的校准器和控制材料的信息。 ISO 18113-4:2009也适用于配件。 ISO 18113-4:2009适用于外部和立即集装箱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.