ISO 15198:2004描述了体外诊断医疗设备制造商验证其向用户推荐的质量控制程序的过程。这些质量控制程序旨在为用户提供设备性能与其预期用途和制造商声明一致的保证。ISO 15198:2004适用于所有体外诊断医疗设备。

ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.