GB/T 29790-2013 in English

《GB/T 29790-2013即时检测 质量和能力的要求》由TC136（全国医用临床检验实验室和体外诊断系统标准化技术委员会）归口，主管部门为国家药品监督管理局。
本标准规定了适用于即时检测(POCT)的专用要求,并与GB/T22576―2008结合使用。本标准的要求适用于在医院、诊所或提供流动性医疗服务的医疗机构所进行的即时检测。本标准可适用于经皮测量、呼气分析及患者生理学参数的体内监测。
本标准不包括居家或在社区中的进行的患者自测,但本标准的要素可以适用。

Scope

This standard specifies the special requirements applicable to point-of-care testing (POCT), and is used in conjunction with GB/T 22576-2008. The requirements of this standard apply to the point-of-care tests performed in hospitals, clinics or medical institutions that provide ambulatory medical services. This standard can be applied to transcutaneous measurement, breath analysis and in vivo monitoring of physiological parameters of patients. This standard does not cover patient self-tests performed at home or in the community, but elements of this standard may apply.