YY/T 1469-2016 in English

本标准规定了便携式电动输液泵的定义、基本要求和相应的试验方法。
本标准适用于医疗监护环境下使用的便携式电动输液泵；该产品预期用途为静脉或硬膜外的镇痛给药。
本标准不适用于专门用于诊断或者类似用途的设备（例如高压注射器）、肠胃给养泵、用于血液体外循环的设备、胰岛素泵及相似临床应用的泵、对输液精度有特殊要求的便携式输液泵。

Scope

This standard specifies the definition, basic requirements and corresponding test methods of portable electric infusion pumps (hereinafter referred to as portable infusion pumps). This standard applies to portable electric infusion pumps used in medical monitoring environments; the intended use of this product is intravenous or epidural analgesic delivery. The portable infusion pump is mainly composed of a driving device, a liquid storage device and an infusion pipeline; the liquid storage device and the infusion pipeline are disposable parts. This standard does not apply to the following equipment:
　——Equipment specifically used for diagnosis or similar purposes (such as high-pressure syringes);
　——Gastrointestinal feeding pumps;
　——Equipment used for extracorporeal circulation of blood;
　——Insulin pumps and similar clinical applications Pump;
　——Portable infusion pump with special requirements for infusion accuracy.