YY 0451-2010 in English

本标准规定了非电驱动一次性使用便携式输注泵(以下简称输注泵)基本要求和相应的试验方法。
适用于可持续给液(固定的或可调节)和(或)自控给液的输注泵。
本标准不适用于:
———IEC60601-2-24所包括的电驱动或电控制的输液泵;
———植入式装置;
———肠给养泵;
———经皮给液装置;
———输液动力不是装置自身提供动力,而是通过患者主动干预来获得动力(如:只靠重力作为动力的装置)

Scope

This standard specifies the basic requirements and corresponding test methods for non-electrically driven disposable portable infusion pumps (hereinafter referred to as infusion pumps). Infusion pumps suitable for continuous fluid delivery (fixed or adjustable) and/or self-controlled fluid delivery. This standard does not apply to:
　——Electrically driven or electrically controlled infusion pumps covered by IEC 60601-2-24;
　——Implantable devices;
　——Enteral feeding pumps;
　——Transcutaneous infusion devices;
　——Infusion power is not provided by the device itself Power is obtained through the patient's active intervention (for example: a device that relies solely on gravity as power).