YY 0645-2008 in English

本标准规定了连续性血液净化设备的术语和定义、分类与标记、要求、试验方法、标志、使用说明书书和包装、运输和贮存。
本标准适用于连续性血液净化设备。该设备不包括置换液或透析液配制系统，可用于连续进行24h以上的血液滤过等血液净化治疗。
本标准不适用于：
——血液透析制水设备；
——腹膜透析设备；
——血液灌流、血浆治疗的设备；
——血液透析设备。

Scope

This standard specifies the terms and definitions, classification and labeling, requirements, test methods, signs, instructions for use and packaging, transportation and storage of continuous blood purification equipment. This standard applies to continuous blood purification equipment (hereinafter referred to as equipment). This device does not include a replacement fluid or dialysate preparation system and can be used to continuously perform blood purification treatments such as hemofiltration for more than 24 hours. This standard does not apply to:
　——Hemodialysis water production equipment;
　——Peritoneal dialysis equipment;
　——Hemoperfusion and plasma treatment equipment;
　——Hemodialysis equipment.