YY 0645-2008 (English Version) PDF

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.

YY 0645-2008 Referenced Document

GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB 9706.2-2003 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment
GB 9969.1 General principles for preparation of instructions for use of industrial products
GB/T 13074 Terms of blood purification*， 2009-05-06 Update
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 191 Packaging.Pictorial marking for handling of goods
YY 0466 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied