This standard specifies the terms and definitions, classification and labeling, requirements, test methods as well as marking, operating instructions, packaging, transport and storage of the continuous blood purification equipment.
This standard is applicable to continuous blood purification equipment (hereinafter referred to as equipment). The equipment does not have the function of preparing substitution fluid or dialysate, and may be used for continuous blood purification therapy such as hemofiltration continuously performed for more than 24 hours.
This standard is not applicable to:
——water treatment unit;
——peritoneal dialysis equipment;
——equipment with hemoperfusion mode only;
——equipment with plasma therapy mode only;
——hemodialysis equipment;
——other equipment with a function of preparing substitution fluid or dialysate.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods (GB/T 191-2008; IS0 780:1997, MOD)
GB 9706.1 Medical electrical equipment - Part 1: General requirements for safety (GB 9706.1-2007; IEC 60601-1: 1988, IDT)
GB 9706.2 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (GB 9706.2-2003; IEC 60601-2-16: 1998, IDT)
GB/T 9969-2008 General principles for preparation of instructions for use of industrial products
GB/T 13074 Terms of blood purification
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY 0054-2010 Haemodialysis equipment
YY 0709 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.2, GB/T 13074 and the following apply.
3.1
fluid removal
difference between the total liquid output and the total liquid input of the equipment within a specified time
3.2
equipment fluid removal error
difference between the actual fluid removal of the equipment and the set value of the fluid removal within a specified time
3.3
