Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All technical contents of this standard are mandatory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0645-2008 Continuous blood purification equipment, and the following main technical changes have been made with respect to YY 0645-2008:
——The application scope of the standard is further clarified;
——YY 0709 and YY 0054-2010 are added in the “Normative references”;
——The terms “fluid removal” and “equipment fluid balancing error” are redefined to make the definition more accurate;
——The description on classification and labeling is modified;
——The restriction on normal working conditions is appropriately adjusted.
——The accuracy of blood pump flow and the requirements for air entering the protective system as well as the test method are modified.
——The expressions of requirements for dialysate pump flow rate, substitution pump flow rate, equipment fluid removal error alarm, transmembrane pressure protective system, network power supply interruption and air entering protective system are modified.
——The requirements and test methods for heparin pump are modified;
——The requirements and test methods for blood leak protective system, weightometer, precaution or prevention of substitution fluid bag/dialysate bag being evacuated are added;
——The requirements of YY 0709 are added in the safety requirements;
——The requirements for marking, operating instructions, packaging, transport and storage are modified.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of SAC/TC 158 National Technical Committee on Extracorporeal Circuit Equipment of Standardization Administration of China.
The previous edition replaced by this standard is as follows:
——YY 0645-2008.
Continuous blood purification equipment
1 Scope
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
equipment fluid balancing error
difference between the actual total fluid output and the total fluid input within a specified time in case the fluid removal is zero
4 Classification and labeling
The main therapy modes of the equipment include:
a) continuous venovenous hemofiltration (CVVH);
b) continuous venovenous hemodialysis (CVVHD);
c) continuous venovenous hemodiafiltration (CVVHDF);
d) slow continuous ultrafiltration (SCUF);
e) high-volume hemofiltration (HVHF);
f) continuous plasmafiltration adsorption (CPFA).
5 Requirements
5.1 Normal working conditions
Unless otherwise specified by the manufacturer in the accompanying documents, the environmental conditions shall meet the following requirements:
a) ambient temperature: 10℃~30℃;
b) relative humidity: 30%~70%;
c) atmospheric pressure: 86 kPa~106 kPa;
d) AC power supply used: 220 V±22 V, and 50 Hz±1 Hz.
5.2 Flow monitoring
5.2.1 Blood pump flow rate
The error within the nominal range shall not exceed ±10% of the set value.
5.2.2 Dialysate pump flow rate
The error within the nominal range shall not exceed ±10% of the set value.
5.2.3 Substitution pump flow rate
The error within the nominal range shall not exceed ±10% of the set value.
5.2.4 Heparin pump flow rate
5.2.4.1 The error shall be ±0.2 mL/h or ±5% of the reading in the nominal range, whichever is greater in absolute value.
5.2.4.2 In case the heparin agent is injected, the equipment shall emit audible and visual alarm signals.
5.2.4.3 In case the heparin injection is blocked, the equipment shall emit audible and visual alarm signals.
5.3 Equipment fluid removal error
5.3.1 The equipment fluid removal error shall not exceed ±50 mL/h within the nominal range.
5.3.2 The accumulative error of the actual fluid removal of the equipment running for 8 h shall not exceed ±200 mL.
5.3.3 Alarm. The equipment shall have an independent protective system to prevent the actual fluid removal from deviating from the set value, and the maximum action value of the protective system shall be ±100 mL. The actions of the protective system shall realize the following safety conditions:
——activate audible and visual alarm signals;
——prevent the fluid removal from continuously deviating from the set value.
5.4 Equipment fluid balancing error
5.4.1 The equipment fluid balancing error shall not exceed ±50 mL/h.
5.4.2 The accumulative error of fluid balance of the equipment running for 8 h shall not exceed ±100 mL.
5.4.3 The measures to preclude or prevent the substitution fluid bag/dialysate bag from being evacuated shall be available for the equipment.
5.5 Temperature control
5.5.1 The setting range and accuracy of temperature control shall be specified in the operating instructions.
5.5.2 The temperature control accuracy shall comply with those specified in the operating instructions.
5.6 Pressure monitoring system
5.6.1 Venous pressure monitoring
5.6.1.1 The indication error within the nominal range shall not exceed the actual value±1.3 kPa (±10 mmHg).
5.6.1.2 It shall have high and low limit alarm function, and the error of alarm value shall not exceed the set value ±1.3 kPa(±10 mmHg).
5.6.1.3 In the therapy mode, the setting value of low limit alarm shall not be lower than 1.3 kPa (10 mmHg).
5.6.2 Arterial pressure monitoring
5.6.2.1 The indication error within the nominal range shall not exceed the actual value±1.3 kPa (±10 mmHg);
5.6.2.2 It shall have high and low limit alarm function, and the error of alarm value shall not exceed the set value ±1.3 kPa (±10 mmHg).
5.6.3 Transmembrane pressure monitoring
5.6.3.1 The indication error within the nominal range shall not exceed the actual value±2.7 kPa (±20 mmHg);
5.6.3.2 It shall have high limit alarm function, and the error of alarm value shall not exceed the set value ±2.7 kPa (±20 mmHg).
5.6.3.3 The actions of the protective system shall realize the following safety conditions:
——trigger audible and visual alarm signals;
——interrupt the flow of any dialysate and substitution fluid;
——interrupt the flow of any ultrafiltrate.
5.7 Network power supply interruption
The equipment shall be able to trigger audible and visual alarm signals in case of the network power supply interruption, and the blood in the extracorporeal tube may be completely transfused to the patient.
5.8 Air entering protective system
The equipment shall be provided with a protective system that prevents the air from entering.
The following two testing methods may be used as reference:
a) bubble detection method
For a protective system directly monitoring on the blood circuit, the alarm limit for continuous tiny bubbles or that for large bubble in the venous circuit shall be as specified by the manufacturer.
b) liquid level detection method
The equipment for which venous blood chamber liquid level detector is adopted shall be able to detect such a state that the blood height in the venous blood chamber is lower than the lower end of the detector.
5.9 Blood leak protective system
The equipment shall be provided with a blood leak protective system, and the maximum alarm limit shall be less than or equal to 0.35 mL/min (the HCT of the blood is 32%).
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and labeling
5 Requirements
6 Test methods
7 Marking, operating instructions, packaging, transport and storage
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All technical contents of this standard are mandatory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0645-2008 Continuous blood purification equipment, and the following main technical changes have been made with respect to YY 0645-2008:
——The application scope of the standard is further clarified;
——YY 0709 and YY 0054-2010 are added in the “Normative references”;
——The terms “fluid removal” and “equipment fluid balancing error” are redefined to make the definition more accurate;
——The description on classification and labeling is modified;
——The restriction on normal working conditions is appropriately adjusted.
——The accuracy of blood pump flow and the requirements for air entering the protective system as well as the test method are modified.
——The expressions of requirements for dialysate pump flow rate, substitution pump flow rate, equipment fluid removal error alarm, transmembrane pressure protective system, network power supply interruption and air entering protective system are modified.
——The requirements and test methods for heparin pump are modified;
——The requirements and test methods for blood leak protective system, weightometer, precaution or prevention of substitution fluid bag/dialysate bag being evacuated are added;
——The requirements of YY 0709 are added in the safety requirements;
——The requirements for marking, operating instructions, packaging, transport and storage are modified.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of SAC/TC 158 National Technical Committee on Extracorporeal Circuit Equipment of Standardization Administration of China.
The previous edition replaced by this standard is as follows:
——YY 0645-2008.
Continuous blood purification equipment
1 Scope
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
equipment fluid balancing error
difference between the actual total fluid output and the total fluid input within a specified time in case the fluid removal is zero
4 Classification and labeling
The main therapy modes of the equipment include:
a) continuous venovenous hemofiltration (CVVH);
b) continuous venovenous hemodialysis (CVVHD);
c) continuous venovenous hemodiafiltration (CVVHDF);
d) slow continuous ultrafiltration (SCUF);
e) high-volume hemofiltration (HVHF);
f) continuous plasmafiltration adsorption (CPFA).
5 Requirements
5.1 Normal working conditions
Unless otherwise specified by the manufacturer in the accompanying documents, the environmental conditions shall meet the following requirements:
a) ambient temperature: 10℃~30℃;
b) relative humidity: 30%~70%;
c) atmospheric pressure: 86 kPa~106 kPa;
d) AC power supply used: 220 V±22 V, and 50 Hz±1 Hz.
5.2 Flow monitoring
5.2.1 Blood pump flow rate
The error within the nominal range shall not exceed ±10% of the set value.
5.2.2 Dialysate pump flow rate
The error within the nominal range shall not exceed ±10% of the set value.
5.2.3 Substitution pump flow rate
The error within the nominal range shall not exceed ±10% of the set value.
5.2.4 Heparin pump flow rate
5.2.4.1 The error shall be ±0.2 mL/h or ±5% of the reading in the nominal range, whichever is greater in absolute value.
5.2.4.2 In case the heparin agent is injected, the equipment shall emit audible and visual alarm signals.
5.2.4.3 In case the heparin injection is blocked, the equipment shall emit audible and visual alarm signals.
5.3 Equipment fluid removal error
5.3.1 The equipment fluid removal error shall not exceed ±50 mL/h within the nominal range.
5.3.2 The accumulative error of the actual fluid removal of the equipment running for 8 h shall not exceed ±200 mL.
5.3.3 Alarm. The equipment shall have an independent protective system to prevent the actual fluid removal from deviating from the set value, and the maximum action value of the protective system shall be ±100 mL. The actions of the protective system shall realize the following safety conditions:
——activate audible and visual alarm signals;
——prevent the fluid removal from continuously deviating from the set value.
5.4 Equipment fluid balancing error
5.4.1 The equipment fluid balancing error shall not exceed ±50 mL/h.
5.4.2 The accumulative error of fluid balance of the equipment running for 8 h shall not exceed ±100 mL.
5.4.3 The measures to preclude or prevent the substitution fluid bag/dialysate bag from being evacuated shall be available for the equipment.
5.5 Temperature control
5.5.1 The setting range and accuracy of temperature control shall be specified in the operating instructions.
5.5.2 The temperature control accuracy shall comply with those specified in the operating instructions.
5.6 Pressure monitoring system
5.6.1 Venous pressure monitoring
5.6.1.1 The indication error within the nominal range shall not exceed the actual value±1.3 kPa (±10 mmHg).
5.6.1.2 It shall have high and low limit alarm function, and the error of alarm value shall not exceed the set value ±1.3 kPa(±10 mmHg).
5.6.1.3 In the therapy mode, the setting value of low limit alarm shall not be lower than 1.3 kPa (10 mmHg).
5.6.2 Arterial pressure monitoring
5.6.2.1 The indication error within the nominal range shall not exceed the actual value±1.3 kPa (±10 mmHg);
5.6.2.2 It shall have high and low limit alarm function, and the error of alarm value shall not exceed the set value ±1.3 kPa (±10 mmHg).
5.6.3 Transmembrane pressure monitoring
5.6.3.1 The indication error within the nominal range shall not exceed the actual value±2.7 kPa (±20 mmHg);
5.6.3.2 It shall have high limit alarm function, and the error of alarm value shall not exceed the set value ±2.7 kPa (±20 mmHg).
5.6.3.3 The actions of the protective system shall realize the following safety conditions:
——trigger audible and visual alarm signals;
——interrupt the flow of any dialysate and substitution fluid;
——interrupt the flow of any ultrafiltrate.
5.7 Network power supply interruption
The equipment shall be able to trigger audible and visual alarm signals in case of the network power supply interruption, and the blood in the extracorporeal tube may be completely transfused to the patient.
5.8 Air entering protective system
The equipment shall be provided with a protective system that prevents the air from entering.
The following two testing methods may be used as reference:
a) bubble detection method
For a protective system directly monitoring on the blood circuit, the alarm limit for continuous tiny bubbles or that for large bubble in the venous circuit shall be as specified by the manufacturer.
b) liquid level detection method
The equipment for which venous blood chamber liquid level detector is adopted shall be able to detect such a state that the blood height in the venous blood chamber is lower than the lower end of the detector.
5.9 Blood leak protective system
The equipment shall be provided with a blood leak protective system, and the maximum alarm limit shall be less than or equal to 0.35 mL/min (the HCT of the blood is 32%).
Contents of YY 0645-2018
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and labeling
5 Requirements
6 Test methods
7 Marking, operating instructions, packaging, transport and storage
