YY 0054-2023 English PDF (YY0054-2023)

This Document specifies the classification and requirements of hemodialysis equipment and describes its test methods. This Document applies to hemodialysis equipment with automatic preparation of dialysis fluid.

YY/T 0054-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
CCS C 45
Replacing YY/T 0054-2010
Hemodialysis Equipment
血液透析设备
ISSUED ON: JANUARY 13, 2023
IMPLEMENTED ON: JANUARY 15, 2026
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4
1 Scope ... 7
2 Normative References ... 7
3 Terms and Definitions ... 8
4 Classification ... 8
5 Requirements ... 8
5.1 Normal working conditions of the equipment ... 8
5.2 Flow control ... 9
5.3 Dialysate composition ... 11
5.4 Filtration-sterilization system ... 11
5.5 Control and protection of dialysate conductivity ... 12
5.6 Temperature control ... 13
5.7 Pressure monitoring ... 14
5.8 Dialysate flow, temperature and conductivity stability ... 15
5.9 Blood leakage protection system ... 15
5.10 Prevent air from entering ... 15
5.11 pH measuring device ... 16
5.12 Network power supply interruption ... 16
5.13 Degassing function ... 16
5.14 Waste liquid protection ... 16
5.15 Disinfection ... 16
5.16 Operating noise ... 18
5.17 Appearance and structure ... 18
5.18 Safety requirements ... 19
5.19 Environmental test ... 19
6 Test Methods ... 19
6.1 Test working conditions ... 19
6.2 Flow control test ... 20
6.3 Dialysate composition test ... 25
6.4 Filtration-sterilization system test ... 25
6.5 Dialysate conductivity control and protection test ... 26
6.6 Temperature control system test ... 28
6.7 Pressure monitoring test ... 29
6.8 Dialysate flow, temperature, conductivity stability test ... 30
6.9 Blood leakage protection system test ... 31
6.10 Test to prevent air from entering ... 32
6.11 pH measuring device test ... 33
6.12 Network power supply interruption test ... 33
6.13 Degassing function test ... 33
6.14 Waste liquid protection test ... 33
6.15 Disinfection test ... 34
6.16 Working noise test ... 37
6.17 Appearance and structural testing ... 37
6.18 Safety requirements test ... 37
6.19 Environmental test ... 37
Hemodialysis Equipment
1 Scope
This Document specifies the classification and requirements of hemodialysis equipment and describes its test methods.
This Document applies to hemodialysis equipment with automatic preparation of dialysis fluid (hereinafter referred to as equipment).
This Document does not apply to:
--- Hemodialysis water treatment equipment;
--- Peritoneal dialysis equipment;
--- Hemoperfusion, plasma exchange, and plasma adsorption equipment;
--- Continuous blood purification equipment;
--- Central liquid supply system;
--- Hemodialysis equipment with regenerable dialysate.
2 Normative References
The provisions in following documents become the essential provisions of this Document through reference in this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable to this Document.
GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.216 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
YY 0598 Concentrates for hemodialysis and related therapies
YY 1272-2016 Dialysis fluid filter
a) Ambient temperature: 10℃~30℃ or as specified by the manufacturer;
b) Relative humidity: ≤70% or as specified by the manufacturer;
c) Atmospheric pressure: 86kPa~106kPa or as specified by the manufacturer; d) Power supply: a.c. 220 × (1±10%) V, 50 × (1±2%) Hz or as specified by the manufacturer; e) Inlet water temperature: as specified by the manufacturer;
f) Inlet water pressure: as specified by the manufacturer.
5.2 Flow control
5.2.1 Blood flow error
The blood flow of the device shall comply with the following provisions: a) The blood flow control range of the device shall comply with the manufacturer's specifications;
b) The blood flow control error of the device shall comply with the manufacturer's specifications;
c) If applicable, the display error of blood flow shall comply with the manufacturer's specifications.
NOTE 1: Blood flow lower than the set value is considered unfavorable for typical treatment. Therefore, the goal of this experiment is to find the maximum negative blood flow error; and it is generally considered that the negative error of the control error is no less than -10%. NOTE 2: Fatigue of pump tubing segments may reduce blood flow.
NOTE 3: Blood flow in a peristaltic pump may be affected by input negative pressure. 5.2.2 Dialysate flow error
The dialysate flow of the equipment shall comply with the following provisions: a) The dialysate flow control range of the equipment shall comply with the manufacturer’s specifications;
b) The dialysate flow control error of the equipment shall comply with the manufacturer's specifications.
NOTE: When the dialysate flow rate is lower than the set value, it is considered unfavorable for typical treatment; and the negative error is generally considered to be no less than -10%. 5.2.3 Net dehydration control
5.2.3.1 Net dehydration error
The net dehydration of the equipment shall comply with the following provisions: a) Net dehydration of the equipment shall be achieved in accordance with the manufacturer's specifications;
b) Within the nominal net dehydration rate range of the equipment, the allowable error of the net dehydration rate shall be ±5% or ±100mL/h, whichever is the larger absolute value;
c) Under normal working conditions, for a typical 4-hour dialysis treatment, the display error of the cumulative net dehydration volume of the equipment shall not exceed ±400mL.
NOTE: The net dehydration rate control error and cumulative net dehydration volume error for underweight patients are determined by the manufacturer's risk analysis. 5.2.3.2 Net dehydration deviation
For a typical 4-hour dialysis treatment, at any time during the treatment period, the difference between the actual cumulative net dehydration volume and the expected cumulative net dehydration volume shall be within ±400mL.
NOTE: The net dehydration deviation error for underweight patients is determined by the manufacturer's risk analysis.
5.2.3.3 Safety of net dehydration
When the equipment is running, the following provisions shall be satisfied to ensure the safety of net dehydration:
a) The equipment shall display real-time net dehydration parameters and completed net dehydration volume;
b) The settings of net dehydration parameters shall be confirmed.
5.2.4 Replacement fluid flow error
For online equipment, the equipment's replacement fluid flow control range and control error shall comply with the manufacturer's specifications.
NOTE: Replacement fluid flow below the set value is considered detrimental to typical treatment. 5.2.5 Control and protection of heparin pump
b) Unless additional protective measures are determined by the risk management process, the equipment shall be able to detect the integrity of the non-disposable filtration sterilization system before treatment;
c) It shall be ensured that the recommended disinfection procedures do not affect the performance of the filtration-sterilization system.
NOTE 1: The filtrate of the filtration-sterilization system may not necessarily meet the quality requirements of the final replacement fluid.
NOTE 2: If necessary, the filtration performance of a single filter can be tested offline. 5.5 Control and protection of dialysate conductivity
5.5.1 Resolution and indication error
The resolution and indication error of the equipment shall comply with the following provisions: a) The display resolution shall be no greater than 0.1mS/cm;
b) The indication error shall comply with the manufacturer's specifications. 5.5.2 Conductivity control function
The conductivity control function of the equipment shall comply with the following provisions: a) The conductivity control error shall comply with the manufacturer's specifications; b) If the equipment is equipped with dialysate conductivity feedback control function, then: --- The equipment control system shall be equipped with at least one dialysate conductivity measuring device that is independent of any protection system; --- Under normal circumstances, when the measured value of dialysate conductivity deviates from the expected value, the conductivity feedback control function shall be able to ensure that the conductivity control error meets the requirements of 5.5.2 a).
5.5.3 Conductivity protection function
The conductivity protection function of the equipment shall comply with the following provisions:
a) The equipment protection system shall be equipped with at least one dialysate conductivity measuring device independent of any control system;
b) The equipment shall test the effectiveness of the conductivity measuring device of the protection system:
--- Each time before entering treatment mode, the equipment shall be able to test the effectiveness of the conductivity measuring device of the protection system, or --- Conduct an effectiveness test at least once a day before entering the treatment mode, and measures shall be taken to ensure the continued effectiveness of the conductivity measuring device of the protection system during the treatment process. c) During treatment, when the measured value of the dialysate conductivity measuring device of the protection system exceeds the alarm limit, the equipment shall activate audible and visual alarm signals to prevent the flow of dialysate to the dialyzer (or filter), and (or) prevent replacement fluid from flowing into the blood; and the conductivity value measured at the dialyzer inlet when alarming does not exceed ±5% of the expected value;
d) During the treatment process, the conductivity over-limit protection function is not allowed to be turned off;
e) The equipment shall have measures to prevent misplacement of dialysate concentrate; f) If the equipment is equipped with a dialysate conductivity feedback control function, the equipment shall also have protection measures independent of the feedback control system. After the concentration of the concentrated solution exceeds the range specified by the manufacturer, the equipment shall stop feedback control and activate the audible visual alarm signal; and prevent the dialysate from flowing to the dialyzer (or filter), and/or prevent the replacement fluid from flowing into the blood.
NOTE: Unlimited feedback control of dialysate conductivity may be risky. 5.6 Temperature control
5.6.1 Temperature control range and error
5.6.1.1 Dialysate temperature control range and error
The dialysate temperature control range and error of the equipment shall comply with the following provisions:
a) The dialysate temperature control range shall comply with the manufacturer's specifications. Unless reasonably justified during the manufacturer's risk management process, the dialysate temperature control range shall not exceed 33°C~42°C; b) The dialysate temperature control error shall comply with the manufacturer's specifications, and the temperature control error within the range of 35 ℃ ~ 38 ℃ shall not exceed ±0.5 ℃.
5.6.1.2 Replacement fluid temperature control range and error
b) There shall be high and low limit alarms, and the alarm value tolerance shall comply with the manufacturer's provisions.
c) In treatment mode, when the arterial pressure exceeds the alarm limit, the equipment shall activate audible and visual alarm signals, stop the blood pump operation, and/or prevent replacement fluid from flowing into the blood, and reduce ultrafiltration to a minimum. 5.8 Dialysate flow, temperature and conductivity stability
The working performance of the equipment shall be stable and meet the following requirements during 4 hours of continuous operation:
a) Dialysate flow fluctuation ≤10%;
b) Dialysate temperature fluctuation ≤1°C;
c) Dialysate conductivity fluctuation ≤1mS/cm.
5.9 Blood leakage protection system
The equipment shall be equipped with a blood leakage protection system. Under the specified maximum dialysate flow, ultrafiltration flow, and replacement fluid flow (if applicable), the maximum alarm limit of the blood leakage rate shall be ≤0.35mL/min [hematocrit of blood (Hct) is 32%], the protection system shall be able to activate audible and visual alarm signals and prevent further leakage of blood into the dialysate.
5.10 Prevent air from entering
5.10.1 Air detection measures
Equipment shall have air detection measures to prevent air from entering the patient: --- Air detection measures against the detection sensitivity of large volumes of air shall comply with the manufacturer's specifications. When the value specified by the manufacturer is exceeded, the device shall activate audible and visual alarm signals and prevent blood flow to the patient.
--- Air detection measures shall have the function of detecting continuous air entry. 5.10.2 Prevent air from entering the patient
The equipment shall be capable of preventing the entry of large volumes of air and continuous air in excess of the manufacturer's specifications from entering the patient, and safeguards shall be capable of activating audible and visual alarm signals and preventing blood flow to the patient.
NOTE 1: If the arterial line has a blood return function, there is also a risk of air entering the patient, including large volumes of air and continuous air.
NOTE 2: The bubble detection method and the liquid level detection method can be used to detect large volumes of air and continuous air entry. If either of them cannot be used alone to detect large volumes of air and continuous air, they can be used in combination.
5.11 pH measuring device
If the equipment has a pH measuring device, the measurement error of the equipment's pH measuring device shall comply with the manufacturer's specifications.
5.12 Network power supply interruption
The network power supply interruption function of the equipment shall comply with the following provisions:
a) When the network power supply is interrupted, the equipment shall be able to ensure that the blood pump during the treatment process continues to work for no less than 15 min; and the blood circuit system shall continue to maintain working status; NOTE: The blood circuit system includes blood pumps, heparin pumps, blood circuit protection systems, veinous clamps, etc.
b) The equipment shall be able to prevent accidental shutdown caused by mis-operation of switches other than the mains power switch during treatment.
5.13 Degassing function
The equipment shall have a degassing function for water or liquid inlet. 5.14 Waste liquid protection
The equipment's waste system shall prevent used waste fluid from flowing back into the dialyzer.
5.15 Disinfection
5.15.1 General requirements
The equipment shall ensure that the dialysate pipeline is disinfected without dead zones. 5.15.2 Thermal disinfection
If the equipment has a thermal disinfection function, it shall comply with the following provisions:
a) The manufacturer should specify the thermal disinfection parameters for the inner surfaces of each part of the dialysate pipeline of the equipment, including: c) The equipment shall have the function of monitoring abnormal effective concentration of disinfectant and/or abnormal temperature. When an abnormality occurs, the equipment shall activate audible and visual alarm signals at least before entering the next treatment; d) The equipment shall have the function of monitoring the integrity of the disinfection program. When the disinfection program is unexpectedly interrupted and the disinfection program is not completed:
--- The equipment shall start the flushing process and prompt that the disinfection is not completed;
--- Or re-disinfect;
e) After disinfection is completed, the residual amount of disinfectant shall comply with the manufacturer's specifications;
f) If the equipment uses different suction inlets to inhale different disinfectants, measures shall be taken to prevent incorrect connection of the disinfectants.
NOTE 2: Disinfectant refers to the original solution before dilution, and disinfectant refers to the solution diluted to achieve an effective disinfection concentration.
NOTE 3: The activity of sodium hypochlorite and peracetic acid increases with temperature, but too high a temperature may cause the disinfectant to degrade, weaken its bactericidal activity, and may produce harmful substances.
5.16 Operating noise
There shall be no abnormal noise when the equipment is working, and the noise shall be no greater than 62dB (A-weighted).
NOTE: Abnormal noise does not include alarm sounds.
5.17 Appearance and structure
The appearance and structure of the equipment shall comply with the following provisions: a) The appearance of the equipment shall be correct, the surface shall be clean, the color shall be uniform, and there shall be no defects such as scratches or cracks; b) The panel of the equipment shall be free of coating peeling and rust, and the words and signs on the panel shall be clearly visible;
c) The plastic parts of the equipment shall be free from blistering, cracking, deformation and spillage of filling material;
d) The control and adjustment mechanism of the equipment shall be flexible and reliable, 6.2 Flow control test
6.2.1 Blood flow error test
Compliance is checked under the following test conditions:
a) When the equipment is running in treatment mode, the actual blood flow control range of the equipment shall meet the requirements of 5.2.1 a);
b) Carry out the test as follows:
Test 1:
--- Install the unused pump pipe section to the equipment according to the instruction manual and let it run for at least 30 min;
--- Inject 37℃ liquid (for example: water) into the extracorporeal pipeline; --- Set the blood flow of the equipment to 400mL/min, or if not possible, to the maximum possible blood flow;
--- Adjust the pre-pump arterial pressure to -200mmHg;
--- Measure blood flow 3 times, each measurement takes 3 min; and if applicable, record the value displayed by the device at the same time;
--- Calculate the arithmetic mean of three actual measurement values as the measurement value;
--- The control error calculated from the measured value and the set value shall meet the requirements of 5.2.1 b);
--- If applicable, the display error calculated from the equipment display value and the measured value shall meet the requirements of 5.2.1 c);
Continue to test 2:
--- Set the equipment’s blood flow to the midpoint of the nominal range; --- Set the pre-pump arterial pressure to -200mmHg;
--- Measure blood flow 3 times, each measurement takes 3 min; and if applicable, record the value displayed by the equipment at the same time;
--- Calculate the arithmetic mean of three actual measurement values as the measurement value;
--- The control error calculated from the measured value and the set value shall meet the