YY 0054-2003 Hemodialysis, hemodiafiltration and hemofiltration equipment
Some standard content:
All technical contents of this standard are mandatory. Foreword
This standard is a revision of the industry standard YY0054-1991 "Hemodialysis Device". The main technical differences between this standard and YY0054-1991 are as follows: "Hemodiafiltration and Hemofiltration" are added to the standard name. The temperature control accuracy requirements of the dialysate are improved. - Add arterial pressure requirements and test methods
- Add blood pump, replacement fluid pump and heparin pump flow monitoring requirements and test methods. - Add pH monitoring requirements and test methods. Add ultrafiltration dehydration accuracy requirements and test methods-The pressure change of working performance stability is changed to only apply to pressure-controlled dialysis machines. The requirements for electroplated parts and painted parts in the original standard are changed to requirements for appearance. The requirements for the maximum dialysate flow rate and the requirements for the dialysate pressure adjustment range are deleted. YY0054-2003
-This standard modifies the environmental test of the equipment according to GB/T14710-1993 "Environmental Requirements and Test Methods for Medical Electrical Equipment".
This standard replaces YY0054-1991 from the date of implementation. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment. The drafting unit of this standard: Guangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration. The main drafters of this standard: Chen Jiaye, Huang Xiulian, Yu Qinglan, Yang Xiaoling. This standard was first issued in October 1991. This standard is interpreted by the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment.
1 Scope
Hemodialysis, hemodiafiltration and hemofiltration equipment YY 0054--2003
This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, markings, instructions for use and packaging, transportation and storage of hemodialysis, hemodiafiltration and hemofiltration equipment. This standard applies to hemodialysis, hemodiafiltration and hemofiltration equipment (hereinafter referred to as equipment). It is not applicable to equipment for continuous renal replacement therapy (CRRT). 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties who reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated referenced documents, the latest versions are applicable to this standard. GB/T191 Packaging, storage and transportation pictorial marking
GB9706.2 Medical electrical equipment, special safety requirements for hemodialysis devices GB9969.1 General provisions for industrial product instructions GB/T13074 Blood purification terminology, hemodialyzer and hemofiltration GB/T14710—1993 Environmental requirements and test methods for medical electrical equipment GB/T16886.1-2001 Biological evaluation of medical devices Part 1: Evaluation and testing 3 Terms and definitions
This standard adopts the terms and definitions specified in GB9706.2 and GB13074. 4 Classification and marking
4.1 Classification
a) Liquid dialysis type;
b) Hemofiltration type;
c) Hemodiafiltration type.
4.2 Basic parameters
4.2.1 Dialysate flow rate
The maximum flow rate of dialysate shall not be less than 500mlL/min. 4.2.2 Temperature control range
The dialysate temperature shall be controlled within the range of 30℃～40℃. 4.2.3 Ultrafiltration method
a) Pressure control type;
b) Volume control type.
4.2.4 Liquid preparation method
Automatic liquid preparation:
b) Manual liquid preparation.
5 Requirements
5.1 Normal working conditions
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Normal working conditions shall meet the following requirements: a) Ambient temperature 10℃～30℃,
b) Relative humidity not more than 70%,
c) Atmospheric pressure 86kPa～106kPa,
d) Power supply:
1) AC: 220V±22V, 50Hz±1Hz; 2) DC: Under DC power supply conditions, the blood pump of the equipment can work continuously for more than 15min (if any), e) Water supply temperature 5℃～35℃ (if any); f) Water supply flow rate 500mL/min or more (if any). 5.2 Temperature control system
5.2.1 Temperature indication error
Adjustable within the nominal temperature control range, error range ±0.5℃. 5.2.2 Over-temperature alarm
There should be high and low limit alarms, and the alarm action error is ±0.5℃. When the alarm temperature preset value is exceeded, an audible and visual alarm should be issued to prevent the dialysate from flowing to the dialyzer (or filter) and (or) prevent the replacement fluid from flowing into the blood. 5.3 Pressure monitoring system
5.3.1 Venous pressure monitoring
Venous pressure monitoring should comply with the following regulations:
a) The indication accuracy is ±1.3kPa (±10mmHg); b) There should be high and low limit alarms, and the alarm action error is ±1.3kPa (soil 10mmHg); in the treatment mode, the low limit alarm shall not be lower than 1.3kPa (+10mmHg); c)
d) At the same time as the audible and visual alarm, the blood pump should be stopped, any replacement fluid flow should be interrupted, and ultrafiltration should be reduced to the minimum value. 5.3.2 Arterial pressure monitoring (if any)
Arterial pressure monitoring (if any) shall comply with the following provisions: a) The indication accuracy is ±1.3 kPa (±10 mmHg); b) There shall be high and low limit alarms, and the alarm action error is ±1.3 kPa (±10 mmHg). 5.3.3 Dialysate pressure monitoring or transmembrane pressure monitoring 5.3.3.1 Dialysate pressure monitoring shall comply with the following requirements: The indication accuracy is ±2.7 kPa (±20 mmHg) within the nominal range a)
b) Within the range of ±2.7 kPa (±20 mmHg) of the preset pressure alarm value, an audible and visual alarm shall be issued 5.3.3.2 Transmembrane pressure monitoring shall comply with the following requirements: a) The indication accuracy is ±2.7 kPa (±20 mmHg); b) Within the range of ±2.7 kPa (±20 mmHg) of the preset pressure alarm value, an audible and visual alarm shall be issued. 5.4 Flow monitoring
5.4.1 Dialysate flow monitoring
The dialysate flow L is within the nominal range, and its error range is L ± 10%. 5.4.2 Blood pump flow monitoring
It can be adjusted within the nominal range, and the error range is ± 10mL/min or ± 10% of the reading, whichever is greater. 5.4.3 Replacement fluid pump (supplementary fluid pump) flow monitoring (without) can be adjusted within the nominal range, and the error range is ± 5mL/min or ± 10% of the reading, whichever is greater. 5.4.4 Heparin pump injection flow monitoring
It can be adjusted within the nominal range, and the error range is ± 0.2mL/h or ± 5% of the reading, whichever is greater. 5.5 pH value monitoring (if any)
The indication accuracy is ±0.1 within the nominal range. 5.6 Weighing scale (if any)
Within the nominal range, the error range of the weighing scale is ±5.0g or ±0.5% of the reading, whichever is greater. 5.7 Dehydration accuracy
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Within the specified ultrafiltration range, the dehydration accuracy of the equipment should be ±30mL/h or ±1% of the reading, whichever is greater. 5.8 Stability
The working performance of the equipment should be stable, and in continuous operation for 6 hours, the following requirements should be met: a) The change in dialysate flow rate is ≤10%;
b) The change in temperature is ≤1℃;
c) The change in dialysis pressure is ≤10% (applicable to pressure-controlled dialysis type). 5.9 Alarm
5.9.1 Dialysate concentration protection system
Equipment with automatic liquid preparation should have a dialysate concentration protection system independent of any liquid preparation control system. When the dialysate concentration exceeds the conductivity preset value ± 5%, an audible and visual alarm should be issued, and the dialysate should be prevented from entering the dialyzer (or filter). 5.9.2 Blood leakage protection system
The equipment should have a blood leakage protection system. At the maximum specified dialysate flow rate, when the blood leakage in each liter of dialysate is ≥1mL, the equipment should issue an audible and visual alarm, stop the blood pump operation, and interrupt any replacement fluid flow to reduce ultrafiltration to the minimum value. 5.9.3 Protection system to prevent air from entering the blood pipeline The equipment should have a protection system to prevent air from entering the blood pipeline and meet the following requirements: a) A protection system using a bubble detector. When a single bubble with a volume of not less than 200u appears in the venous blood circuit at a standard blood flow of 200mL/min, an audible and visual alarm should be issued, the blood pump should be stopped, and the venous blood pipeline should be blocked. b) A protection system using an air trap liquid level detector. When the blood level in the air trap is lower than the lower end of the detector, an audible and visual alarm should be issued, the blood pump should be stopped, and the venous blood pipeline should be blocked. 5.9.4 Heparin pump protection system
The equipment should have a heparin pump protection system. When the heparin injection is completed, the equipment should issue an audible and visual alarm or other prompts. 5.10 Degassing protection
The hemodialysis equipment should have a dialysate degassing device. 5.11 Waste liquid protection
The waste liquid system of the single-pass hemodialysis equipment should be able to prevent the used waste liquid from flowing from the outlet to the dialyzer. 5.12 Disinfection protection
During the cleaning, sterilization or disinfection operation of the equipment, patients cannot be treated, and there should be obvious instructions or warnings. 5.13 Leakage
The pipes, joints and containers of the equipment shall not leak. 5.14 Biological properties of liquid pipeline system
The biological properties of the materials used in the liquid pipeline system of the equipment shall be biologically evaluated in accordance with the provisions of GB/T16886.1-2001. 5.15 Working noise
When the equipment is working, there shall be no abnormal noise, and the noise shall not be greater than 62dB (A-weighted). 5.16 Alarm signal sound
The alarm sound pressure level of the equipment shall not be less than 65dB (A-weighted). 5.17 Appearance and structure
5.17.1 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 and cracks. 5.17.2 The panel of the equipment should not have any coating peeling or rust, and the text and logo on the panel should be clearly visible. 5.17.3 The plastic parts of the equipment should not have any blistering, cracking, deformation, or overflow of the filling material. 3
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5.17.4 The control and adjustment mechanism of the equipment should be flexible and reliable, and the fasteners should not be loose. 5.18 Safety requirements
Safety requirements should meet the requirements of GB9706.2. 5.19 Environmental test
5.19.1 Environmental test requirements for equipment should be carried out in accordance with the requirements specified in GB/T14710-1993, and the climatic environmental test should be Group I (except for rated temperature and wet heat working tests). 5.19.2 Mechanical environmental test should be Group I (except for vibration and collision tests). The transportation test should meet the requirements of Chapter 3 of GB/T14710--1993.
6 Test method
6.1 Test working conditions shall meet the requirements of 5.1. 6.2 Temperature control system test
6.2.1 Temperature indication error test
The dialysate (or replacement fluid) flow rate is adjusted to the rated working flow rate (if there is an optional rated working flow rate, take the midpoint of its nominal flow rate range), and the dialysate (or replacement fluid) temperature is adjusted to the high, medium and low points of the temperature control range. When it is stable, use a temperature measuring instrument with a graduation value of 0.1℃ to measure the temperature at the outlet of the dialysate (or replacement fluid) of the equipment, which shall meet the requirements of 5.2.1. 6.2.2 Overtemperature alarm test
Set the alarm temperature of the dialysate (or replacement fluid), and adjust the dialysate (or replacement fluid) temperature to stabilize to the alarm temperature. Observe the difference between the temperature indication value and the alarm preset value and the alarm action status during the alarm, which shall meet the requirements of 5.2.2. 6.3 Pressure monitoring test
6.3.1 Venous pressure monitoring test
The venous pressure monitoring test shall comply with the following provisions: a) Within the specified range, monitor with a standard pressure detector, and the maximum error of its indication accuracy shall comply with the requirements of 5.3.1a); b) Set the preset alarm value, and then use a syringe to perform a pressurization test, and the alarm value error and alarm action status shall comply with the requirements of 5.3.1b) and d);
c) In the treatment mode, observe the venous pressure alarm limit setting range, which shall comply with the requirements of 5.3.1c). 6.3.2 Arterial pressure monitoring test
The arterial pressure monitoring test shall comply with the following provisions: a) Within the specified range, monitor with a standard pressure detector, and the maximum error of its indication accuracy shall comply with the requirements of 5.3.2a); b) Set the preset alarm value, and then use a syringe to perform a negative pressure test, and the alarm value error shall comply with the requirements of 5.3.2b). 6.3.3 Dialysate pressure monitoring test
The dialysate pressure monitoring test shall comply with the following provisions: a) Under the condition of ensuring that the dialysate flow rate is 500mL/min, adjust the dialysate pressure to the low, medium and high points of the nominal pressure range. After stabilization, use a standard pressure measuring instrument to measure the dialysate pressure. The error shall comply with the requirements of 5.3.3.1a); b) When the pressure exceeds the preset alarm value, the alarm value error and alarm action state shall comply with the requirements of 5.3.3.1b). 6.3.4 Transmembrane pressure monitoring test
6.3.4.1 When the blood pipeline pressure is stable at a certain value, through the test of 6.3.3, according to the following definition (or the definition of transmembrane pressure in the document approved by the manufacturer's specified procedures): a) The difference between the arithmetic mean of the blood chamber outlet and the arithmetic mean of the dialysate chamber outlet of the dialyzer, or b) The difference between the arithmetic mean of the blood chamber outlet pressure and the filtrate pressure of the blood filter or hemoconcentrator. Calculate the transmembrane pressure, and its error shall meet the requirements of 5.3.3.2a). 6.3.4.2 When the pressure exceeds the preset alarm value, its alarm value error and alarm action status shall meet the requirements of 5.3.3.2b). 6.4 Flow monitoring test
6.4.1 Dialysate flow monitoring test
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Adjust the dialysate flow to low, medium and high levels respectively. After it stabilizes, use a special instrument or timed measurement method to measure the flow for 3 minutes. Measure three times respectively and take the arithmetic mean. The maximum error shall meet the requirements of 5.4.1. 6.4.2 Blood pump and replacement fluid pump flow monitoring test Within the nominal range, adjust the flow of the blood pump and replacement fluid pump to low, medium and high levels respectively. After stabilization, use a special instrument or timing measurement method to measure the flow for 3 minutes. Measure three times respectively and take the arithmetic mean. The maximum error should meet the requirements of 5.4.2~5.4.3. 6.4.3 Heparin pump injection flow monitoring test
Within the nominal range, adjust the flow of the heparin pump to the maximum. After stabilization, use a special instrument or timing measurement method to measure the flow for 30 minutes. The error should meet the requirements of 5.4.4. 6.5 pH value monitoring test
The volume measurement method can be used to obtain the appropriate concentrate dilution solution. The pH value of the dialysate is measured with a special instrument. The result should meet the requirements of 5.5.
6.6 Weighing meter test
When empty and with 2kg and 4kg standard magnetic codes, the weighing meter reading should meet the requirements of 5.6. 6.7 Ultrafiltration accuracy test
Connect the dialyzer and blood circuit according to the treatment working mode, and immerse the arteriovenous end of the blood circuit in a container filled with water. After the blood circuit is filled with water, use an electronic scale with an accuracy of no more than 1g to measure the water volume in the container. When the flow reaches a stable state, set high and low ultrafiltration speeds within the nominal ultrafiltration range, measure the dehydration amount, and its maximum error should meet the requirements of 5.7.
6.8 Dialysis fluid flow, pressure, and temperature stability test When the power supply voltage changes by no more than 5V, the ambient temperature changes by no more than 5℃, and the inlet temperature changes by no more than 2℃, adjust the equipment to the normal working range. After stabilization, run it continuously for 6 hours, and record the flow, temperature, and pressure of the dialysate every 30 minutes. The range of changes should meet the requirements of 5.8.
6.9 Alarm test
6.9.1 Dialysate concentration protection system test
Inject the dialysate with a concentration deviation from the set concentration into the dialysate circuit and observe the concentration protection function of the equipment. Its alarm action should meet the requirements of 5.9.1.
6.9.2 Blood protection system test
Inject fresh human (bovine) blood with a hematocrit adjusted to 0.32±0.02 and physiological saline into the container at a ratio of 1:1000; adjust the dialysate flow rate of the equipment to the maximum and enter the dialysis state, put the dialyzer dialysate outlet pipe into the container, and when the test liquid flows through the blood leakage detector, observe the alarm action of the protection system. The result should meet the requirements of 5.9.2. 6.9.3 Test of the protection system to prevent air from entering the blood pipeline The test of the protection system to prevent air from entering the blood pipeline shall comply with the following provisions: a) At a standard flow rate of 200 ml./min, use a syringe to inject bubbles with a volume of 200 μl. into the blood pipeline and observe the alarm action of the protection system. The result shall comply with 5.9.3a) requirements; In the blood pipeline at a standard flow rate of 200mL/min, inject air into the air trap with a syringe and observe the drop of the liquid level in the air trap. When the liquid level is lower than the lower end of the detector, observe the alarm action of the protection system. The result should meet the requirements of 5.9.3b).
6.9.4 Heparin pump protection system test
Start the heparin pump and observe the alarm action when the heparin injection is completed. It should meet the requirements of 5.9.4. 6.10 Degassing protection test
Determine whether there is a dialysate degassing device through observation and whether it has a degassing function. It should meet the requirements of 5.10. 6.11 Waste liquid protection test
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Confirmed by checking relevant technical documents and circuit diagrams. It should meet the requirements of 5.11. 6.12 Disinfection protection test
Determine whether there are relevant obvious indications through observation, and ensure that patients cannot be treated during the disinfection period, which should meet the requirements of 5.12. 6.13 Leakage test
In the treatment working state, observe the pipes, joints and containers of the equipment. No leakage should occur within 5 minutes. 6.14 Biological performance test of liquid pipeline system Biological performance evaluation shall be carried out in accordance with the provisions of GB/T16886.1-2001, and the results shall meet the requirements of 5.14. 6.15 Working noise test
Start each pump. Under normal working conditions, the sound level meter is 1m away from the surface of the equipment and 1m above the ground. The sound pressure level at the front, back, left and right points is measured using the A-weighted network. The maximum value shall meet the requirements of 5.15. 6.16 Alarm signal sound test
Put the equipment in alarm state, and use the sound level meter to measure the sound pressure level at the front, rear, left and right points at 1m from the surface of the equipment and 1m above the ground using the A-weighted network. The minimum value shall meet the requirements of 5.16. 6.17 Appearance and structure test
Visual observation and actual operation inspection shall meet the requirements of 5.17. 6.18 Safety requirement test
Perform according to the method specified in GB9706.2.
6.19 Environmental test
The environmental test of the equipment shall be carried out in accordance with the relevant provisions of GB/T14710-1993 and the provisions of Table 1, and shall meet the provisions of 5.19.
Test requirements
Test items
Low-temperature storage
High-temperature storage
Storage test
Wet-heat storage
Transportation test
Test in box
Test time in box
Duration time
Recovery time
1 (or specified by the enterprise
standard)
(or specified by the enterprise
standard)
(or specified by the enterprise
standard)
Normal packaging state
Test items
Intermediate and final inspection
Initial inspection
Full performance
(Except 5.19)
AC 220 V
Power adaptability test
AC242 V
5.2.1、5.3.15.2.1、5.3.1、
5.2. 1,5. 3. 1、
5.2.1、5.3.1、
5.2.1、5.3.1、
Full performance
(Except 5.14、
5.18)
Note: The low temperature storage test temperature of equipment with LCD display can be set by the enterprise itself, and the recommended temperature is -20℃. 6
7 Inspection rules
7.1 Inspection classification
7.1.1 The equipment should be inspected by the quality inspection department of the manufacturer, and only qualified equipment can be submitted for inspection and acceptance. 7.1.2 The quality inspection of equipment is divided into factory inspection and type inspection. 7.1.3 Inspections that must be carried out for factory inspection. 7. 1.4
Type inspection shall be carried out in any of the following situations: a)
Registration inspection before new products are put into production;
No less than once a year in continuous production;
When the equipment is put into production again after an interval of more than one year;
When there are major changes in design, process or materials; When the factory inspection results are significantly different from the last type inspection; When the national quality supervision agency proposes a supervision and random inspection requirement. 7.2 Inspection items
The factory inspection items of equipment are shown in Table 2.
Inspection classification
Factory inspection
Type inspection
Safety performance
Main performance
General performance
Safety performance
Main performance
General performance
Inspection items
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5.2~5.16, 5.19
5. 17, 8. 1
7.2.2 The type inspection items of equipment are shown in Table 2. For type inspection, samples are taken from the products that have passed the factory inspection for inspection. 7.3 Sampling method and quantity
The sampling method and quantity for factory inspection and type inspection are shown in Table 3. 7.4 Judgment rules and re-inspection rules
The judgment rules and re-inspection rules for factory inspection and type inspection are shown in Table 3. Table 3
Inspection classification
Factory inspection
Type inspection
Sampling method and quantity
Each product leaving the factory
Sampling method: sealed sample
Quantity: 1 unit
Judgment rules
If any of the inspection items are not met, the product is unqualified. If any of the safety performance and main performance inspection items are not met, the product is unqualified. If any two items of the general performance requirements are not met, the product is unqualified.
Marking, instruction manual, packaging, transportation, storage 8.1 Marking
8.1.1 Each equipment should be fixed with a nameplate in an appropriate and obvious position. The nameplate should have the following markings: a) Name of the manufacturer;
Product name and model;
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c) Input power, power supply voltage, frequency; d) Factory number;
e) Registered product standard number, product registration number. 8.1.2 Each equipment should be accompanied by a certificate of inspection, instruction manual and packing list. The certificate of inspection should have the following markings: a) Name of the manufacturer;
b) Product name and model;
c) Inspection date;
Inspector code.
8.1.3 The packaging box should have the following marks:
a) manufacturer name, address, postal code; b) product name, model;
factory date or batch number;
d) quantity;
e) net weight, gross weight;
volume (length × width × height);
registered product standard number, product registration number, production license number; h) "fragile items", "upward", "afraid of rain" and other words or signs. The markings should comply with the relevant provisions of GB/T191. The words or signs on the box should be guaranteed not to be blurred due to long-term use. 8.2 Instructions for use
The preparation of the instructions for use should comply with the relevant provisions of GB9969.1. 8.3 Packaging
8.3.1 The exposed electroplated surfaces of the equipment, accessories and tools should be coated with neutral rust inhibitors as needed and packaged with neutral packaging paper or plastic film.
8.3.2 All water in equipment pipelines and containers should be drained before packing. 8.3.3 Each equipment should be packed in a packing box, which should be equipped with moisture-proof and rain-proof devices to ensure that the equipment is not damaged by nature. 8.3.4 Equipment, accessories and tools must be firmly positioned in the box to prevent loosening and mutual friction during transportation. 8.4 Transportation
Transportation shall be in accordance with the contract.
The packaged equipment should be stored in a well-ventilated room with a relative humidity not exceeding 80% and no corrosive gases. 813 Leakage test
In the treatment working state, observe the pipes, joints and containers of the equipment. No leakage shall occur within 5 minutes. 6. 14 Biological performance test of liquid pipeline system Biological performance evaluation shall be carried out in accordance with the provisions of GB/T16886.1-2001. The results shall meet the requirements of 5.14. 6.15 Working noise test
Start each pump. Under normal working conditions, the sound level meter is 1m away from the surface of the equipment and 1m above the ground. The sound pressure level of the front, rear, left and right points is measured using the A-weighted network. The maximum value shall meet the requirements of 5.15. 6.16 Alarm signal sound test
Put the equipment in the alarm state. The sound level meter is 1m away from the surface of the equipment and 1m above the ground. The sound pressure level of the front, rear, left and right points is measured using the A-weighted network. The minimum value shall meet the requirements of 5.16. 6.17 Appearance and structure test
Visual observation and actual operation inspection shall meet the requirements of 5.17. 6.18 Safety requirement test
Perform in accordance with the method specified in GB9706.2.
6.19 Environmental test
The environmental test of the equipment shall be carried out in accordance with the relevant provisions of GB/T14710-1993 and the provisions of Table 1, and shall meet the provisions of 5.19.
Test requirements
Test items
Low-temperature storage
High-temperature storage
Storage test
Wet-heat storage
Transportation test
Test in box
Test time in box
Duration time
Recovery time
1 (or specified by the enterprise
standard)
(or specified by the enterprise
standard)
(or specified by the enterprise
standard)
Normal packaging state
Test items
Intermediate and final inspection
Initial inspection
Full performance
(Except 5.19)
AC 220 V
Power adaptability test
AC242 V
5.2.1、5.3.15.2.1、5.3.1、
5.2. 1,5. 3. 1、
5.2.1、5.3.1、
5.2.1、5.3.1、
Full performance
(Except 5.14、
5.18)
Note: The low temperature storage test temperature of equipment with LCD display can be set by the enterprise itself, and the recommended temperature is -20℃. 6
7 Inspection rules
7.1 Inspection classification
7.1.1 The equipment should be inspected by the quality inspection department of the manufacturer, and only qualified equipment can be submitted for inspection and acceptance. 7.1.2 The quality inspection of equipment is divided into factory inspection and type inspection. 7.1.3 Inspections that must be carried out for factory inspection. 7. 1.4
Type inspection shall be carried out in any of the following situations: a)
Registration inspection before new products are put into production;
No less than once a year in continuous production;
When the equipment is put into production again after an interval of more than one year;
When there are major changes in design, process or materials; When the factory inspection results are significantly different from the last type inspection; When the national quality supervision agency proposes a supervision and random inspection requirement. 7.2 Inspection items
The factory inspection items of equipment are shown in Table 2.
Inspection classification
Factory inspection
Type inspection
Safety performance
Main performance
General performance
Safety performance
Main performance
General performance
Inspection items
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5.2~5.16, 5.19
5. 17, 8. 1
7.2.2 The type inspection items of equipment are shown in Table 2. For type inspection, samples are taken from the products that have passed the factory inspection for inspection. 7.3 Sampling method and quantity
The sampling method and quantity for factory inspection and type inspection are shown in Table 3. 7.4 Judgment rules and re-inspection rules
The judgment rules and re-inspection rules for factory inspection and type inspection are shown in Table 3. Table 3
Inspection classification
Factory inspection
Type inspection
Sampling method and quantity
Each product leaving the factory
Sampling method: sealed sample
Quantity: 1 unit
Judgment rules
If any of the inspection items are not met, the product is unqualified. If any of the safety performance and main performance inspection items are not met, the product is unqualified. If any two items of the general performance requirements are not met, the product is unqualified.
Marking, instruction manual, packaging, transportation, storage 8.1 Marking
8.1.1 Each equipment should be fixed with a nameplate in an appropriate and obvious position. The nameplate should have the following markings: a) Name of the manufacturer;
Product name and model;
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c) Input power, power supply voltage, frequency; d) Factory number;
e) Registered product standard number, product registration number. 8.1.2 Each equipment should be accompanied by a certificate of inspection, instruction manual and packing list. The certificate of inspection should have the following markings: a) Name of the manufacturer;
b) Product name and model;
c) Inspection date;
Inspector code.
8.1.3 The packaging box should have the following marks:
a) manufacturer name, address, postal code; b) product name, model;
factory date or batch number;
d) quantity;
e) net weight, gross weight;
volume (length × width × height);
registered product standard number, product registration number, production license number; h) "fragile items", "upward", "afraid of rain" and other words or signs. The markings should comply with the relevant provisions of GB/T191. The words or signs on the box should be guaranteed not to be blurred due to long-term use. 8.2 Instructions for use
The preparation of the instructions for use should comply with the relevant provisions of GB9969.1. 8.3 Packaging
8.3.1 The exposed electroplated surfaces of the equipment, accessories and tools should be coated with neutral rust inhibitors as needed and packaged with neutral packaging paper or plastic film.
8.3.2 All water in equipment pipelines and containers should be drained before packing. 8.3.3 Each equipment should be packed in a packing box, which should be equipped with moisture-proof and rain-proof devices to ensure that the equipment is not damaged by nature. 8.3.4 Equipment, accessories and tools must be firmly positioned in the box to prevent loosening and mutual friction during transportation. 8.4 Transportation
Transportation shall be in accordance with the contract.
The packaged equipment should be stored in a well-ventilated room with a relative humidity not exceeding 80% and no corrosive gases. 813 Leakage test
In the treatment working state, observe the pipes, joints and containers of the equipment. No leakage shall occur within 5 minutes. 6. 14 Biological performance test of liquid pipeline system Biological performance evaluation shall be carried out in accordance with the provisions of GB/T16886.1-2001. The results shall meet the requirements of 5.14. 6.15 Working noise test
Start each pump. Under normal working conditions, the sound level meter is 1m away from the surface of the equipment and 1m above the ground. The sound pressure level of the front, rear, left and right points is measured using the A-weighted network. The maximum value shall meet the requirements of 5.15. 6.16 Alarm signal sound test
Put the equipment in the alarm state. The sound level meter is 1m away from the surface of the equipment and 1m above the ground. The sound pressure level of the front, rear, left and right points is measured using the A-weighted network. The minimum value shall meet the requirements of 5.16. 6.17 Appearance and structure test
Visual observation and actual operation inspection shall meet the requirements of 5.17. 6.18 Safety requirement test
Perform in accordance with the method specified in GB9706.2.
6.19 Environmental test
The environmental test of the equipment shall be carried out in accordance with the relevant provisions of GB/T14710-1993 and the provisions of Table 1, and shall meet the provisions of 5.19.
Test requirements
Test items
Low-temperature storage
High-temperature storage
Storage test
Wet-heat storage
Transportation test
Test in box
Test time in box
Duration time
Recovery time
1 (or specified by the enterprise
standard)
(or specified by the enterprise
standard)
(or specified by the enterprise
standard)
Normal packaging state
Test items
Intermediate and final inspection
Initial inspection
Full performance
(Except 5.19)
AC 220 V
Power adaptability test
AC242 V
5.2.1、5.3.15.2.1、5.3.1、
5.2. 1,5. 3. 1、
5.2.1、5.3.1、
5.2.1、5.3.1、
Full performance
(Except 5.14、
5.18)
Note: The low temperature storage test temperature of equipment with LCD display can be set by the enterprise itself, and the recommended temperature is -20℃. 6
7 Inspection rules
7.1 Inspection classification
7.1.1 The equipment should be inspected by the quality inspection department of the manufacturer, and only qualified equipment can be submitted for inspection and acceptance. 7.1.2 The quality inspection of equipment is divided into factory inspection and type inspection. 7.1.3 Inspections that must be carried out for factory inspection. 7. 1.4
Type inspection shall be carried out in any of the following situations: a)
Registration inspection before new products are put into production;
No less than once a year in continuous production;
When the equipment is put into production again after an interval of more than one year;
When there are major changes in design, process or materials; When the factory inspection results are significantly different from the last type inspection; When the national quality supervision agency proposes a supervision and random inspection requirement. 7.2 Inspection items
The factory inspection items of equipment are shown in Table 2.
Inspection classification
Factory inspection
Type inspection
Safety performance
Main performance
General performance
Safety performance
Main performance
General performance
Inspection items
YY 0054—2003
5.2~5.16, 5.19
5. 17, 8. 1
7.2.2 The type inspection items of equipment are shown in Table 2. For type inspection, samples are taken from the products that have passed the factory inspection for inspection. 7.3 Sampling method and quantity
The sampling method and quantity for factory inspection and type inspection are shown in Table 3. 7.4 Judgment rules and re-inspection rules
The judgment rules and re-inspection rules for factory inspection and type inspection are shown in Table 3. Table 3
Inspection classification
Factory inspection
Type inspection
Sampling method and quantity
Each product leaving the factory
Sampling method: sealed sample
Quantity: 1 unit
Judgment rules
If any of the inspection items are not met, the product is unqualified. If any of the safety performance and main performance inspection items are not met, the product is unqualified. If any two items of the general performance requirements are not met, the product is unqualified.
Marking, instruction manual, packaging, transportation, storage 8.1 Marking
8.1.1 Each equipment should be fixed with a nameplate in an appropriate and obvious position. The nameplate should have the following markings: a) Name of the manufacturer;
Product name and model;
YY 0054—2003
c) Input power, power supply voltage, frequency; d) Factory number;
e) Registered product standard number, product registration number. 8.1.2 Each equipment should be accompanied by a certificate of inspection, instruction manual and packing list. The certificate of inspection should have the following markings: a) Name of the manufacturer;
b) Product name and model;
c) Inspection date;
Inspector code.
8.1.3 The packaging box should have the following marks:
a) manufacturer name, address, postal code; b) product name, model;
factory date or batch number;
d) quantity;
e) net weight, gross weight;
volume (length × width × height);
registered product standard number, product registration number, production license number; h) "fragile items", "upward", "afraid of rain" and other words or signs. The markings should comply with the relevant provisions of GB/T191. The words or signs on the box should be guaranteed not to be blurred due to long-term use. 8.2 Instructions for use
The preparation of the instructions for use should comply with the relevant provisions of GB9969.1. 8.3 Packaging
8.3.1 The exposed electroplated surfaces of the equipment, accessories and tools should be coated with neutral rust inhibitors as needed and packaged with neutral packaging paper or plastic film.
8.3.2 All water in equipment pipelines and containers should be drained before packing. 8.3.3 Each equipment should be packed in a packing box, which should be equipped with moisture-proof and rain-proof devices to ensure that the equipment is not damaged by nature. 8.3.4 Equipment, accessories and tools must be firmly positioned in the box to prevent loosening and mutual friction during transportation. 8.4 Transportation
Transportation shall be in accordance with the contract.
The packaged equipment should be stored in a well-ventilated room with a relative humidity not exceeding 80% and no corrosive gases. 819)
ac 220 V
power adaptability test
ac242 V
5.2.1, 5.3.15.2.1, 5.3.1,
5.2.1, 5.3.1,
5.2.1, 5.3.1,
full performance
(except 5.14,
5.18)
Note: The low temperature storage test temperature of equipment with LCD display can be set by the enterprise, and the recommended temperature is -20℃. 6
7 Inspection rules
7.1 Inspection classification
7.1.1 The equipment should be inspected by the quality inspection department of the manufacturer, and only qualified ones can be submitted for inspection and acceptance. 7.1.2 Equipment quality inspection is divided into factory inspection and type inspection. 7.1.3 Inspections that must be carried out for factory inspection. 7. 1.4
Type inspection should be carried out in any of the following situations: a)
Registration inspection before new products are put into production;
No less than once a year in continuous production;
When the equipment is put into production again after an interval of more than one year;
When there are major changes in design, process or materials; When the factory inspection results are significantly different from the last type inspection; When the national quality supervision agency proposes a supervision and random inspection requirement. 7.2 Inspection items
See Table 2 for the factory inspection items of equipment.
Inspection classification
Factory inspection
Type inspection
Safety performance
Main performance
General performance
Safety performance
Main performance
General performance
Inspection items
YY 0054—2003
5.2~5.16, 5.19
5. 17, 8. 1
7.2.2 The type inspection items of equipment are shown in Table 2. For type inspection, samples are taken from the products that have passed the factory inspection for inspection. 7.3 Sampling method and quantity
The sampling method and quantity for factory inspection and type inspection are shown in Table 3. 7.4 Judgment rules and re-inspection rules
The judgment rules and re-inspection rules for factory inspection and type inspection are shown in Table 3. Table 3
Inspection classification
Factory inspection
Type inspection
Sampling method and quantity
Each product leaving the factory
Sampling method: sealed sample
Quantity: 1 unit
Judgment ruleswww.bzxz.net
If any of the inspection items are not met, the product is unqualified. If any of the safety performance and main performance inspection items are not met, the product is unqualified. If any two items of the general performance requirements are not met, the product is unqualified.
Marking, instruction manual, packaging, transportation, storage 8.1 Marking
8.1.1 Each equipment should be fixed with a nameplate in an appropriate and obvious position. The nameplate should have the following markings: a) Name of the manufacturer;
Product name and model;
YY 0054—2003
c) Input power, power supply voltage, frequency; d) Factory number;
e) Registered product standard number, product registration number. 8.1.2 Each equipment should be accompanied by a certificate of inspection, instruction manual and packing list. The certificate of inspection should have the following markings: a) Name of the manufacturer;
b) Product name and model;
c) Inspection date;
Inspector code.
8.1.3 The packaging box should have the following marks:
a) manufacturer name, address, postal code; b) product name, model;
factory date or batch number;
d) quantity;
e) net weight, gross weight;
volume (length × width × height);
registered product standard number, product registration number, production license number; h) "fragile items", "upward", "afraid of rain" and other words or signs. The markings should comply with the relevant provisions of GB/T191. The words or signs on the box should be guaranteed not to be blurred due to long-term use. 8.2 Instructions for use
The preparation of the instructions for use should comply with the relevant provisions of GB9969.1. 8.3 Packaging
8.3.1 The exposed electroplated surfaces of the equipment, accessories and tools should be coated with neutral rust inhibitors as needed and packaged with neutral packaging paper or plastic film.
8.3.2 All water in equipment pipelines and containers should be drained before packing. 8.3.3 Each equipment should be packed in a packing box, which should be equipped with moisture-proof and rain-proof devices to ensure that the equipment is not damaged by nature. 8.3.4 Equipment, accessories and tools must be firmly positioned in the box to prevent loosening and mutual friction during transportation. 8.4 Transportation
Transportation shall be in accordance with the contract.
The packaged equipment should be stored in a well-ventilated room with a relative humidity not exceeding 80% and no corrosive gases. 819)
ac 220 V
power adaptability test
ac242 V
5.2.1, 5.3.15.2.1, 5.3.1,
5.2.1, 5.3.1,
5.2.1, 5.3.1,
full performance
(except 5.14,
5.18)
Note: The low temperature storage test temperature of equipment with LCD display can be set by the enterprise, and the recommended temperature is -20℃. 6
7 Inspection rules
7.1 Inspection classification
7.1.1 The equipment should be inspected by the quality inspection department of the manufacturer, and only qualified ones can be submitted for inspection and acceptance. 7.1.2 Equipment quality inspection is divided into factory inspection and type inspection. 7.1.3 Inspections that must be carried out for factory inspection. 7. 1.4
Type inspection should be carried out in any of the following situations: a)
Registration inspection before new products are put into production;
No less than once a year in continuous production;
When the equipment is put into production again after an interval of more than one year;
When there are major changes in design, process or materials; When the factory inspection results are significantly different from the last type inspection; When the national quality supervision agency proposes a supervision and random inspection requirement. 7.2 Inspection items
See Table 2 for the factory inspection items of equipment.
Inspection classification
Factory inspection
Type inspection
Safety performance
Main performance
General performance
Safety performance
Main performance
General performance
Inspection items
YY 0054—2003
5.2~5.16, 5.19
5. 17, 8. 1
7.2.2 The type inspection items of equipment are shown in Table 2. For type inspection, samples are taken from the products that have passed the factory inspection for inspection. 7.3 Sampling method and quantity
The sampling method and quantity for factory inspection and type inspection are shown in Table 3. 7.4 Judgment rules and re-inspection rules
The judgment rules and re-inspection rules for factory inspection and type inspection are shown in Table 3. Table 3
Inspection classification
Factory inspection
Type inspection
Sampling method and quantity
Each product leaving the factory
Sampling method: sealed sample
Quantity: 1 unit
Judgment rules
If any of the inspection items are not met, the product is unqualified. If any of the safety performance and main performance inspection items are not met, the product is unqualified. If any two items of the general performance requirements are not met, the product is unqualified.
Marking, instruction manual, packaging, transportation, storage 8.1 Marking
8.1.1 Each equipment should be fixed with a nameplate in an appropriate and obvious position. The nameplate should have the following markings: a) Name of the manufacturer;
Product name and model;
YY 0054—2003
c) Input power, power supply voltage, frequency; d) Factory number;
e) Registered product standard number, product registration number. 8.1.2 Each equipment should be accompanied by a certificate of inspection, instruction manual and packing list. The certificate of inspection should have the following markings: a) Name of the manufacturer;
b) Product name and model;
c) Inspection date;
Inspector code.
8.1.3 The packaging box should have the following marks:
a) manufacturer name, address, postal code; b) product name, model;
factory date or batch number;
d) quantity;
e) net weight, gross weight;
volume (length × width × height);
registered product standard number, product registration number, production license number; h) "fragile items", "upward", "afraid of rain" and other words or signs. The markings should comply with the relevant provisions of GB/T191. The words or signs on the box should be guaranteed not to be blurred due to long-term use. 8.2 Instructions for use
The preparation of the instructions for use should comply with the relevant provisions of GB9969.1. 8.3 Packaging
8.3.1 The exposed electroplated surfaces of the equipment, accessories and tools should be coated with neutral rust inhibitors as needed and packaged with neutral packaging paper or plastic film.
8.3.2 All water in equipment pipelines and containers should be drained before packing. 8.3.3 Each equipment should be packed in a packing box, which should be equipped with moisture-proof and rain-proof devices to ensure that the equipment is not damaged by nature. 8.3.4 Equipment, accessories and tools must be firmly positioned in the box to prevent loosening and mutual friction during transportation. 8.4 Transportation
Transportation shall be in accordance with the contract.
The packaged equipment should be stored in a well-ventilated room with a relative humidity not exceeding 80% and no corrosive gases. 83 The packaging box should have the following marks:
a) manufacturer name, address, postal code; b) product name, model;
factory date or batch number;
d) quantity;
e) net weight, gross weight;
volume (length × width × height);
registered product standard number, product registration number, production license number; h) "fragile items", "upward", "afraid of rain" and other words or signs. The mark should comply with the relevant provisions of GB/T191. The words or signs on the box should be guaranteed not to be blurred due to a long period of time. 8.2 Instructions for use
The preparation of the instructions for use should comply with the relevant provisions of GB9969.1. 8.3 Packaging
8.3.1 The exposed electroplated surfaces of the equipment, accessories and tools should be coated with neutral rust inhibitors as needed and packaged with neutral packaging paper or plastic film.
8.3.2 All water in equipment pipelines and containers should be drained before packing. 8.3.3 Each equipment should be packed in a packing box, which should be equipped with moisture-proof and rain-proof devices to ensure that the equipment is not damaged by nature. 8.3.4 Equipment, accessories and tools must be firmly positioned in the box to prevent loosening and mutual friction during transportation. 8.4 Transportation
Transportation shall be in accordance with the contract.
The packaged equipment should be stored in a well-ventilated room with a relative humidity not exceeding 80% and no corrosive gases. 83 The packaging box should have the following marks:
a) manufacturer name, address, postal code; b) product name, model;
factory date or batch number;
d) quantity;
e) net weight, gross weight;
volume (length × width × height);
registered product standard number, product registration number, production license number; h) "fragile items", "upward", "afraid of rain" and other words or signs. The mark should comply with the relevant provisions of GB/T191. The words or signs on the box should be guaranteed not to be blurred due to a long period of time. 8.2 Instructions for use
The preparation of the instructions for use should comply with the relevant provisions of GB9969.1. 8.3 Packaging
8.3.1 The exposed electroplated surfaces of the equipment, accessories and tools should be coated with neutral rust inhibitors as needed and packaged with neutral packaging paper or plastic film.
8.3.2 All water in equipment pipelines and containers should be drained before packing. 8.3.3 Each equipment should be packed in a packing box, which should be equipped with moisture-proof and rain-proof devices to ensure that the equipment is not damaged by nature. 8.3.4 Equipment, accessories and tools must be firmly positioned in the box to prevent loosening and mutual friction during transportation. 8.4 Transportation
Transportation shall be in accordance with the contract.
The packaged equipment should be stored in a well-ventilated room with a relative humidity not exceeding 80% and no corrosive gases. 8
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