Some standard content:
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The test methods for dimensions, mechanical properties, and permeability of this standard refer to the relevant provisions of ISO8637:1989 "Hemodialyzers, Hemofilters, and Hemoconcentrators", the chemical properties refer to the relevant provisions of GB8368-1998 "Disposable Infusion Sets", and the biological properties refer to the relevant provisions of GB/T16886.1—2001 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Appendix A, Appendix B, and Appendix C of this standard are normative appendices. This standard was 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. This standard was drafted by Tianjin Institute of Urology and Tianjin TEDA Biomedical Engineering Co., Ltd. The main drafters of this standard are Gu Hanqing, Lu Laizhu, Song Huifei, Zhu Ximing, and Gao Zengli. 1 Scope
Disposable Hollow Fiber Plasma Separator YY0465—2003
This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, packaging, transportation and storage of disposable hollow fiber plasma separators.
This standard applies to disposable hollow fiber plasma separators (referred to as plasma separators). This product is used in conjunction with plasma separation devices to treat various immune and metabolic disorders and certain poisonings and other critically ill patients for therapeutic plasma exchange. 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, the parties to 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 shall apply to this standard. GB/T191-2000 Pictorial marking for packaging, storage and transportation GB/T2828-1987 Batch-by-batch inspection, counting sampling procedures and sampling tables (applicable to inspection of continuous batches) GB/T2829-2002 Periodic inspection, counting sampling procedures and sampling tables (applicable to inspection of stable production processes) GB/T13074-1991 Blood purification terminology, hemodialysis and hemofiltration GB/T14233.1-1998 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods GB/T14233.2-1993 Medical infusion, blood transfusion, injection Instrument test methods Part II: Biological test methods GB/T16886.1-2001 Biological evaluation of medical devices Part 1: Evaluation and testing GB18278-2000 Sterilization confirmation and routine control requirements for medical care products Moist heat sterilization GB18279-2000 Ethylene oxide sterilization confirmation and routine control for medical devices GB18280-2000 Sterilization confirmation and routine control requirements for medical care products Radiation sterilization ISO8637:1989 Hemodialyzers, hemofilters and hemoconcentrators 3 Terms and definitions
The following terms and definitions apply to this standard. 3.1
Plasma separation
Used to treat various immune and metabolic disorders and certain poisonings and other critically ill patients for therapeutic plasma exchange. 3.2
Filtering rate
The ratio of the solute concentration in the ultrafiltrate to the solute concentration in the blood. 3.3
plasma separation device
plasma separation system
A device composed of blood monitoring, fluid balance, plasma separator and other systems. 3.4
plasma separator
A device made of high molecular polymer membrane for separating macromolecular proteins in blood. 3.5
filtration rate
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The amount of certain substances in the blood that can be filtered out by the plasma separator per unit time. 3.6
transmembrane pressure
transmembrane pressure
the hydrostatic pressure difference of the liquid on both sides of the semipermeable membrane of the plasma separator. 3.7
membrane area
the area of the semipermeable membrane in the plasma separator in contact with the blood, calculated in square meters. 3.8
Blood compartment volumeThe volume of blood that fills the plasma separator when the transmembrane pressure is set. 3.9
Blood flow rate
Blood flow rate
The amount of blood that flows through the plasma separator per unit time, expressed in mL/min. 3.10
Imitation blood
Liquid that artificially prepares the toxic substances contained in blood. 3.11
Clearing fluid
Liquid after the device to be tested is immersed in water for injection. 4 Classification and naming
4.1 Type
The type of plasma separator is hollow fiber type. 4. 2 Basic parameters of plasma separator
4.2.1 Effective membrane area of plasma separator
The effective membrane area of plasma separator shall not be less than 90% of the nominal membrane area. 4.2.2 Blood flow rate of plasma separator
The blood flow rate of plasma separator shall be greater than 200 mL/min. 4.2.3 Filtrate flow rate of plasma separator
The filtrate flow rate of plasma separator shall be greater than 500 mL/min. 4.2.4 Blood chamber capacity of plasma separator
The blood chamber capacity of plasma separator shall not exceed 60 mL. 4.3 Basic dimensions of plasma separator
4.3.1 Inlet and outlet dimensions of plasma separator blood chamber The outlet dimensions of plasma separator blood chamber shall comply with the provisions in Figure 1. 2
1. 2 ± 0, 1
Figure 1 Inlet and outlet dimensions of blood chamber
4.3.2 Inlet and outlet dimensions of plasma separator filtrate chamber The outlet dimensions of plasma separator filtrate chamber shall comply with the provisions in Figure 2. 45
13. 1± 0. 1
Dimensions of inlet and outlet of filtrate chamber
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Unit: mm
Unit: mm
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4.4 Model naming
5 Requirements
5.1 Appearance
Nominal membrane area, m2
Series code
The outer shell of the plasma separator should be transparent, with a smooth surface, and no impurities visible to the naked eye should be present in the liquid channel. 5.2 Dimensions
The effective membrane area of the plasma separator should comply with the provisions of 4.2.1. 5.3 Blood chamber capacity
The blood chamber capacity should comply with the provisions of 4.2.4.
5.4 Particles
The inner cavity of the plasma separator should be clean. The number of particles with a size of 15um to 25μm in 100mL of eluent shall not exceed 200, and the number of particles larger than 25μm shall not exceed 100.
5.5 Chemical properties of plasma separator
5.5.1 Reducing substances (easy oxidizing substances)
The difference in volume of potassium permanganate solution [c(KMnO.)=0.002mol/L] consumed by the test solution and the blank solution shall not exceed 2.0mL. 5.5.2 Metal ions
5.5.2.1 When measured by atomic absorption spectrophotometer (AAS) or equivalent methods, the total content of barium, chromium, copper, lead and tin in the test solution shall not exceed 1μg/ml. The content of shall not exceed 0.1μg/mL. 5.5.2.2 Colorimetric analysis method: The color of the test solution should not exceed the mass concentration of p(Pb2+) 1μg/mL standard control solution. 5.5.3 pH
The difference in pH between the test solution and the blank solution should not exceed 1.5.5.4 Evaporation residue
The total amount of evaporation residue should not exceed 2 mg. 5.5.5 Ultraviolet absorbance
The absorbance of the test solution should not exceed 0.1.
5.5.6 Ethylene oxide residue
The plasma separator is sterilized with ethylene oxide, and the ethylene oxide residue should not exceed 15μg/g. 5.6 Biological performance of plasma separator
5.6.1 Biological evaluation
Plasma separators should be biologically evaluated in accordance with the requirements of GB/T16886.1-2001. 5.6.2 Sterility
The plasma separator shall be sterile.
5.6.3 Pyrogen-free
The plasma separator shall be pyrogen-free.
5.7 Sealing performance of plasma separator
5.7.1 Pressure resistance of plasma separator blood chamber The plasma separator blood chamber shall be able to withstand a test pressure of 100 kPa. 5.7.2 The pressure of the filtration chamber of the plasma separator should be 100 kPa positive pressure and 93.3 kPa negative pressure lower than the atmospheric pressure. 4
5.8 Permeability of plasma separator
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When the transmembrane pressure is 9.3 kPa and the blood flow rate is 150 mL/min, the permeability of the plasma separator with a membrane area of 0.5 m2 should meet the following requirements:
5.8. 1 Plasma filtration rate
The plasma filtration rate should be greater than 40 mL/min. 5.8.2 Total protein screening coefficient
The total protein screening coefficient is ≥0.8.
5. 9 Temperature resistance of plasma separator
The plasma separator should not be deformed or broken within the temperature range of 0℃～50℃. 6 Test method
6.1 Appearance
Visual inspection shall comply with the provisions of 5.1.
6.2 Dimensions
The effective membrane area of the plasma separator is calculated according to formula (1): S= πDL · n× 10-6
Wherein:
S--effective membrane area, in square meters (m); D-hollow fiber inner diameter, in millimeters (mm); L-hollow fiber effective length, in millimeters (mm); n-number of hollow fibers.
6.3 Blood chamber volume test
The blood side and the filtrate side are filled with degassed filling liquid without bubbles, and left for 60 minutes. After the filtrate side is in a sealed state, pressurized air (about 50kPa) is used to drain the water on the blood side for measurement (the amount of filtrate side penetrating into the blood side needs to be subtracted). It shall comply with the provisions of 5.3.
6.4 Microparticles
Perform according to Appendix A and shall comply with the provisions of 5.4. 6.5 Chemical property test methods
6.5.1 Test solution preparation: Take a sterilized product and connect it to a glass flask to form a circulation system, seal the filtrate outlet with a stopper, add 500mL of normal saline according to the nominal fiber area of 1m and keep it at 37℃±1℃, and use a dynamic pump to act on a silicone rubber tube as short as possible to circulate water at a flow rate of 1L/h for 2h. Take 50mL of circulating liquid and dilute it to 1000mL for standby use. 6.5.2 Reducing substances (easy oxidation) test is carried out according to the provisions of 5.2.2 Method 2 in GB/T14233.1-1998 and shall comply with the requirements of 5.5.1. 6.5.3 Metal ion test
6.5.3.1 Atomic absorption spectrophotometry is the arbitration method. The absorbance of the test solution should not be greater than 0.1 and should meet the requirements of 5.5.2.1. 6.5.3.2 Colorimetry: Conduct according to the provisions of 5.5.1 Method 1 in GB/T14233.1-1998 and meet the requirements of 5.5.2.2. 6.5.3 pH
Conduct according to the provisions of 5.4.1 Method- in GB/T14233.1-1998 and meet the requirements of 5.5.3. 6.5.4 Evaporation residue
Conduct according to the provisions of GB/T14233.1-1998 and meet the requirements of 5.5.4. 6.5.5 Ultraviolet absorbance
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Perform the test in the wavelength range of 250nm to 320nm as specified in GB/T14233.1—1998 and shall meet the requirements of 5.5.5. 6.5.6 Ethylene oxide residue
Perform the test in the third part of GB/T14233.1--1998 and shall meet the requirements of 5.5.6. 6.6 Biological performance test method
6.6.1 Biological evaluation
When registering products, the biological performance of the enterprise shall be evaluated in accordance with the provisions of GB/T16886.1-2001. If tests are required, the following shall be conducted:
6.6.1.1 Cytotoxicity shall be conducted in accordance with the provisions of Chapter 7 of GB/T14233.2—1993 and shall be ≤ Grade 1. 6.6.1.2 Intradermal irritation: According to the provisions of Chapter 8 of GB/T14233.2-1993, there should be no irritation. 6.6.1.3 Sensitization test: According to the provisions of Chapter 9 of GB/T14233.2-1993, there should be no irritation. 6.6.1.4 Acute toxicity test: According to the provisions of Chapter 5 of GB/T14233.2-1993, there should be no acute systemic toxicity. 6.6.1.5 Blood compatibility: Hemolysis test: According to the provisions of Chapter 6 of GB/T14233.2-1993, hemolysis rate ≤5%. 6.6.2 Sterility test
The plasma separator is sterilized according to the sterilization process confirmed by GB/T18278-2000 or GB/T18279-2000 or GB/T18280-2000. The sterilization process of each production batch shall be monitored thereafter. 6.6.3 Pyrogen-free test
The plasma separator shall be confirmed to be pyrogen-free before sale. The manufacturer shall then conduct pyrogen tests regularly to ensure that the device is pyrogen-free.
6.7 Sealing performance test
Perform according to the mechanical performance test method in 5.3 of ISO8637:1989 and shall comply with the provisions of 5.7. 6.8 Permeability test
6.8.1 Plasma filtration rate test
Perform according to the method in Appendix B and shall comply with the provisions of 5.8.1. 6.8.2 Total protein screening coefficient test
Perform according to the method in Appendix C and shall comply with the provisions of 5.8.2. 6.9 Temperature resistance test
Put the plasma separator in a 0℃ refrigerator for 3 minutes, then put it in a 50℃ constant temperature box for 3 hours, take it out and restore it to room temperature for observation and pressure test, which shall comply with the provisions of 5.9.
7 Inspection rules
7.1 Factory inspection
7.1.1 Factory inspection is batch inspection.
7.1.2 The monthly output is the inspection batch. 7.1.3 Batch inspection shall comply with the relevant provisions of GB/T2828. 7.1.4 The inspection adopts a one-time sampling plan, and its inspection classification, inspection items, qualified quality level (AQI) and inspection level are specified in Table 1.
7.2 Periodic inspection
7.2.1 Periodic inspection shall be carried out in the following cases: a) When the product is registered;
When there are major changes in process formula or materials that may affect product quality; c)
No less than once a year during normal production; d)
When resuming production after suspension for more than half a year;
When the national quality supervision department makes a request. e) [
Inspection classification
Test group
Inspection items
Inspection level
Table 1 Sampling plan for factory inspection
All qualified
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A single sampling plan is adopted for periodic inspection. The inspection classification, unqualified quality level (RQL) and discrimination level are as specified in Table 2. Table 2 Sampling plan for periodic inspection
Inspection classification
Inspection items
Discrimination level
Inspection cycle
30(A,=0 R.=1)
Once a year
40(A.-0 R=1)
Once every six months
Once every six months
7.2.3 Periodic inspection shall be carried out after each batch is inspected and qualified. The treatment of unqualified periodic inspection shall be carried out in accordance with GB/T2829. 7.2.4 Re-evaluate the biological performance in accordance with the requirements of 3.7 of GB/T16886.1-2001. 8
Each plasma separator shall have the following markings on a conspicuous position on the outer shell: 8.1
Manufacturer name, address and trademark;
Product name and model;
Production batch number and date;
Sterilization method and validity period;
Effective area;
Maximum operating pressure;
Single use;
Product registration number.
8.2The following markings shall be on the certificate:
Manufacturer name;
Product name and model;
Inspector code;
Inspection date.
8.3 The following marks should be on the outer packaging box:
Manufacturer name and address;
b) Product name and model;
Quantity;
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Gross weight:
Volume (length × width × height),
Production batch number and sterilization date,
Product certificate and validity period;
Product registration number;
Product standard number;
Disposable words;
k) "Handle with care", "Do not press heavily", "Afraid of moisture" and other words or marks should comply with the provisions of GB/T191. Packaging, transportation and storage
9.1 Packaging
9.1.1 Single packaging of plasma separator
Each plasma separator should be packaged in a composite film bag, sealed and then packed in a box. The box should contain the instruction manual and the inspection certificate.
Outer packaging of plasma separator
Outer packaging adopts corrugated packaging box.
9.2 Transportation
The transportation method shall be in accordance with the provisions of the order contract. During transportation, heavy pressure, collision, rain and snow shall be avoided. 9.3 Storage
The packaged plasma separator should be stored in a cool, dry, well-ventilated and clean environment with a relative humidity not exceeding 80%, no corrosive gas. The sterilization validity period of the plasma separator is 2 years under the conditions that meet the storage regulations. 8
A.1 Principle
Appendix A
(Normative Appendix)
Method for Determination of Particle Content in Plasma Separator
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This method evaluates contamination by flushing the surface of the inner cavity liquid channel, collecting particles in the eluate on the channel surface, and counting them. A.2 Test Instruments
The instruments and devices are shown in Figure A.1.
Air filter;
Intake needle;
Sodium chloride injection;
-Filter device;
Three-way switch;
Polyvinyl chloride hose;
Tested plasma separator;
Particle counter;
9-Sampling cup.
Figure A.1 Particle content determination device
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A.2.1 Resistance particle counter: with stirring system, one-time sampling volume of 100mL, can count particles of 15um～25μm and larger than 25μm at the same time. bzxz.net
A.2.2 Filter device: microporous filter membrane with internal diameter of 50mm and pore size of 0.45μm. A.2.3 Flushing liquid: sodium chloride injection.
A.2.4 Polyvinyl chloride hose: hose length 1m, outer diameter 3.5mm~4mm. A.2.5 Three-way conversion switch.
A.3 Steps
A.3.1 The filter device is connected to the infusion bottle containing sodium chloride injection through the bottle stopper piercer. The lower end of the filter device is connected to the three-way conversion switch, and the lower end is connected to the hose to the particle counter sampling cup. A.3.2 Rinse the filter, three-way conversion switch and hose with 100mL of flushing liquid. Note: The flushing liquid for the initial test should be no less than 2L. A.3.3 Under a static pressure head of about 1m, let 200mL of flushing liquid pass through the hose. The outflow liquid flows into the sampling cup of the counter to obtain the background liquid. Determine the number of particles in 100mL of the background liquid.
Note: Environmental pollution should be paid attention to during the test.
A.3.4 Repeat the steps of A.3.3, and the average of the two counts is the particle content in 100mL of the background liquid. A.3.5 Seal the air inlet and connect the liquid inlet end of the plasma separator to the other connector of the three-way conversion switch. A.3.6 Under a static pressure head of 1 m, allow 200 mL of flushing liquid to pass through the plasma separator, and 4 mL of the outflow liquid flows into the counter. Dilute with water for injection to a 100 mL sampling cup to obtain the eluate, and determine the number of particles in 100 mL of the eluate. A.4 Result expression
The difference between the particle readings of the eluate and the background liquid is the particle content in the eluate. 10
B.1 Purpose
Appendix B
(Normative Appendix)
Determination of the permeability of plasma separator
The plasma separation value and protein screening rate of the eluate are determined by determination. B.2 Equipment and instruments
B.2.1 Ball blood pump.
B.2.2 500 mL measuring cylinder.
B.2.3 Negative pressure pump.
B.2.4 1000 mL liquid cylinder.
B.2.5 Blood circuit catheter.
B.3 Reagents
Add 2% potassium oxalate to 500mL of fresh pig blood to prepare fresh anticoagulated pig blood. B.4 Operation steps
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B.4.1 Connect the blood inlet and bleeding port of the blood circuit catheter to the blood inlet and bleeding port of the plasma separator, and insert the arteriovenous tube into the container containing anticoagulated pig blood. B.4.2 Connect the blood circuit catheter and pump tube to the ball pump head of the blood pump. B.4.3 Plug the upper end of the plasma separator outlet with a stopper, connect the lower end to the negative pressure pump, and connect the liquid bottle in the middle. B.4.4 Start the blood pump, the blood flow rate is 150mL/min, the negative pressure pump is started, the transmembrane pressure is 9.3kPa, and it stops working after running for 3min. B.4.5 Clean the filtered liquid into the liquid bottle and measure it with a measuring tube. B.5 The result indicates that the plasma permeability is qualified when the measurement exceeds 120 mL. 114 Start the blood pump, the blood flow rate is 150mL/min, start the negative pressure pump, the transmembrane pressure is 9.3kPa, run for 3min and then stop working. B.4.5 Clean the filtered liquid into the liquid bottle and measure it with a measuring tube. B.5 The result indicates that the plasma osmotic performance is qualified when the measurement exceeds 120 mL. 114 Start the blood pump, the blood flow rate is 150mL/min, start the negative pressure pump, the transmembrane pressure is 9.3kPa, run for 3min and then stop working. B.4.5 Clean the filtered liquid into the liquid bottle and measure it with a measuring tube. B.5 The result indicates that the plasma osmotic performance is qualified when the measurement exceeds 120 mL. 11
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