Some standard content:
GB8368--1998
This standard is equivalent to IS08536-4:1998 "Medical Infusion Equipment Part 4: Disposable Infusion Set Gravity Infusion Type". It is also a revised version of GB8368--93. The main technical differences between this standard and IS08536-4:1998 are as follows: This standard adds technical indicators such as the filtration rate of the air filter, the wall thickness and outer diameter of the hose, the adjustment stroke of the flow regulator, and the residual amount of ethylene oxide; the international standard for the test of pH in the chemical requirements adopts the titration method, while this standard adopts the acidometer method; the determination method of the particulate content and the hose length index of this standard are different from the international standard, and the inspection rules of sub-appendix H are added. The main technical differences between this standard and GB8368.---93 are as follows: In terms of physical requirements, the requirements for particulate contamination, sealing, bottle stopper piercer, air filter, hose size, drip bucket, flow regulator, injection piece, protective cover, external cone joint, etc. have been changed; in terms of chemical requirements, the test method has been changed from reference to equivalent international standards, so the technical indicators have changed greatly accordingly, the test items have cancelled chloride, and added cadmium content determination and ultraviolet absorbance, etc. Some changes have also been made in the packaging mark. This revision of this standard incorporates the relevant contents of YY0002-90 "Disposable Liquid Filter for Infusion Sets" and YY/T0142-94 "Disposable Air Filter for Infusion and Blood Transfusion Sets" into this standard. This standard replaces GB8368--93 from the date of implementation. YY0002-90 and YYT0142-94 will be abolished at the same time. Appendix A, Appendix B, Appendix C, Appendix D, Appendix E, Appendix F, Appendix G and Appendix H of this standard are all appendices of the standard. The appendix of this standard is a suggestive appendix.
This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment. The drafting unit of this standard is the Quality Inspection Center for Medical Polymer Products of the State Drug Administration. The main drafters of this standard are Wu Ping, Wang Yanwei, Qin Dongli, Zhang Qiang and Luo Hongyu. This standard was first issued in 1987.
GB 8368-1998
ISO Foreword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization bodies (ISO member bodies). The work of formulating international standards is usually completed by the technical committees of ISO. If each member body is interested in the standard project established by a technical committee, it has the right to participate in the work of the committee. International organizations (official or unofficial) that maintain contact with ISO may also participate in the relevant work. In the field of electrotechnical standardization, IS(I) maintains a close cooperative relationship with the International Electrotechnical Commission (IEC). The draft international standards formally adopted by the technical committee are submitted to the member groups for voting. The international standards must be approved by at least 75% of the member groups participating in the voting. International standard IS(I)8536.4 was formulated by IS(I)/TC76 International Organization for Standardization Technical Committee on Medical Blood Transfusion, Infusion and Injection Equipment.
The general title of ISO) 8536 is medical infusion devices, which consists of the following parts: Part 1: Glass infusion bottles
Part 2: Infusion bottle stoppers
Part 3: Aluminum caps for infusion bottles
Part 4: - Disposable infusion sets
Gravity infusion type
Part 5: Burette infusion sets
Part 6: Freeze-dried stoppers for infusion bottles
Part 7: Aluminum-plastic combination infusion bottle caps
Appendix A, Appendix B, Appendix C, Appendix D, Appendix E and Appendix F are parts of the standard, Appendix G, Appendix H and Appendix J are for reference only.
1 Scope
National Standard of the People's Republic of China
Infusion sets for single use
GB83681998
eqv 1s0 8536-4:1998
Replaces (1 836893wwW.bzxz.Net
This standard specifies the requirements for single-use, gravity-feed infusion sets to ensure compatibility with infusion containers and intravenous equipment. This standard provides guidance for the performance and quality specifications of materials used in infusion sets. It also gives the marking of infusion set components. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards are subject to revision, and parties using this standard should explore the possibility of using the latest versions of the following standards. G131962~1995 Note Syringes, injection needles and other medical devices 6: 100 cases of cone connectors (cqVIS () 594-1: 1996) (B2828.87 Batch inspection counting sampling procedures and sampling tables (applicable to the inspection of continuous batches) GB/T14233.11998 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods GB/T14233.2.93 Inspection methods for medical infusion, blood transfusion and injection equipment Part 2: Biological test methods G3T14437---93 Product quality counting sampling inspection procedures (applicable to situations with large total quantities) GB 15811 1995
Disposable sterile injection needles (ne4IS0) 7864: 1993) (GB3/T16886.1·1997 Biological evaluation of medical devices Part 1: Guide to test selection (idtIS () 10993-1: 1992) - Disposable intravenous infusion needles
YY(0028-.90
YY/03131998 Packaging, marking, transportation and storage of medical polymer products IS) 594.2: 1991 Syringes, injection needles and other medical devices 6% (Luer) cone connector 3 General requirements|| tt||Part II: Locking cone
3.1 The names of the infusion set components and the separate air inlet device components are shown in Figures 1, 2 and 3. Jiang: [Winter 1, 2 and 3 list the structures of the infusion set and the air inlet device. As long as the same effect can be achieved, other structures can be used. 3.2 The infusion set shown in Figure 2 is suitable for plastic folding infusion containers. 3.3 The infusion set shown in Figure】, or the infusion set shown in Figure 2 with the separate air inlet device shown in Figure 3 is suitable for hard infusion sets. Approved by the State Administration of Quality and Technical Supervision on 199811-26 and implemented on 1999-02-01
GB 8368-- 1998
! ·Bottle stopper piercer protective cover; 2-Bottle stopper piercer 3-Air inlet with air filter and stopper\; 4-Liquid channel; 5-Dropper: 6-Drop bucket·-Medicine filter"", 8.-Hose; 9.Flow regulator; 10-Injection piece 3\; 11-External conical joint: 12-External conical joint protective cover 1) It can be without a stopper.
2) The medicine filter can be in other positions, such as preferably at the patient end. The pore size of the membrane of the medicine filter is generally 15um. 3) The injection piece can be omitted.
Figure 1 Example of air-intake infusion set
GB8368--1998
1--Bottle stopper piercing device protective cover; 2-Bottle stopper piercing device; 3 Liquid channel; 4 Dropper: 5-Dripping funnel; 6-Medicine liquid filter"; 7-Hose; 8-Flow regulator. 9.-Injection piece", 10---External conical joint: 1-External conical joint protective cover Figure 2 Example of non-air-intake infusion set
1--Protective cover; 2-Bottle stopper piercing device or puncture needle 3 Hose: 4 Clamp"·5 Air inlet door with air filter 4) If safety can be guaranteed, other designs can also be used. Figure 3 Example of air inlet device
GB 8368 - 1998
3.4 The infusion set should have a protective cover to keep the inner cavity of the infusion set sterile before use. The bottle stopper piercer or puncture needle of the air-inlet device should also have a protective cover
4 Marking example
4.1 Infusion set
The marking example of the air-inlet infusion set that meets the requirements of this standard is: "Infusion set" plus the standard number and production net IS, plus the letter V for air-inlet infusion sets. For non-air-inlet infusion sets, add the letter NV: Example:|| tt||Infusion set GB8368IS-V
Infusion set GB8368IS-NV
4.2 Gas devices
The marking example of the gas inlet device that meets the requirements of this standard is: "Gas inlet device\ plus this standard number plus the initials AD): Example:
Gas inlet device GB8368-AD
5 Materials
The materials for manufacturing the infusion sets and components given in Chapter 3 shall meet the requirements of Chapter 6. The components of the infusion set that come into contact with the solution shall also meet the requirements specified in Chapters 7 and 8.
Note: The standard for the raw materials of polyvinyl nitride for infusion sets is exempted from GB15593.6 Physical requirements
6.1 Particle contamination
Measured according to Appendix F or other equivalent methods. In 200 ml of eluent, the number of particles of 15μm to 25μm shall not exceed 1/ml. The number of particles larger than 25um shall not exceed 0.5/ml. 6.2 Sealing
When tested according to Appendix A, there should be no gas leakage. 6.3 Connection strength
The connection between the components of the liquid channel of the infusion set, excluding the protective cover, shall be able to withstand a static tensile force of not less than [5V for 15 consecutive seconds.6.4 Bottle cold puncture
6.4.1 The dimensions of the bottle cold puncture shall comply with those shown in Figure 4. Dimensions: mm
Note: Metal punctures are not subject to the dimensions of Figure 4. Instructions for use:
1:6.1 Not equivalent to 1S85361:1998
Figure 4 Dimensions of bottle stopper piercer
GB 8368-1998
6.4.2 Bottle stopper piercer shall be able to pierce the bottle stopper of liquid container that has not been pierced. It shall not cause falling during the piercing process. 6.5 Air intake device
6.5.1 The air intake device shall comply with the requirements of 3.4 and 8.2 of the Food Safety Standards. 6.5.2 The air intake device shall have: an air filter to prevent microorganisms from entering the container into which it is inserted. When tested according to Appendix B, the air filter shall have a filtration rate of not less than 90% for particles larger than 0.5μm in the air. 6.5.3 The air intake device may be integral with the bottle stopper piercer of the infusion set or may be separated from it. 6.5.4 When the air intake device is inserted into a hard container, the air entering the container shall not enter the outflowing liquid. 6.5.5 The air filter should be installed so that all air entering the rigid container passes through it. When tested according to Appendix B, the flow rate of the outflowing liquid relative to the free air inlet container should not decrease by 20%. 6.6 Hose
6.6.1 Tubes made of soft materials should be plasticized evenly and transparent or sufficiently transparent. When bubbles pass through, the interface between water and air can be found with normal or corrected vision.
6.6.2 The length of the hose [including the injection piece (if any) and the outer conical joint] from the end to the drip bucket should not be less than 1250) mm26.6.3: The wall thickness of the hose should not be less than 0.4 mm and the outer diameter should not be less than 3.5 mm. 6.7 Liquid filter
The infusion set should have a liquid filter.
When tested according to Appendix (, the filter removal rate should be not less than 80%. 6.8 Dropper
6.8.1 The dropper should be able to observe the droplets continuously. The liquid should enter the dropper through a dropper inserted into the dropper. The distance from the end of the dropper to the outlet of the dropper should be not less than 40mm, and the distance between the dropper and the liquid filter should be not less than 20mm. The distance between the inner wall of the dropper and the outer wall of the dropper terminal should be not less than 5mm. Under the conditions of 23 (soil 2 (, flow rate of 50 drops/min±10 drops/min, 20 drops or 60 drops of distilled water dripped by the dropper should be 1 ml.±(. 1 ml(lg±0. 1 g)
6.8.2 The dropper should be able to introduce the liquid in the infusion container into the infusion set with the help of its elasticity. Its external volume should be not less than 10cm and the average wall thickness should be not less than 0.7 nim.
6.9 Flow regulator
The flow regulator should be able to adjust the liquid flow from zero to maximum, and its adjustment stroke should be not less than 30mm. Note: The flow regulator should be able to be used continuously in multiple infusions without damaging the hose. The contact between the flow regulator and the hose should not produce harmful reactions during storage.
6.10 Infusion flow rate
Under a static pressure head of 1m, for an infusion set with a dropper of 20 drops/ml, the output of sodium fluoride solution [mass concentration ((NaCl)=9g/I] within 10min should be not less than 1000mL; for an infusion set with a dropper of 60 drops/mL, the output of sodium chloride solution [mass concentration (NacCl)= =9g/LJ should be no less than 1000ml. 6.11 Injection parts
If there are injection parts. When tested according to Appendix ID, the water leakage should not exceed one drop. Note: The injection parts should be located near the external cone joint. 6.12 External cone joint
The end of the soft law should have an external cone joint that complies with GB1962 or ISO594-2. Note: (/T1962.1 The cone head separation force index specified is recommended. Various inspection reports should contain the inspection information and conclusions of this performance to facilitate the improvement of product quality.
Adoption instructions:
21, 3, 5), 6: IS0) 8536-4:1998 does not have this technical index. 31[s0 8536-4:1998 Yes 1500 mm
6.13 Protective cover
GB 8368--1998
The protective cover of the infusion set terminal should keep the bottle stopper piercer, the outer conical connector and the inner surface of the infusion set sterile. The protective cover should not fall off naturally and should be easy to remove. 7 Chemical requirements
7.1 Reducing substances (easy oxidation)
When tested according to Appendix F, the difference in volume of potassium permanganate solution Lc (KMnO,) = 0.002 mol/L] consumed by the test solution and the blank solution should not exceed 2.0 ml.
7.2 Metal ions
When determined by atomic absorption spectrophotometry (AAS) or equivalent methods according to E3.1, the total content of barium, chromium, copper, lead and tin in the test solution should not exceed 1 μg/ml. The content of radiation should not exceed 0.1μg/ml. When tested according to E3.2, the color of the test solution should not exceed that of the standard control solution with a mass concentration of o(Pb) = 1ug/mL.
7.3 pH?
When tested according to Appendix E, the difference in pH between the test solution and the blank solution should not exceed 1.5. 7.4 Evaporation residue
When tested according to Appendix E, the total amount of evaporation residue should not exceed 2mg. 7.5 Ultraviolet absorbance
When tested according to Appendix E, the absorbance of the test solution should not be greater than 0.1.7.6 Ethylene oxide residue"
When tested according to GB/T14233.1, the ethylene oxide residue of each infusion set should not be greater than 0.5 mg.8 Biological requirements
8.1 General
Infusion sets should not release any substances that have side effects on patients. Appropriate tests should be used to evaluate the toxicity of infusion set materials, and the test results should indicate non-toxicity. GB/T16886.1 provides guidance on toxicity tests.8.2 Sterility
The infusion set and/or air inlet device in a single package should undergo an effective sterilization process to make the product sterile. Appendix G provides the sterility test method.
8.3 Pyrogen||tt ||Appropriate tests should be used to evaluate the pyrogenicity of the infusion set and/or the air inlet device, and the results should indicate that the infusion set is pyrogenic. The pyrogenicity test method is given in the appendix.
8.4 Hemolysis
The infusion set should be evaluated for the absence of hemolytic components, and the test results should indicate that the infusion set has no hemolytic reaction. The hemolysis test method is given in GB/T14233.2.
8.5 Acute systemic toxicity
The acute systemic toxicity of the infusion set should be evaluated, and the test results should indicate that the infusion set has no acute systemic toxicity. The acute systemic toxicity test method is given in GB/T14233.2.
Instructions for use:
7:IS03536-4:998 uses the titration method
811S03536-4:1998 is 5 mg
9)IS0）3536-4：.998No such technical index370
9Mark
9.1 Single package
The single package should be marked with at least the following information: GB8368 -1998
a) A written description of the contents, including the words "gravity infusion only"; b) Use the graphic symbol given in YY/T0313 to indicate that the infusion set is sterile:) The infusion set is pyrogen-free;
d) The infusion set is for single use only, or equivalent instructions; Note: A "single use" graphic symbol in accordance with YY/9313 may also be given. e) Instructions for use, including warnings for checking the integrity of the package seal and any detachment of the protective cover; Note: Instructions for use may also be in the form of an insert. 1) Batch number, beginning with "batch":
&) Expiration date and month (must be clearly identifiable): h) Name and address of the manufacturer and/or distributor; i) Instructions that 20 drops or 60 drops of distilled water from a dropper is equivalent to 1ml.±0.1ml. (1g±0.1g); j) If an intravenous needle is used, the specifications should be indicated.
9.2 Secondary packaging
The secondary packaging shall have at least the following information:
a) a written description of the contents, including the words "gravity infusion only";
b) the number of infusion sets:
c) the graphic symbol given in YY/T0313 indicating that the infusion sets are sterile;
d) the batch number shall begin with "batch";
e) the expiration date and month:
f) the name and address of the manufacturer and/or distributor;
m) the recommended storage conditions (if any), 9.3 Outer packaging
The information on the outer packaging shall comply with YY/T0313. 10 Packaging
10.1 Infusion sets and/or air inlet devices shall be packaged individually to keep them sterile during the storage period. After opening the single package, there shall be no signs of opening. 10.2 The packaging and sterilization of infusion sets and/or air inlet devices shall ensure that they are not flattened or folded when ready for use. 10.3 There shall be no visible foreign matter in the single package$71
GB 8368 --- 1998
Appendix A
(Standard Appendix)
Sealing test
Infusion set--end sealed, immersed in 20E30 water, and passed through an air pressure 20kPa higher than atmospheric pressure for 10s. Check for signs of leakage in the infusion set.
Appendix B
(Standard Appendix)
Test method for air filter removal rate and flow reduction rate B1 Removal rate test
B1.1 Test instrument
Dust particle counter: sampling tube length is 1m, sampling frequency is 1 time/min. Rotor flowmeter: range is 80ml./min or 100ml./min. B1.2 Test steps
Under static environmental conditions, connect the dust particle counter to the flowmeter, and measure the number of particles larger than 0.5pm in the air collected within 1min at an air flow rate of 50ml./min. Read five data continuously. Take another air filter and connect it to the air inlet of the flowmeter according to the direction of use. Under the same air flow rate, measure the number of particles larger than 0.5μm in the air flowing through the air filter within 1mi. Read five data continuously. Remove the maximum and minimum values from the five data and take the average of the remaining three values. B1.3 Nesting expression
Formula (B1) gives the filter removal rate. Expressed as a percentage: /×100
Where: n. Number of particles larger than 0.5μm in the air; number of particles larger than 0.5um in the air after passing through the air filter. n
B2 Flow reduction rate test
·(B1)
B2.1 Use a glass infusion bottle to fill it with 23C ± 2C distilled water and cover it with a bottle stopper. Install a needle with an outer diameter of 0.8mm on the outer conical connector of the infusion set. Insert the air inlet device into the bottle through the bottle stopper, and then adjust the flow regulator so that the infusion set is in the closed state and the bottle has a static water head of 1m. Adjust the flow regulator to the maximum and measure the flow of water. Remove the filter from the air inlet device and repeat the above steps. B2.2 For infusion sets with integrated bottle stopper piercer and air inlet device, follow the steps in B2.1, but do not insert the separate air inlet device into this step. 372
Microscope method (arbitration method)
C1.1 Preparation of test solution
GB 8368 -- 1998
Appendix C
(Standard Appendix)
Test for the removal rate of drug filter
Use a suspension of latex particles with a diameter of 20um! ! mm, and 100ml of the test solution contains 1000 particles. C1.2 Install the liquid filter in the test device shown in Figure (1) to make it consistent with the actual use state. Cut the infusion hose about 10cm below the liquid filter. Rinse the liquid filter with 5ml of test solution in the liquid bottle and discard the filtrate. Pass 100ml of test solution through the liquid filter. Under vacuum conditions, let all the effluent pass through a black grid filter membrane with a pore size of 5um to 8μm and a diameter of 47mm. Place the filter membrane with latex particles in an appropriate On a microscope slide or tray, count the latex particles in not less than 50% of the grid area at a magnification of 50 to 100 times, and ignore obvious non-latex particles. The test is carried out twice.
If the required filtration rate of 80% is not achieved, repeat the test. Note: The entire process of this test should be carried out in a clean environment, if possible, under laminar flow conditions. C1.3 Result Expression
Formula (C1) gives the filtration rate of the filter, expressed as a percentage: 11-
j× 100
Wu Zhong: "…The number of particles retained on the filter membrane (passing through the liquid filter); the number of particles in the test solution used.
C2 Particle counter method
C2.1 Test instrument
Resistive particle counter.--The sampling volume is 100ml.C2.2 Test solution
(（1）
The test solution is a suspension of latex particles with a diameter of 20um±1μm, and each 100ml of the test solution (sodium chloride solution with a mass concentration of 9g/1.) contains 3 (000) latex particles of standard material.C2.3 Steps
Take 150n1l. Test Liquid is made to flow through the liquid filter under a static pressure head of 1m, and the filtrate is made to flow into the sample pool of a clean counter, and the particles with a diameter of 20um±1μm in 100ml of filtrate in the sample pool are counted. C2.4 Conclusion
Calculate the filtration rate of the liquid filter according to formula (C1). Instructions for use:
10! [S8536-4:1998 does not specify the particle counter method. 373
GB8368
1 Liquid storage bottle; 2--Delivery tube; 3 Flow regulator; 4--Connector; 5 Puncturer; 6-Liquid filter; 7-Filter membrane Figure C1 Liquid filter efficiency test deviceThe test liquid passes through the liquid filter, and under vacuum conditions, all the outflow liquid passes through a black grid filter membrane with a pore size of 5um to 8μm and a diameter of 47mm. The filter membrane with latex particles is placed on a suitable microscope slide or tray, and the latex particles in not less than 50% of the grid area are counted at a magnification of 50 to 100 times. Obvious non-latex particles are not counted. The test is carried out twice.
If the required filtration rate of 80% is not achieved, repeat the test. Note: The entire process of this test should be carried out in a clean environment, and if possible, it can be carried out under laminar flow conditions. C1.3 Result Expression
Formula (C1) gives the filtration rate of the filter, expressed as a percentage: 11-
j× 100
Wu Zhong: "…The number of particles retained on the filter membrane (passing through the liquid filter); the number of particles in the test solution used.
C2 Particle counter method
C2.1 Test instrument
Resistive particle counter.--The sampling volume is 100ml.C2.2 Test solution
(（1）
The test solution is a suspension of latex particles with a diameter of 20um±1μm, and each 100ml of the test solution (sodium chloride solution with a mass concentration of 9g/1.) contains 3 (000) latex particles of standard material.C2.3 Steps
Take 150n1l. Test Liquid is made to flow through the liquid filter under a static pressure head of 1m, and the filtrate is made to flow into the sample pool of a clean counter, and the particles with a diameter of 20um±1μm in 100ml of filtrate in the sample pool are counted. C2.4 Conclusion
Calculate the filtration rate of the liquid filter according to formula (C1). Instructions for use:
10! [S8536-4:1998 does not specify the particle counter method. 373
GB8368
1 Liquid storage bottle; 2--Delivery tube; 3 Flow regulator; 4--Connector; 5 Puncturer; 6-Liquid filter; 7-Filter membrane Figure C1 Liquid filter efficiency test deviceThe test liquid passes through the liquid filter, and under vacuum conditions, all the outflow liquid passes through a black grid filter membrane with a pore size of 5um to 8μm and a diameter of 47mm. The filter membrane with latex particles is placed on a suitable microscope slide or tray, and the latex particles in not less than 50% of the grid area are counted at a magnification of 50 to 100 times. Obvious non-latex particles are not counted. The test is carried out twice.
If the required filtration rate of 80% is not achieved, repeat the test. Note: The entire process of this test should be carried out in a clean environment, and if possible, it can be carried out under laminar flow conditions. C1.3 Result Expression
Formula (C1) gives the filtration rate of the filter, expressed as a percentage: 11-
j× 100
Wu Zhong: "…The number of particles retained on the filter membrane (passing through the liquid filter); the number of particles in the test solution used.
C2 Particle counter method
C2.1 Test instrument
Resistive particle counter.--The sampling volume is 100ml.C2.2 Test solution
(（1）
The test solution is a suspension of latex particles with a diameter of 20um±1μm, and each 100ml of the test solution (sodium chloride solution with a mass concentration of 9g/1.) contains 3 (000) latex particles of standard material.C2.3 Steps
Take 150n1l. Test Liquid is made to flow through the liquid filter under a static pressure head of 1m, and the filtrate is made to flow into the sample pool of a clean counter, and the particles with a diameter of 20um±1μm in 100ml of filtrate in the sample pool are counted. C2.4 Conclusion
Calculate the filtration rate of the liquid filter according to formula (C1). Instructions for use:
10! [S8536-4:1998 does not specify the particle counter method. 373
GB8368
1 Liquid storage bottle; 2--Delivery tube; 3 Flow regulator; 4--Connector; 5 Puncturer; 6-Liquid filter; 7-Filter membrane Figure C1 Liquid filter efficiency test device
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