Some standard content:
GB18671--2002
Article 6.9 of this standard is recommended, and the rest are mandatory.
From the date of implementation of this standard, YY0028-1990 "Disposable Intravenous Infusion Needles" shall be abolished. Appendices A to E of this standard are all standard appendices. Appendices F to H of this standard are all suggestive appendices. 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 Infusion Equipment. This standard was drafted by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center and Zhejiang Kangdelai Medical Equipment Plastic Co., Ltd.
The main drafters of this standard are: Wang Yanwei, Wu Ping, Zhang Honghui, Zhang Qiang, and Li Kefang. 442
GB18671--2002
Disposable intravenous infusion needles are mainly supplied in two ways. One is to supply to hospitals with disposable infusion sets, and the other is to supply to hospitals as independent commodities. In my country, the first supply method accounts for the majority. For intravenous infusion needles supplied with disposable infusion sets, the requirements for factory inspection, packaging, and marking specified in this standard are not applicable. In order to avoid inhibiting innovation, this standard does not limit the combination of needle diameter and length. However, considering clinical needs, the standard requires that the needle length should be marked at the same time as the outer diameter of the needle; the sharpness of the needle tip of the infusion needle has very important clinical significance. Appendix G of this standard provides two evaluation methods, qualitative and quantitative. Qualitative methods are particularly suitable for process detection and horizontal comparison when clinical units select infusion needles due to their simplicity, intuitiveness, and practicality. They are of great significance to promoting the quality of needle tips in my country; quantitative evaluation methods provide methods for further evaluating needle tip sharpness, but this method currently needs to be further established internationally. my country will consider formulating a quantitative evaluation standard for needle tip sharpness. Considering the coordination with future standards, this standard is given in a prompt appendix. The sharpness index of intravenous infusion needles is not given in the standard, and it will be added to the standard when conditions are ripe in the future.
The soft double-wing handle infusion needle shown in Figure 1 has the advantage of being firmly fixed during infusion and is safer than the single-wing handle infusion needle. However, nurses who are used to the hard single-wing handle may not be able to adapt to it at first. It is recommended that the needle wings of this double-wing needle should not be designed to be too soft. The correct method of use is recommended to nurses.
A month ago, the 6% internal cone joints of domestic intravenous infusion needles were mostly made of soft polyvinyl chloride. Due to the softness of this material, the performance requirements of the cone joint are difficult to meet the requirements of GB/T1962. Considering that there is little urgency for improving the requirements in clinical practice, and in order to maintain coordination with relevant standards, the standard no longer relaxes the requirements for its performance indicators (especially separation force), and lists this clause (6.9) as a recommended clause. Various inspection reports should contain the inspection information and conclusions of this performance to promote the improvement of product quality. 443
1 Scope
National Standard of the People's Republic of China
Intravenous needles for single use
Intravenous needles for single useGB18671.- 2002
This standard specifies the requirements for single-use intravenous needles (hereinafter referred to as "infusion needles") with a nominal outer diameter of 0.4mm to 1.2mm to ensure compatibility with corresponding infusion equipment. This standard provides guidance for the performance and quality specifications of materials used for infusion needles. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. At the time of publication of this standard, the versions shown are valid. All standards are subject to revision, and parties using this standard should explore the possibility of using the latest version of the following standards. GB/T1962.1--2001 Syringes, injection needles and other medical devices 6% (Luer) cone connector Part 1: General requirements GB/T 1962.2--2001
Syringes, needles and other medical devices 6% (Luer) cone connector Part 2: Locking connector GI3/T2828-1987 Batch inspection counting sampling procedure and sampling table (applicable to the inspection of continuous batches) GB8368-1998-Disposable infusion sets GB/T 14233.1.1998
Medical infusion, blood transfusion and injection equipment inspection methods Part 1: Chemical analysis methods G3/T14233.2-1993 Medical infusion, blood transfusion and injection equipment inspection methods Part 2: Biological test methods GB/14437-1997 Product quality counting-~sub-surveillance sampling inspection procedures (applicable to situations with large total quantities) GB/T 16886. 1- -2001
Biological evaluation of medical devices Part 1: Evaluation and testing GB 18457-- 2001
Manufacturing of stainless steel needle tubes for medical devices
YY/T 0296—1997
“Identification color code for disposable injection needles
YY/T0313—1998 Packaging, marking, transportation and storage of medical polymer products 3 Structural type
The structural type of infusion needle is shown in Figure 1.
Unit: mm
Needle specifications
-Protective cover; 2--Needle tube; 3--Needle handle: 4--Hose; 5·Needle seat [】Can be equipped with protective devices.
Figure 1
Example of a typical infusion needle
Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on March 5, 200244
Implementation on July 1, 2002
GB18671--2002
Method: Figure 1 shows the typical structure of an infusion needle. Other structures may also be used as long as the same effect can be achieved. 4 Marking example
The marking of a disposable intravenous infusion needle with a needle tube diameter of 0.7mm and a needle tube length (1 in Figure 1) of 25mm required by this standard is:
Infusion needle GB18671·20020.7X25
5 Materials
The materials used to make infusion needles shall meet the requirements of Chapter 6. The components of infusion needles that come into contact with the drug solution shall also meet the requirements specified in Chapters 7 and 8.
Note: The standard for raw materials of polyvinyl chloride for infusion needles can be found in GB15593.6 Physical requirements
6.1 Color code
The color of the handle and/or protective sleeve of the infusion needle shall be used as the color code for the nominal outer diameter of the needle tube. Its color shall meet the requirements of YY/T0296.
6.2 Particle contamination
When tested according to Appendix A, the number of particles of 15μm to 25μm in the infusion needle shall not exceed 1.00/ml; the number of particles larger than 25um shall not exceed 0.50/ml.
6.3 Connection firmness
6.3.1 The connection between the handle and the needle tube of the infusion needle shall not be disconnected or loosened when a static axial tension of 20N is applied for 10s. 6.3.2 Apply a static axial tension of 15N between the infusion needle hose and the needle handle and between the hose and the needle seat for 105 seconds. The joints must not loosen or separate.
6.4 Tightness
The inner cavity of the infusion needle should have good sealing. There should be no leakage when tested according to Appendix B. 6.5 Flow
Measure the output flow of water from the infusion needle at a pressure of 20kPa using the flow test device given in Appendix C. It should not be lower than that specified in Table 1. Table 1 Infusion needle flow rate
Flow base/(ml./min)
(27G)
(23G)
Note: The needle pass specified in Table 3 of (B15811-2001) can be used to quickly evaluate the smoothness of the needle tube. 6.6 Aluminum tube
6.6.1 General
The needle tube shall be made of stainless steel needle tube that meets the requirements of GB18457. 0.7
(22G)
(2IG)
1(19()
6.6.2 Needle tube lengthbZxz.net
When the nominal value of the needle tube length is less than or equal to 15mm, the length shall be ±1.0mm of the nominal value; When the nominal value is greater than 15mm, the length should be \2.mm of the nominal value.
6.7 Needle tip
When inspected under 2.5 times magnification, the needle tip should be sharp, without defects such as burrs, burrs and hooks. The needle tip should have good puncture performance. Note
"The first bevel angle of the needle tip is usually (17±2). However, the "long" edge angle can also be used, such as (11±2)°. Appendix F gives the size and naming of the needle tip geometry. When describing the needle tip configuration, it is not necessary to use all the dimensions shown in the figure. 2 Appendix G recommends two needle tip puncture performance test methods. 6.8 Lubricant
If the needle is coated with lubricant, there should be no visible accumulation of lubricant on the outer surface of the needle when observed with normal or corrected vision. Note: A suitable lubricant is undiluted polydimethylsiloxane that complies with the "Chinese Pharmacopoeia". The amount of lubricant per square centimeter of the needle surface should not exceed 0.25 mg.
6.9 Needle seat
The inner conical joint of the needle seat of the infusion needle should comply with GB/T1962.1. If the needle seat is a locking joint, it should comply with GB/T1962.2.6.10 Needle handle
The needle handle should be complete and clearly marked. The needle handle should be in the same direction as the needle tip bevel (as shown in Figure 1), and its inclination should not exceed 30°. 6.11 Hose
The hose of the infusion needle should be soft, transparent, smooth, and free of obvious mechanical impurities, foreign matter, or kinks. Its transparency should ensure that bubbles and blood return can be observed.
6.12 Protective cover
The infusion needle tube should have a protective cover, which should not fall off naturally and should be easy to remove. 7 Chemical requirements
7.1 Reducing substances
When tested according to Appendix D, the difference in volume of potassium permanganate solution [c(KMnO,)=0.002mol/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 Appendix DD.3.1, the total content of lock, chromium, copper, lead and cadmium in the test solution should not exceed 1ug/mL. The content of cadmium should not exceed 0.1μg/mL. When tested according to Appendix DD.3.2, the color of the test solution should not exceed that of the standard control solution with a mass concentration of p(Pb2+)-1ug/mL.
7.3 pH
When tested according to Appendix D, 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 D, the total amount of evaporation residue should not exceed 2 mg. 7.5 UV absorbance
When tested according to Appendix D, 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 in each infusion needle should not be greater than 0.1 mg. 8 Biological requirements
8.1 General
Infusion needles should not release any substances that may cause side effects to patients. Appropriate tests should be used to evaluate the toxicity of infusion needle materials, and the test results should indicate non-toxicity. GB/T16886.1 provides guidance on toxicity tests. 8.2 Sterility
The infusion needles in a single package should be sterilized through a confirmed sterilization process. Note
1 For suitable sterilization methods, see Appendix H.
GB 18671-2002
2 (GB/T14233.2 specifies the sterility test method. However, this method is not suitable for factory inspection. 8.3 Bacterial endotoxins
When testing according to (GB/T14233.2, no more than 5 mL of the extraction medium is injected into each infusion needle, and the bacterial endotoxin content should be less than 0.5EU/ ml..
8.4 Hemolysis
The infusion needle should be evaluated for the absence of hemolytic components, and the test results should show that the infusion needle has no hemolytic reaction. GB3/T14233.2 gives the hemolysis test method.
9 Marking
9.1 Single package
The single package should have at least the following information:
a) Product name;
b) Specifications and length of the infusion needle tube;
c) Use the graphic symbol given in YY/T0313 to indicate that the infusion needle is sterile; d) The infusion needle is pyrogen-free;
e) For single use only, or equivalent instructions; Note: The "single use" graphic symbol in YY/T0313 can be given separately. f) Instructions for use, including a warning for checking the integrity of the package seal and any detachment of the protective cover; g) Batch number, beginning with the word "batch";
h) Expiration date and month (must be clearly identifiable); i) Name and address of the manufacturer;
9.2 Intermediate packaging
The intermediate packaging shall contain at least the following information:
a) Product name;
b) Specifications and length of the infusion needle;
c) Number of infusion needles;
d) Indication of sterility of the infusion needle using the graphic symbol given in YY/T0313; e) Batch number, beginning with the word "batch";
() Expiration date and month;
g) Name and address of the manufacturer;
h) Recommended storage conditions (if any). 9.3 Outer packaging
The information on the outer packaging shall comply with the requirements of YY/T0313. 10 Packaging
10.1 Infusion needles should be packaged individually or with infusion sets to keep them sterile during their validity period. After opening the single package, there should be traces of opening.
10.2 The packaging and sterilization of infusion needles should ensure that they are not flat or folded before use. 10.3 There should be no foreign matter visible to the naked eye in the single package of infusion needles. 447
A1 Method
GB 18671 - --2002
Appendix A
(Appendix to the standard)
Particulate contamination test
The method specified in GB8368 shall be followed, but the preparation of eluent shall be carried out in accordance with the provisions of A2. Note: It can also be tested with a light obscuration counter that meets the requirements. A2 Preparation of eluent
Take 5 infusion needles to prepare eluent. For infusion needles with a needle tube outer diameter of less than or equal to 0.8mm, remove the infusion needle from the hose, and under a static pressure head of 1m, let the flushing liquid flow through 5 infusion needle hoses, 40mL each, and collect the eluate in the sampling cup of the counter, a total of 200ml..
Appendix B
(Standard Appendix)
Sealing Test
Seal the needle tube of the infusion needle, immerse it in 20℃～30C water, and let the air pressure 20kPa higher than the atmospheric pressure pass through the cone hole of the needle seat for 10s. Check for signs of air leakage in the infusion needle.
Appendix C
(Appendix to the standard)
Flow test device
Figure (1 shows an example of a flow test device. Other equivalent methods may also be used. 2
1 Inflatable ball with a one-way valve; 2-sphygmomanometer, 3 Liquid pipeline; 4-switch; 5 Test infusion needle; 6 Weighing container Figure C1 Flow test device
D1 Preparation of test solution
GB18671 -—2002
Appendix D
(Appendix of the standard)
Chemical analysis of dissolved substances
Take 25 infusion needles, remove the protective cover and cut the hose part into 1cm long sections, put them together with the needle tube into a glass container, add 250ml of water and keep it at 37℃±1℃ for 2h, collect all the liquid and cool it to room temperature as the test solution. Take the same volume of water and put it in a glass container, without adding samples, prepare the control solution in the same way. 2 Reducing substances (easy oxidation) test
Perform according to the provisions of 5.2.2 Method 2 in GB/T14233.1—1998. D3 Metal ion test
D3.1 Atomic absorption: Perform according to the provisions of 5.9.1 in GB/T14233.11998. D3.2 Colorimetry: Perform according to the provisions of 5.6.1 Method- in GB/T14233.1—1998. D4 pH test
Perform according to the provisions of 5.4.1 method in GB/T14233.11998. D5 Evaporation residue test
Perform according to the provisions in GB/T14233.1
D6 Ultraviolet absorbance test
Perform according to the provisions in GB/T14233.1 within the wavelength range of 250nm320nm. Appendix E
(Appendix to the standard)
Inspection rules
E1 Type test
E1.1 Type test should be carried out in the following cases: a) When new products are put into production, the source of materials or the formula is changed; bh) When there are major changes in the structure, key parts and components, and the process; () When continuous production exceeds half a year;
d) When production is resumed after suspension of production;
() When required by the contract or the supervisory and management department. E1.2 Type inspection is a full performance inspection. In the case of E1.1a), a comprehensive physical evaluation of the selected materials shall also be carried out. E1.3 During the type test, 5 needles are randomly sampled for each requirement in Chapter 6, Article 9.1 and Chapter 10. E1.4 If all inspection items are qualified, the type inspection is passed. If the type inspection fails, mass production shall not be carried out. Note: The requirements for 6.9 needle seats in the type inspection should be issued as a single inspection report according to the standard provisions, but they may not be involved in the judgment of the overall results. See also 449 of this standard (incubation and introduction), E2 Factory inspection (recommended) GB 18671 ---2002 Note: F2 provisions do not apply to the situation where infusion needles and infusion sets are supplied in sets. E2.1. Factory inspection is carried out batch by batch according to GB/T2828. Only qualified products can be shipped out. E2.2 The physical requirements (counting items), unqualified classification, inspection level (II.) and qualified quality level (AQL) of factory inspection are in accordance with Table E1.
Inspection items
Particle contamination
Connection firmness
Sealing
Needle tube length
Lubricant
Protective cover
E2.3 The production batch should also be inspected for reducing substances, pH, ultraviolet absorbance and bacterial endotoxins. AQL
E2.4--The products of the sterilization process constitute the sterilization batch. Each sterilization batch should be monitored by effective methods. Products sterilized with ethylene oxide shall be allowed to leave the factory only after the residual amount of ethylene oxide after sterilization is controlled below the specified value. E3 National supervision and random inspection shall be carried out in accordance with the provisions of (B/T14437. The needle rotates at a mid-angle. GB 18671-2002 Appendix F (Suggested Appendix) The marking view of the size and naming of the needle tip geometry shows the difference when the first bevel crosses the needle tip. d-needle tube outer diameter; d-needle tube inner diameter A needle tip length: B-first bevel nominal length; B right bevel length; B2 left bevel length second bevel nominal length:, ·right second bevel length; 2 left bevel length ; α first bevel angle: second bevel angle:
degrees; β needle tip angle: 0, right second bevel rotation angle; 0 left second. Bevel rotation angle; combined second bevel angle Figure F1 Needle tip geometry and naming designation
Appendix G
(suggestive appendix)
Needle tip puncture performance test method
G1 Method 1: Qualitative test method
Cover the rubber medical glove (in accordance with GB7543) with a diaphragm On the mouth of a cup with a diameter of about 100 mm, tighten it appropriately and fix it with a rubber band, and hold the infusion needle vertically to puncture the membrane. During the puncture process, if the membrane is slightly concave, the hand feels soft, and the sound is small, it means that the needle tip is sharp. On the contrary, it means that the needle tip is not sharp.
Note: This method can qualitatively evaluate the puncture performance of the needle by hand. It is suitable for the purchaser to make a horizontal comparison and quality control in the production process. G2 Method 2: Quantitative test method
G2.1 Test instrument for puncture force evaluation
Figure (1 is a schematic diagram of the typical instrument composition for measuring and recording puncture force. Other devices with the same performance and accuracy can also be used. The instrument should provide:
a) Speed V = (50) ~ 250) mm/min, average drive accuracy ≤ set drive speed ± 5%; b) (0 ~ 50) N sensor, average accuracy is full scale ± 5%; c) The diameter of the puncture area after the polymer film is clamped is equal to 10 mm. .131
GB 18671—2002
·Transmission device with force sensor; b)—Test needle; c) Polymer film; d)…—Polymer film holding device; a
Signal amplifier; f)—Data processing device; g)—Plotter; h)—Cartridge disk storage device e
Figure G1 General composition of polymer film puncture force tester G2.2 Polymer film material
The polymer film suitable for puncture test is a polyurethane film with elasticity, thickness of 0.35mm±0.05mm, and Shore (A) hardness of 85±10.
G2.3 Puncture force evaluation test steps
G2.3.1 The polymer film is placed at 22°C±2°C for at least 24h and tested at the same temperature. G2.3.2 Clamp a portion of a continuous length of polymer film c vertically in a clamping device d, avoiding tension on the polymer film. If the polymer film has a finished surface, this surface should face the needle tip. G2.3.3 The test needle is mounted on a fixture with its axis perpendicular to the surface of the polymer film and the needle tip pointing to the center of the circular area to be punctured. G2.3.4 The moving speed is set to 100 mm/min. G2.3.5 Start the test instrument.
G2.3.6 Puncture the polymer film and record the force versus displacement curve from time to time. G2.3.7 Determine the corresponding peak forces F, F, F2, F4. G2.3.8 Each time a polymer film is punctured, an area that has not been used and punctured before should be selected. G2.4 Record the peak forces in the coordinate graph
When the needle punctures, the force values can be identified by observing several typical peaks passing through the polymer film. F, peak force when the needle tip pierces the polymer film
F, peak force when the second plane of the needle cuts through the polymer film, F, peak force when the second plane of the needle expands the polymer film, F, peak friction force when the needle passes through the polymer film along the length of the needle tube, G3, result representation
The measured force-displacement coordinate diagram should be evaluated by comparing it with the graph of the same type of needle (whose quality and performance are known). G4, G5 and G6 give typical coordinate diagrams, and also give the way to report the test results. 152
G4, typical characteristic coordinate diagram of needle piercing membrane material
Photograph obtained by high-speed photography technology. +-mm
GB18671--2002
1 Initial movement of needle
2 Needle meshes with membrane material, force value increases to F3 Needle tip pierces membrane material
4 The second plane edge expands the membrane material, force value increases to F5 The second plane edge partially penetrates the membrane material
6 The second half-surface edge completely penetrates the membrane material
7 The ...-plane edge expands the membrane material, force value increases to F8 Needle tube friction movement, force value decreases to 13 Test steps for evaluating puncture force
G2.3.1 Place the polymer film at 22°C ± 2°C for at least 24 h and conduct the test at the same temperature. G2.3.2 Clamp a portion of a continuous length of polymer film c vertically in a clamping device d, avoiding tension on the polymer film. If the polymer film has a finished surface, this surface should face the needle tip. G2.3.3 The test needle is mounted on a fixture with its axis perpendicular to the surface of the polymer film and the needle tip pointing to the center of the circular area for puncture. G2.3.4 Set the moving speed to 100 mm/min. G2.3.5 Start the test instrument.
G2.3.6 Puncture the polymer film and record the force versus displacement curve from time to time. G2.3.7 Determine the corresponding peak forces F,, F,, F2, and F4. G2.3.8 Each time a polymer film is punctured, an area that has not been used and punctured before should be selected. G2.4 Record the peak force in the coordinate graph
When the needle pierces the polymer film, the force values can be identified by observing several typical peaks passing through the polymer film. F, peak force when the needle tip pierces the polymer film
F, peak force when the second plane of the needle cuts through the polymer film, F, peak force when the second plane of the needle expands the polymer film, F, peak friction force when the needle passes through the polymer film along the length of the needle tube. G3 Result representation
The measured force-displacement coordinate graph should be evaluated by comparing it with the graph of the same type of needle (whose quality and performance are known). G4, G5 and G6 give typical coordinate graphs, and also give the way to report the test results. 152
G4 Typical characteristic coordinate graph of needle piercing membrane material
Photograph obtained by high-speed photography technology. +-mm
GB18671--2002
1 Initial movement of needle
2 Needle meshes with membrane material, force value increases to F3 Needle tip pierces membrane material
4 The second plane edge expands the membrane material, force value increases to F5 The second plane edge partially penetrates the membrane material
6 The second half-surface edge completely penetrates the membrane material
7 The ...-plane edge expands the membrane material, force value increases to F8 Needle tube friction movement, force value decreases to 13 Test steps for evaluating puncture force
G2.3.1 Place the polymer film at 22°C ± 2°C for at least 24 h and conduct the test at the same temperature. G2.3.2 Clamp a portion of a continuous length of polymer film c vertically in a clamping device d, avoiding tension on the polymer film. If the polymer film has a finished surface, this surface should face the needle tip. G2.3.3 The test needle is mounted on a fixture with its axis perpendicular to the surface of the polymer film and the needle tip pointing to the center of the circular area for puncture. G2.3.4 Set the moving speed to 100 mm/min. G2.3.5 Start the test instrument.
G2.3.6 Puncture the polymer film and record the force versus displacement curve from time to time. G2.3.7 Determine the corresponding peak forces F,, F,, F2, and F4. G2.3.8 Each time a polymer film is punctured, an area that has not been used and punctured before should be selected. G2.4 Record the peak force in the coordinate graph
When the needle pierces the polymer film, the force values can be identified by observing several typical peaks passing through the polymer film. F, peak force when the needle tip pierces the polymer film
F, peak force when the second plane of the needle cuts through the polymer film, F, peak force when the second plane of the needle expands the polymer film, F, peak friction force when the needle passes through the polymer film along the length of the needle tube. G3 Result representation
The measured force-displacement coordinate graph should be evaluated by comparing it with the graph of the same type of needle (whose quality and performance are known). G4, G5 and G6 give typical coordinate graphs, and also give the way to report the test results. 152
G4 Typical characteristic coordinate graph of needle piercing membrane material
Photograph obtained by high-speed photography technology. +-mm
GB18671--2002
1 Initial movement of needle
2 Needle meshes with membrane material, force value increases to F3 Needle tip pierces membrane material
4 The second plane edge expands the membrane material, force value increases to F5 The second plane edge partially penetrates the membrane material
6 The second half-surface edge completely penetrates the membrane material
7 The ...-plane edge expands the membrane material, force value increases to F8 Needle tube friction movement, force value decreases to 1
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