Some standard content:
GB15811—2001
This standard is equivalent to ISO7864:1993 "Single-use sterile injection needles". It is also a revised version of GB158111995. The main technical differences between this standard and IS07864:1993 are as follows: This standard adds the requirements for needle sharpness in the physical properties, and adds inspection rules. Editorial changes have been made to Appendix A to Appendix D in IS07861:1993. The main technical differences between this standard and GB 15811-1995 are as follows: The original standard was not equivalent, but it is now equivalent. According to the provisions of GB/T 16886.1997, the abnormal toxicity index is cancelled, and cytotoxicity, sensitization, irritation, hemolysis and acute systemic toxicity are added. Sterility and non-pyrogen are retained. The physical properties mainly add the requirements for needle sharpness. The specifications adopt the international standard 0.3mm~1.2mm, and type inspection is added. This standard replaces GB15811-1995 from the date of implementation. Appendix A, Appendix II and Appendix C of this standard are all standard appendices. Appendix I of this standard is a reminder appendix. This standard is proposed by the State Food and Drug Administration and is under the jurisdiction of the National Technical Committee for Standardization of Medical Syringes (Needles). The drafting unit of this standard is: Shanghai Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration. The main drafters of this standard are: Fu Guobao and Zhao Jing. This standard was first issued in 1987 and revised for the first time in 1995. 412
G158112001
ISO Foreword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization bodies (IS) member groups. The work of formulating international standards is usually completed by ISO's technical committees. If each member group is interested in the standard items established by a technical committee, it has the right to participate in the work of the committee. International organizations (other or non-official) that maintain contact with ISO may also participate in the relevant work. In the field of electrotechnical standardization, ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IEC). The draft international standard formally adopted by the technical committee is submitted to the member groups for voting. The international standard needs to obtain the consent of at least 75% of the member groups participating in the voting before it can be formally adopted. The third edition of the international standard ISO 7864, prepared by the ISO/TC84 Technical Committee for Injectable Medical Devices, SC1-Disposable Syringes, Needles and Intravascular Catheters, cancels and replaces the second edition (ISO 7864:1988) and makes technical revisions to it. The main differences between this edition and the 1988 edition are as follows: a) This international standard stipulates that the use of needles and tubes shall comply with ISO 9626. Since ISO 9626 provides requirements for metal materials (hardness, toughness and corrosion resistance), these requirements are eliminated in this international standard. The formulation of ISO 9626 also allows the introduction of new needles and tubes with smaller outer diameters, thin-walled and ultra-thin-walled tubes in the international standard. In order to avoid inhibiting innovation, this International Standard no longer recommends combinations of needle diameters and lengths. h) The shape and cross-sectional characteristics of the needle tip have been described in the appendix and guidelines. A large number of relevant biological tests are listed in the appendix to replace the toxicity tests given in the 1988 edition. ) This International Standard allows the use of the ISO symbol "not to be reused" on packaging labels, but a literature description is still required. Manufacturers are encouraged to use this symbol to increase their familiarity with it by buyers and users. Appendix A is a composite part of this International Standard. Appendix B, Appendix C and Appendix D are for reference only. 413
GB15811—2001
This standard deals with disposable sterile hypodermic needles intended primarily for human use. This standard does not provide requirements and test methods for protection against biological hazards because international agreement on methods and criteria is not yet complete. ISO 10993-1 provides guidance on biological tests for hypodermic needles and recommends that manufacturers consider the contents of this guide when evaluating their products. Such evaluation should include the impact of the needle sterilization process. However, in some countries there are national regulations which override the guidance in ISO 5010993-1.
The plastic material selected for needle manufacture is not specified, as the design, production process and sterilization methods vary from manufacturer to manufacturer. The material should be compatible with the injection fluids in the relevant pharmacopoeias. The hypodermic needles specified in this International Standard are intended for use with hypodermic syringes as specified in ISO 595 and ISO 7886-1. They are also applicable to type 1 and type 2 syringes as specified in ISO 8537. In some countries, national pharmacopoeias or government regulations are legally binding and these requirements may take precedence over the International Standard. 414
1 Scope
National Standard of the People's Republic of China
Sterile hypodermic needles for single use
Sterile hypodermic needles for single useGB15811:2001
eqv IS0 7864: 1993
Generation GB 13811—1995
This standard specifies the classification and naming, requirements, test methods, inspection rules, packaging and marking of single-use sterile hypodermic needles (hereinafter referred to as hypodermic needles) with a nominal outer diameter of 0.3mm to 1.2mm. This standard applies to hypodermic needles used for intradermal, subcutaneous, intramuscular, intravenous injection or extraction of fluids. 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 the parties using this standard should explore the possibility of using the latest versions of the following standards. GB/T 1962.1-2001 Syringes, needles and other medical devices 6% (Luer) cone connectors Part 1: Requirements for use (idt ISO 594-1:1986)
GB/T 1962.2-200 Syringes, needles and other medical devices 6% (Luer) cone connectors Part 2: Locking connectors (idt 1S0 394-2: 1998)
GB2828-1987 Batch inspection counting sampling procedure and sampling table (applicable to the inspection of continuous batches) GB2829-1987 Periodic inspection counting sampling procedure and sampling table (applicable to the inspection of production process stability) GB6682-1992 Specifications and test methods for water used in analytical laboratories GB3/T14233.1-1998 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical test methods GB/T14233.2-1993 Inspection methods for medical infusion, blood transfusion and injection equipment Part 2: Biological test methods Biological evaluation of medical devices Part 1: Evaluation and testing (idtIS010993-1: 1997) GB/1 16886. 1-2001
GB18457--2001 Stainless steel needles for medical equipment (CVIS () 9626: 1991) YY0242--1996 Polypropylene special materials for medical infusion, blood transfusion and syringes YY/T 0296--1997
Disposable injection: identification color code (IDT1S06009: 1992) YY/T0313-1998
Medical polymer products packaging. Marking. Transportation and storage 3 Classification and naming
3.1 The names and types of the various parts of the injection needle shall comply with the provisions of Figure 1. 3.2 The geometrical pattern and naming of the needle tip shall comply with the provisions of Figure 2. 3.3 Product marking: The marking of injection needle products is expressed by the outer diameter, length, wall type and blade angle of the needle tube. The outer diameter and length unit is expressed in "mm", the wall type is expressed in RW (normal wall), TW (thin wall) or ETW (extra thin wall), and the blade angle is expressed in LB (long bevel angle) or SI3 (short bevel angle).
Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on September 18, 2001 and implemented on February 1, 2002
Marking example: 0.7×30
GB 15811—2001
Long bevel angle
3.4 The needle tube of the injection needle should be made of the materials specified in GB18157. 3.5 The first bevel angle of the needle tip (as shown in Figure 2) is usually 11°±2° (IB) or 17±2° (SB). 3.6 The needle seat material should be polyolefins that comply with YY02421996 or other polymer materials that have side effects on the human body. 1 Needle seat 2 Connecting part Needle tube 4 Sheath
Injection needle is rotated at an angle
The schematic diagram of the disposable sterile injection needle and sheath shows the difference when the first bevel
crosses the needle tip
d, a-tube outer diameter di-tube inner diameter; A-needle tip length; B.-first bevel nominal length; B:1. Right first material surface length: B2 2. Left first bevel length; C—Nominal length of second bevel; Cl—Length between second bevels C—Length of second bevel on the left, α 3. Right first bevel angle: 4. Left second bevel angle: 5. Needle tip angle: 6. Right first bevel angle: 7. Left second bevel angle: 8. Combined second bevel angle
Figure 2 Needle tip geometry and naming
4. Requirements
4.1 External specification
GB15811-2001
4.1.1 The needle tube of the injection needle should be clean and free of debris, and the needle tube should be straight. 4.1.2 The needle seat should be free of obvious injection defects such as burrs, burrs, plastic flow and bubbles. 4.1.3 The cone hole of the needle seat should be free of particles and impurities. 4.1.4 The needle tip must be free of defects such as burrs and hooks. 4.2 Dimensions
4.2.7 The outer diameter of the needle tube of the injection needle shall comply with the provisions of Table 1 of GB 18457-2001. 4.2.2 The length of the needle tube of the injection needle shall comply with the provisions of Table 1. Table 1 Basic dimensions
Nominal length of the needle tube Factory
4.3 Needle tube of the injection needle
Limit deviation
4.3.1 Rigidity: The injection needle shall have good rigidity. When tested under the conditions specified in Table 2 of GB 18457-2001, the maximum deflection value of the needle tube shall comply with the provisions of Table 2 of GB 18457-2001. 4.3.2 Toughness: The injection needle shall have good toughness. The seat shall be bent repeatedly in two directions in one plane according to the span specified in Table 3 of GB 18457-2001 and the number of cycles specified in Appendix I) according to the swing angle specified in Appendix D of GB 18457-2001, and shall not break. 4.3.3 Corrosion resistance; the injection needle should have good corrosion resistance. 4.3.4 When lubricant is used on the surface of the needle tube, no droplets should be formed on the surface of the needle tube by visual observation. 4.3.5 The inside of the needle tube should be clean, and the mixed liquid flowing through the inner wall of the needle tube should be free of foreign matter and dirt. 4.4 Injection needle seat
4.4.1 The conical joint of the injection needle seat should comply with the provisions of GB/T1962.1 or GB/T1962.2. 4.4.2 The color of the injection needle seat should comply with the provisions of YY/T0296. 4.4.3 The connection between the injection needle seat and the needle tube should be straight and not obviously skewed. 4.44 The connection between the needle holder and the needle tube should be firm. Under the tensile force specified in Table 2, the two should not be loose or separated. 4.4.5 The needle holder and the sheath should be well matched. The sheath should not fall off naturally, and the separation force between the two should not be greater than 15N. 4.4.6 The needle hole of the injection needle should be unobstructed. The needle specified in Table 3 can pass freely. Or under a water pressure of no more than 100 kPa, the flow rate should be no less than 80% of the flow rate of the needle tube with the same outer diameter and length and the minimum inner diameter specified in GB18457-201 under the same conditions. 17 ISO7864:1993 does not have this technical indicator. ar?
Size + mm
GB15811—2001
Table 2 Needle and needle tube are firmly connected
Table 3 Needle diameter
Diameter of the needle
Normal wall
Door, 49
Ultra-thin wall
CB 158112001
4.5 The tip of the injection needle should be sharp, and its maximum piercing force should comply with the requirements of Table 4 2 Table 4 Piercing force
Size mm
4.6 Chemical properties
Piercing force, N
Specification mm
0.7--0. 9
1. 1~ 1. 2
4.6.1 pH: The test solution of the injection needle should be compared with the control solution of the same batch, and the difference in pH value shall not be greater than 1. 4.6.2 Extractable metal content: The total extractable metal content in the test solution of the injection needle shall not exceed 5μg/mL, and the content of the pot shall be less than 0.1 ug/ml. 4.7 Biological properties 4.7.1 The injection needle shall be sterile. 4.7.2 The injection needle shall be free of pyrogens. 4.7.3 Hemolysis: The injection needle shall not have hemolytic reaction. 4.7.4 Acute systemic toxicity: The injection needle shall not have acute systemic toxicity. 5 Test methods 5.1 Appearance 5.1.1 Observation by force shall comply with the provisions of 4.1.1, 4.1.2, 4.3.4.4.4.2 and 4.4.3. 5.1.2 Observation by 3x magnifying glass shall comply with the provisions of 4.1.3 and 4.1.4. 5.2 Dimensions: Measured with general or special measuring tools, shall comply with the provisions of 4.2. 5.3 Injection needle tube
5.3.1 Rigidity test: Performed according to the method in Appendix C of GB18457-2001, shall comply with the provisions of 4.3.1. 5.3.2 Toughness test: Performed according to the method in (Appendix of GB18457-2001), shall comply with the provisions of 4.3.2. 5.3.3 Corrosion resistance test: Performed according to the method in Appendix E of GB18457-2001, shall comply with the provisions of 4.3.3. 5.3.4 Foreign matter test on the inner surface of the needle tube: Mix glycerol and alcohol (1:1) evenly, then use a clean syringe to inject 5ml of the mixture through the injection needle, observe whether it complies with the provisions of 4.3.5. 5.4 Needle holder for injection needle
5.4.1 The round joint of the needle body of the injection needle shall be tested according to the method in GI3/T1962.1 or GB/T1962.2. It shall comply with the provisions of 4.4.1.
5.4.2 Connection firmness test: Fix the needle tube of the injection needle on the special instrument 1, and pull it out without impact in the direction of the needle holder pulling out. It shall comply with the provisions of 4.4.
5.4.3 Needle holder and sheath matching test: Fix the needle holder of the injection needle on the special instrument, and pull it out without impact in the direction of the sheath pulling out. It shall comply with the provisions of 4.4.5.
5.4.4 Pinhole unblocking test: According to the provisions of Table 3, use a pinhole of corresponding specifications to conduct unblocking test, or conduct unblocking test under water pressure not exceeding 100kPa: It shall comply with the provisions of 4.4.6 (the latter is the arbitration method). 5.5 Piercing force test: It shall be conducted according to the method in Appendix A and shall comply with the provisions of 4.5. 5.6 Chemical properties
5.6.1 Preparation method of small test solution for chemical properties test There is no technical index in 211807862:1993, and this technical index is only explained in the introduction. 119
GB 15811—2001
Immerse 25 unsheathed injection needles in 250 ml of newly prepared Class 3 water towel that meets the requirements of GB6682-1992, keep it at 37°C for 1 hour, remove the injection needles to obtain the test solution; at the same time, prepare a blank control solution. 5.6.2 pH
Perform the test according to the requirements of 5.4.1 Method 1 in GB/T14233.11998, and it should meet the requirements of 4.6.1. 5.6.3 Extractable metal content
The method specified in 5.6 of GB/T14233.1-1398 shall be used. The cadmium content shall be tested according to the method specified in 5.9.1 of GB/T14233.1-1998. The test should comply with the requirements of 4.6.2. 5.7 Biological performance test
5.7.1 Preparation of biological test solution Immerse 25 needles in 250ml of sterile, pyrogen-free 0.9% sodium chloride solution and warm them at 37+℃ for 1h. Remove the needles to obtain the test solution. The storage time for the test shall not exceed 21. 5.7.2 Sterility test
According to GB/T 14233.21993 small and medium-sized accessories or entity test, 10 injection needles are directly placed in the sterile culture medium, which shall comply with the provisions of 4.? .1.
5.7.3 Photopyrogen
Take the test solution prepared in 5.7.1 and conduct it according to the bacterial endotoxin test or pyrogen test method (arbitration method) in GB/T 14233.2-1993, which shall comply with the provisions of 4.7.2. bZxz.net
5.7.4 Dissolution test
According to the relevant methods in GB/T 14233.2, which shall comply with the provisions of 4.7.3. 5.7.5 Acute systemic toxicity test
According to the relevant methods in GB/T 14233. 2, which shall comply with the provisions of 4. 7. 4 6 Packaging
6.1 Single Packaging
Each injection needle should be enclosed in a single package. The material and design of this package should ensure that the color code is visible. The packaging material must not have a harmful effect on the contents. The material and design of this package should ensure: a) the sterility of the contents can be guaranteed under dry, clean and well-ventilated storage conditions; b) the risk of contamination of the contents is minimized when the contents are taken out of the package; c) the contents are adequately protected during normal handling, transportation and storage; d) the package cannot be easily resealed after opening, and there should be obvious signs of being torn 6.2. Secondary packaging
One or more single packages should be packed into a secondary packaging. During normal handling, transportation and storage, the secondary packaging should be able to fully and effectively protect the contents. 6.3 Daily packaging
One or more secondary packages can be packed into a large package. 7. Marking
All signs and symbols should comply with the provisions of YY/T0313. 7.1 Single packaging
At least the following markings should be placed on the single packaging:
a) Description of the contents, including the size marked according to 3.3;
c) The words "sterile" and "pyrogen-free";
c) The batch number starts with "batch";
d) Name of the manufacturer or supplier:
el Expiration date year and month:
\) "Single use\ or equivalent words: GB 15811 2001
g) A warning to check the integrity of each package before use. 7.2 Medium packaging
The following markings should be on the package of the towel;
) Description of the contents, including the size, name, model or bevel angle indicated in accordance with 3.3, and the use of "thin wall" or "ultra-thin wall" or equivalent words or abbreviations when appropriate: b) "sterile";
) "-single use" or equivalent words;
d) Batch number starting with "batch";
e) Year and month of expiration date;
f) Name and address of the manufacturer or supplier, 7-3 Large packaging
If the medium packaging is packed into a large packaging, the large packaging should have the following markings: Group) According to 7.2a) Description of the specified contents b) Batch begins with "batch\"!
c) "sterile" sample;
d) Year and month of expiration date;
e) Name and address of manufacturer or supplier;) Handling, storage and transportation requirements.
7.4 Transport packaging materials
If large packaging is not used, but medium packaging is packed for transportation, the contents required by 7.3 should be marked on the transport packaging materials 1. Or the contents required by 7.3 should be visible through the packaging materials. 8 Storage
Sterilized injection needles should be stored in a room with humidity not exceeding 80%, no corrosive gas and good ventilation, and the injection needles should be fully protected.
A1 Principle
GB 15811-2001
Appendix A
(Standard Appendix)
Test method for injection needle penetration force
Use a penetration force test device to make the injection needle pass vertically through the simulated skin at a specified speed to evaluate the injection needle's penetration force.
A2 Test device and materials
A2.1 Test device
As shown in Figure A1·Other devices with the same performance and accuracy can also be used, a Transmitter unit with pressure measuring element + tb Test needle-simulated skin; d Simulation Skin clamp, measuring device, main data processing and display unit; & printer: h-floppy disk
Note: a)--f) are the basic components,
Figure A1 uses a typical test device for measuring and recording puncture force. A2.2 Composition of test device
a) Transmitter unit with pressure measuring element; b) Test needle;
c) Simulated skin
d) Simulated skin head;
t) Measuring amplifier;
f) Data processing and display unit
g) Printer:
h) Floppy disk.
A2.3 Technical indicators of test device
a) Linear drive speed: 50mm/min~250mm/min, average speed accuracy ≤±5% (set value); 422
GB15811—2001
b) Pressure sensor measurement range: 0~50 (0~～5) N, accuracy ±0.5% (full scale) A2.4 Simulated skin material
a) Material: polyurethane film;
b) Thickness: 0.35mm±0.05mm:
) Hardness: Shore A85-10;
d) Exposure area: (after clamping) equal to 10mm. A3 Test procedure
a) Place the test needle and simulated skin at 22℃=2℃ for at least 24 h, and test at the same temperature; b) According to the test device shown in Figure A1, place the simulated skin of appropriate size. Clamped on the device, no significant tension or compression should be applied to the simulated skin:
c) Mount the test needle on the device h with its axis perpendicular to the surface of the simulated skin c and the needle tip pointing to the center of the circular puncture area. a) Set the movement speed to 100mm/min. ) and start the test device.
1) Puncture the membrane and measure the maximum peak force or record the force/displacement diagram at the same time. Note: Do not use a membrane with a puncture area or a membrane that has been punctured. A4 Conformity evaluation
Compare the maximum peak value in the obtained displacement graph with the required specified value. When the maximum peak value is less than or equal to the specified value, it is determined that the piercing force of the needle under test meets the requirements.
Appendix B
(Appendix to the standard)
Inspection rules
B1 Periodic inspection (type inspection)
B1.1 Type inspection should be carried out in the following cases: A) When new products are launched, material sources or formulas and production processes are changed; b) Continuous production is repeated for more than two years; () When production is stopped for rectification and then resumed; d) When required by the contract or the management department; c) When the quality supervision department conducts supervision and random inspection on product quality, B1.2 Periodic inspection is a performance inspection. B1.3 Periodic inspection should be carried out in accordance with the provisions of G2829. B1.4 Sampling method is required from the outset! Random sampling is carried out from the qualified batches, and the number of samples to be taken is as specified in Table B1. The periodic inspection adopts a one-time sampling plan, and the classification, test red, inspection items, discrimination level, and RQL (reject quality level) of the unqualified products are as specified in Table B1.1 Test device As shown in Figure A1. Other devices with the same performance and accuracy can also be used, a Transmitter unit with pressure measuring element + tb Test needle - Simulated skin; d Simulated skin fixture e Measuring amplifier Main data processing and display unit; & Printer: h - Floppy disk Note: a)--f) are the basic components. Figure A1 uses a typical test device for measuring and recording puncture force. A2.2 Composition of test device a) Transmitter unit with pressure measuring element; b) Test needle; c) Simulated skin; d) Simulated skin head; t) Measuring amplifier; f) Data processing and display unit g) Printer; h) Floppy disk.
A2.3 Technical indicators of test device
a) Linear drive speed: 50mm/min~250mm/min, average speed accuracy ≤±5% (set value); 422
GB15811—2001
b) Pressure sensor measurement range: 0~50 (0~～5) N, accuracy ±0.5% (full scale) A2.4 Simulated skin material
a) Material: polyurethane film;
b) Thickness: 0.35mm±0.05mm:
) Hardness: Shore A85-10;
d) Exposure area: (after clamping) equal to 10mm. A3 Test procedure
a) Place the test needle and simulated skin at 22℃=2℃ for at least 24 h, and test at the same temperature; b) According to the test device shown in Figure A1, place the simulated skin of appropriate size. Clamped on the device, no significant tension or compression should be applied to the simulated skin:
c) Mount the test needle on the device h with its axis perpendicular to the surface of the simulated skin c and the needle tip pointing to the center of the circular puncture area. a) Set the movement speed to 100mm/min. ) and start the test device.
1) Puncture the membrane and measure the maximum peak force or record the force/displacement diagram at the same time. Note: Do not use a membrane with a puncture area or a membrane that has been punctured. A4 Conformity evaluation
Compare the maximum peak value in the obtained displacement graph with the required specified value. When the maximum peak value is less than or equal to the specified value, it is determined that the piercing force of the needle under test meets the requirements.
Appendix B
(Appendix to the standard)
Inspection rules
B1 Periodic inspection (type inspection)
B1.1 Type inspection should be carried out in the following cases: A) When new products are launched, material sources or formulas and production processes are changed; b) Continuous production is repeated for more than two years; () When production is stopped for rectification and then resumed; d) When required by the contract or the management department; c) When the quality supervision department conducts supervision and random inspection on product quality, B1.2 Periodic inspection is a performance inspection. B1.3 Periodic inspection should be carried out in accordance with the provisions of G2829. B1.4 Sampling method is required from the outset! Random sampling is carried out from the qualified batches, and the number of samples to be taken is as specified in Table B1. The periodic inspection adopts a one-time sampling plan, and the classification, test red, inspection items, discrimination level, and RQL (reject quality level) of the unqualified products are as specified in Table B1.1 Test device As shown in Figure A1. Other devices with the same performance and accuracy can also be used, a Transmitter unit with pressure measuring element + tb Test needle - Simulated skin; d Simulated skin fixture e Measuring amplifier Main data processing and display unit; & Printer: h - Floppy disk Note: a)--f) are the basic components. Figure A1 uses a typical test device for measuring and recording puncture force. A2.2 Composition of test device a) Transmitter unit with pressure measuring element; b) Test needle; c) Simulated skin; d) Simulated skin head; t) Measuring amplifier; f) Data processing and display unit g) Printer; h) Floppy disk.
A2.3 Technical indicators of test device
a) Linear drive speed: 50mm/min~250mm/min, average speed accuracy ≤±5% (set value); 422
GB15811—2001
b) Pressure sensor measurement range: 0~50 (0~～5) N, accuracy ±0.5% (full scale) A2.4 Simulated skin material
a) Material: polyurethane film;
b) Thickness: 0.35mm±0.05mm:
) Hardness: Shore A85-10;
d) Exposure area: (after clamping) equal to 10mm. A3 Test procedure
a) Place the test needle and simulated skin at 22℃=2℃ for at least 24 h, and test at the same temperature; b) According to the test device shown in Figure A1, place the simulated skin of appropriate size. Clamped on the device, no significant tension or compression should be applied to the simulated skin:
c) Mount the test needle on the device h with its axis perpendicular to the surface of the simulated skin c and the needle tip pointing to the center of the circular puncture area. a) Set the movement speed to 100mm/min. ) and start the test device.
1) Puncture the membrane and measure the maximum peak force or record the force/displacement diagram at the same time. Note: Do not use a membrane with a puncture area or a membrane that has been punctured. A4 Conformity evaluation
Compare the maximum peak value in the obtained displacement graph with the required specified value. When the maximum peak value is less than or equal to the specified value, it is determined that the piercing force of the needle under test meets the requirements.
Appendix B
(Appendix to the standard)
Inspection rules
B1 Periodic inspection (type inspection)
B1.1 Type inspection should be carried out in the following cases: A) When new products are launched, material sources or formulas and production processes are changed; b) Continuous production is repeated for more than two years; () When production is stopped for rectification and then resumed; d) When required by the contract or the management department; c) When the quality supervision department conducts supervision and random inspection on product quality, B1.2 Periodic inspection is a performance inspection. B1.3 Periodic inspection should be carried out in accordance with the provisions of G2829. B1.4 Sampling method is required from the outset! Random sampling is carried out from the qualified batches, and the number of samples to be taken is as specified in Table B1. The periodic inspection adopts a one-time sampling plan, and the classification, test red, inspection items, discrimination level, and RQL (reject quality level) of the unqualified products are as specified in Table B1.
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