Some standard content:
GB15810—2001
This standard is equivalent to IS07886-1:1993 "Sterile hypodermic syringes for single use Part 1: Manual syringes", and is also a revised version of CB15810—1995.
The main technical differences between this standard and IS07886-1:1993 are as follows: This standard adds sterility and pyrogen in biological performance and cytotoxicity, sensitization, irritation, hemolysis and acute systemic toxicity in biological evaluation. The requirements for reducing substances (oxidizable substances) in chemical properties are made from the part of Appendix F in 1S07886-1:1993 as the content of the standard. The sliding performance is made from Appendix G in the original ISO) 7886-1:1993 as the formal content of the standard, and the ethylene oxide residue and Appendix (Inspection Rules) are added. Editorial changes are made to Appendix A to Appendix J in 1S07886-1:1993, and the guide and references of the materials are retained.
The main technical differences between this standard and GB5810-L99 are as follows: In the biological properties in this standard, according to GB/T GB16886.1-1997 stipulates that acute systemic toxicity is added and abnormal toxicity is cancelled. Sterility, non-pyrogen, hemolysis, and intradermal irritation in the original national standard are retained, and cytotoxicity and tenderness are added. The requirements for the residual amount of propylene oxide are added to the chemical properties. The capacity tolerance is in accordance with the requirements of international standards. This standard replaces GB15810-1995 from the date of implementation. Appendices A, B, C and D of this standard are all appendices to the standard. Appendices E and F of this standard are informative appendices. This standard is currently under the jurisdiction of the State Drug Administration. This standard is under the jurisdiction of the National Medical Syringe (Needle) Standardization Technical Committee. The drafting unit of this standard: Shanghai Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration. The main drafters of this standard: Fu Guobao and Zhao Jing. This standard was first issued in 1987 and revised for the first time in 1995. 395
GB15810—2001
ISO (International Organization for Standardization) is a world-wide federation composed of national standardization bodies (ISO member bodies). The work of formulating international standards is usually completed by ISO's technical committees: if each member body is interested in a 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 can also participate in related work. In the field of electrotechnical standardization, ISO maintains a close working relationship with the International Electrotechnical Commission (IEC). The international standard drafts formally adopted by the technical committee are 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 international standard ISO7886-1 was developed by the ISO/TC84 Technical Committee for Injectable Medical Devices, SC1 Disposable Syringes, Needles and Intravascular Catheters. The first edition of ISO 7886-1 canceled and replaced ISO 7886:1984. This standard is divided into two parts. ISO 7886-1 basically retains the scope of ISO 7886:1984, and ISO 7886-2 (under development) is applicable to sterile syringes for potable use with powered syringe pumps. The main differences between this standard and ISO 7886:1984 are as follows: a) In order to consider the demand for syringe size, unlike the contents listed in ISO 7886:1981, this standard does not specify the range of syringe sizes and allows the syringe scale to be larger than the nominal capacity. b>Introduced a method for testing the force required to push the lever as a supplementary Appendix C) The test for toxicity in ISO7886:1984 is now changed to refer to S010993-1. d) The reference appendix on the method for testing the incompatibility between syringes and injections has been revised. e) This standard allows the use of the ISO symbol "Do not reuse" on the packaging label, but written text is still required. Manufacturers are encouraged to use this symbol to increase the familiarity of purchasers and users with the procedure. Under the general title of single-use sterile syringes, ISO7886 consists of the following parts: Part 1: Manual syringes
Part 2: Syringes with syringe pumps
Appendix A, Appendix B, Appendix C and Appendix D are integral parts of this standard. Appendix E, Appendix F, Appendix G and Appendix H are for reference only. 396
GB158102001
This standard does not provide requirements or test methods for protection against biological hazards. ISO 10993-1 provides guidance on biological testing for hypodermic syringes and recommends that manufacturers consider this guidance when evaluating their products. Such evaluation should include the impact of the syringe sterilization process. However, in some countries, there are national regulations that do not take into account the content of ISO 10993-1 guidance. Because each manufacturer's design, production process and sterilization method are different, the materials used to make syringes are not specified. Some guidance on material selection is provided in Annex E. The material of the syringe should be compatible with the injection liquid. If this is not the case, a label F: should be added to the primary packaging to draw the user's attention. It is impractical to specify a universally applicable method for incompatibility. However, recommended methods are provided in Annexes. These test methods can only be used as a method to indicate incompatibility. The only definitive test is the test performed with a specific injection liquid and a specific syringe.
Pharmaceutical companies use solutions in the preparation of injections. Whether the solution is compatible with the materials commonly used to make syringes can be tested by the manufacturer of the preparation. Some widely accepted materials are listed in Annex E. If incompatibility exists, the injection should be labeled appropriately. Considering that it is impossible to test any injection with all approved syringes, it is strongly recommended that regulatory authorities and relevant business groups should be aware of this problem and take appropriate measures to assist manufacturers. The subcutaneous syringes specified in this standard are intended to be used with the subcutaneous needles specified in GB15811. This standard does not involve syringes for insulin injection (see S08537). In some countries, national pharmacopoeias or government regulations are legally binding. These requirements may take precedence over this standard. $97
National Standard of the People's Republic of China
Sterile hypodermic syringes for single use
Sterile hypodermic syringes for single useGB15810—2001
eqIS07886-1:1993
Replaces B15810—1995
This standard specifies the classification and naming, requirements, test methods, inspection rules, packaging, marking, etc. of sterile syringes for single use (hereinafter referred to as syringes)
This standard applies to manual syringes for aspirating liquid or for immediate injection after liquid injection. This standard does not apply to insulin syringes, glass syringes, permanent gauge syringes, syringes with power-driven injection pumps, syringes pre-filled with liquid by the manufacturer, and syringes matched with liquid. 2 Reference standards
The provisions contained in the following standards constitute the provisions recommended by this standard through reference in this standard. When this standard is released, the versions shown are all valid. All standards will be revised: 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) class connector Part 1: General requirements (idt ISO 594-1:1986)
GB/T 1962.2-2001
Syringes, needles and other medical devices 6 for (Zenger) cone connector Part 2: Locking connector (idt IS0 GB2828-1987 Sampling procedures and sampling tables for batch inspection (applicable to inspection of continuous batches) GB2829:1987 Sampling procedures and sampling tables for periodic inspection (applicable to inspection of production process stability) GBG682-1992 Specifications and test methods for water used in analytical laboratories GB/T14233.11998 Inspection methods for medical infusion, transfusion and injection equipment Part 1: Chemical analysis methods GB/T 11233.2-1993
GB/T 16886.1—2001
Testing and treatment of medical transfusion, blood transfusion and injection equipment, Part 2; Biological test methods for biological evaluation of medical devices Part 1: Evaluation and testing (idtIS0) 109931:1997) YY/T0243—1996
Rubber pistons for disposable sterile syringes YY/T 0313—1998 Packaging, marking, transportation and storage of medical polymer products 3 Definitions
For the purpose of this standard, the following definitions are adopted 3.1 Nominal capacity nominalcapacity The capacity of the syringe indicated by the manufacturer.
Note: For example, 1 ml..5 ml., Trl..
3.2 Graduated capacity graduatedcapacity The volume of water at a temperature of 20±5°C that is discharged from the syringe when the reference line of the piston moves axially by one or several given scale intervals.
3.3 Total graduated capacity tutal graduated rapacity The capacity of the syringe between the zero scale line and the farthest scale line. : The total graduated capacity may be equal to or greater than the nominal capacity. Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on September 18, 2001 398
Implementation on February 1, 2002
GB 158102001
3.4 Maximum usable capacity Maximum usable capacity The capacity of the syringe when the piston is pulled out to its farthest functional position. 3.5 Fiducial line
The wooden end of the piston is used to determine the circular line corresponding to the capacity of any scale reading of the syringe. 4 Classification and naming
4.1 The names and terms of the various parts of the syringe are shown in Figure 1. m
1-equal scale line; 2-division capacity line; 3-nominal capacity scale line 1 total scale capacity line: 5 datum line; G-jacket curling; 7-cone cap; 8-chain head hole; 9-cone head; 1G-jacket; 11-piston: 12-sealing diagram: 13-core rod: 14-hand note; This schematic diagram only illustrates the structure of the syringe, and is not the only type specified in the standard. Figure 1 Disposable sterile syringe
4.2 The types of syringes are middle head type, tilted head type, etc., and their structures are two pieces and three pieces. 4.3 The material requirements of syringes are shown in Appendix F (Reminder Appendix). 4.4 The syringe should be lubricated with a lubricant that meets medical requirements 399
5 Requirements
5.1 Appearance
GB 158102001
5-1. 1 The syringe should be clean and free of particles and foreign matter under an illumination of 300 1x~~700 1x. 5.1.2 The syringe should not have defects such as burrs, burrs, plastic flow, defects, etc. 5.1.3 The outer jacket of the syringe should have sufficient transparency. The baseline can be clearly seen. 5.1.4 The inner surface of the syringe (including the rubber piston) should not have obvious visible lubricant pooling 5.2 Syringe scale
5.2.1 The syringe has one scale or more than one identical scale, and the scale should comply with the provisions of Table 1. Table "Nominal capacity and corresponding requirements
Syringe
Nominal capacity
20≤V30
S0SV5n
Capacity allowed
Less than the nominal
Capacity maximum
+(V1. 5%+2% of the discharge volume)
up (1.5% of V+2% of the discharge volume)
up (1.5% of V+1% of the discharge volume)
±(1.5% of V+1% of the discharge volume)
Wang (1.5 of V+1% of the discharge volume)
Two (1.5% of V+1% of the discharge volume)
Three (1.5% of V+approximately equal to or greater than the nominal volume) 15% of mountain volume
discharge volume
discharge volume
±1%
discharge volume
upper 1%
non-volume
upper 4%
non-discharge volume
discharge volume
±1%
to the nominal capacity mark
division||minimum total length
division value
calculation number
maximum
force||for||discharge
(15%)|| tt||Axial pressure
(gauge pressure)
(±5%)
5.2.2 The syringe is allowed to extend the additional scale outside the nominal capacity scale. The extended additional scale should be distinguished from the nominal capacity scale. The distinguishing methods are as follows:
a) Circle the measurement digits of the nominal capacity; b) The measurement digits of the additional scale are represented by a smaller measurement digit bundle; c) The graduation capacity line of the additional scale is represented by a shorter scale line; d) The vertical line of the additional scale length is represented by a dotted line. 5.3 Scale inventory line
5.3.1 The scale should be as specified in Table 1 The graduation value indicates the scale capacity line. 5.32 The printing position of the zero line should be tangent to the inner edge line of the outer sleeve bottom seal. When the core rod is fully pushed into the end of the outer sleeve bottom seal, the zero line should coincide with the base push line on the piston. The error must be within one-fourth of the minimum graduation interval. 5.3.3 The scale capacity lines should be evenly spaced along the long axis of the outer sleeve between the zero line and the total capacity scale line. 5.3.4 When the syringe is kept in a vertical position, the ends of all equal-length scale lines should be aligned with each other in the vertical direction. 5.3.5 The length of the secondary scale capacity line is approximately half of the main scale capacity line. 5.4 The measurement numbers on the ruler
GR 15810—2001
5.4.1 Hold the syringe vertically, with the cone head facing the measuring number. The measuring number should be in the shape of a positive or positive school. 5.4.2 The measuring number on the ruler should intersect with the extension line of the end of the corresponding scale capacity line, and should not touch. 5.4.3 The arrangement order of the measuring numbers should start from the zero line at the bottom end of the jacket cover. The "zero" can be omitted. Examples of measuring numbers marked on various specifications of injectors are shown in Figure 2.
: The vertical line of the ruler can be omitted.
5.5 Printing of the ruler
Llulmld
.-- 10
Examples of ruler scales in the figure
5.5.1 For a deflected head syringe, the ruler should be printed on the side opposite to the cone head. 5.5.2 For a mid-head syringe, the ruler should be printed on either side of the short axis of the jacket curling. 10
5.5.3 The graduation capacity lines and measurement numbers of the scale should be complete, with clear handwriting, clear lines, and uniform thickness. 5.6 Outer jacket
5.6.1 The maximum capacity length of the syringe outer jacket should be at least 10% longer than the nominal capacity length10
5.6.2 The opening of the syringe outer jacket should have a curling edge to ensure that the syringe can be placed on a plane with an angle of 10° to the horizontal and cannot be rotated more than 180%
5.7 Distance between buttons
When the core rod is completely pushed into the bottom of the outer jacket, the reference line of the piston coincides with the zero line, and the preferred minimum length from the inner surface of the curling edge to the outer surface of the button should meet the spacing specified in Table 2. See Figure 3 for details. Table 2
Handle dimensions
V.mL
Handle dimensions diagram
5.8 Pistons
GB 15810—2001
5.8.1 The rubber piston shall be free of rubber threads, rubber scraps, foreign impurities, and frost, and shall comply with the provisions of YY/T0243. Pistons made of other materials shall comply with the provisions of the corresponding standards.
5.8.2 The piston shall fit the outer cover. When the syringe is filled with water and kept vertical, the support shall not move due to its own weight. 5.9 Cone
5.9.1 The diameter of the taper hole shall not be less than 1.2mm. 5.9.2 The outer taper joint bottom of the syringe chain head shall comply with the provisions of GB/T1962.1 or GB/T1962.2. 5.9.3 For a mid-head syringe, the taper head shall be located at the center of the bottom end of the outer jacket and on the same axis as the outer jacket. 5.9.4 For offset-head syringes, the cone head should be off-center on the bottom cover of the outer jacket and should be located on the center line of the side of the short axis of the outer jacket curling, and the distance between the axis of the cone head and the nearest point of the inner wall of the outer jacket should not be less than 4.5 mm. 5.10 Physical properties 5.10.1 The syringe should have good sliding properties, and its push and pull forces should comply with the requirements of Table 3. Table 3 Sliding properties
Nominal capacity of syringe
Starting force
5.10.2 Body tightness
Average force
Maximum push-back force
≤ (2.0X measured F) or (measured F
1.5N) whichever is higher
(2.0× full mother) or (measured F+
1.5V) whichever is higher
(2.0×) (measured F+
1.5V) whichever is higher
Minimum push-back force
≥ (0.5× measured F) or < measured F-
1.5V) 5N> the more likely one
(). 5 × measurement F) or (measurement F-
1.5N, whichever is lower
(0. G×measurement product) or (measurement F
1. 5N), whichever is lower
Inhale the nominal volume of water into the syringe, and apply the axial pressure and lateral force specified in Table 1 to the core rod for 30s. There shall be no leakage at the contact point between the outer sleeve and the piston.
Maintain 60s+5s under the negative pressure of 88kPa, and there shall be no leakage at the contact point between the outer sleeve and the piston, and the piston and the core rod shall not separate.
5.10.3 Capacity tolerance: The maximum tolerance of 1/2 of the nominal capacity and 1/2 of the nominal capacity shall comply with the relevant provisions in Table 1.
5.10.4 Residual volume: When the core rod is fully pushed into the bottom of the outer sleeve, the liquid volume remaining in the outer sleeve shall not exceed the provisions in Table 1. 5.11 Chemical properties
5.11.1 Extractable metal content: The syringe extract is compared with the blank control solution of the same batch. The total content of lead, zinc, tin and iron should be 5/ml. The content of cadmium should be ≤0.1μg/ml.
5. 11.2 Acidity: The pH value of the syringe extract is compared with the blank control solution of the same batch. The difference in pH value shall not exceed 1.0. 5.11.3 Oxidizing agent: The difference in the consumption of 0.002 101/L potassium permanganate solution between the syringe extract and the blank control solution of the same volume of the same batch shall be 0.51L.
5.11.4 Residual amount of cyclohexane 21. The residual amount of cyclohexane should be 10/g. Sample description:
115078861:1993 This item is a prompt requirement. 2_1507886-1:1993 does not have this technical index. 402
5.12 Biological properties:
5.12.1 The syringe should be photobacterial
5.12.2 The syringe should be pyrogenic.
GB 15810—2001
5.12.3 Hemolysis: The syringe should have no hemolysis reaction (hemolysis rate 3%), 5.12.4 Acute systemic toxicity: The syringe should have no acute systemic toxicity. 6 Test method
6.1 Appearance
Observe by day. The composition shall comply with the provisions of 5.1, 5.2.2.5.3, 5.4, 5.5, 5.8 and 5.9.3. 6.2 Dimensions
Use general or special measuring tools. The measurement shall comply with the provisions of 5.2.1, 5.6.1, 5.7, 5.5.1 and 5.9.4. 6.3. Flanging
Use an inclined plane with an angle of 10° to the horizontal, and place the syringe parallel to the inclined plane. The requirements of 5.6.2 shall be met. 6.4 Sliding performance
Perform the method in Appendix A and meet the requirements of 5.10.1. 6.5 External cylindrical joint test
Perform the method in GR/1962.1 or GB/T1962.2 and meet the requirements of 5.9.2. 6.6 Tightness of syringe body
Fill the syringe with water of nominal capacity and seal the cone hole. Apply the force (3) (8+58) specified in Table 1 to the core rod and observe for leakage. Adjust the water to a position not less than 25% of the nominal penetration. Move the cone to 1: and withdraw the piston so that the reference line coincides with the nominal penetration line. When the negative pressure reaches 88 kPa from the cone hole, maintain it for 60-5s and observe the force. It shall comply with the requirements of 5.10.2. 6.7 Capacity tolerance test
Use a balance with an accuracy of 0.1u to weigh the empty broken glass cup, and use a syringe to draw 20℃±5℃ distilled water to the scale capacity V. Select any point in the range of greater than (including equal to) and less than half of the nominal capacity. Expel bubbles and ensure that the half-moon-shaped water surface of the water is flush with the wooden end of the cone head cavity, and at the same time, the upper edge of the reference line is tangent to the lower edge of the graduation line. Then, all the water is discharged into the empty glass cup, and the mass is weighed again. The difference between the two is the discharged volume (V,, the water density is 1 001kg/m) V:- Vi
The calculation formula for the capacity tolerance (%) greater than or equal to half of the nominal capacity is: × 100%
Where: V-scale capacity:
V.—discharge volume.
In addition, the capacity tolerance V of the small Ding half of the nominal capacity. -V, should meet the requirements of 5.10.3, 6.8 Residual capacity test
Use a large flat plate with an accuracy of 0.1 mm to weigh the empty syringe, fill the syringe with 20C-5C distilled water to the nominal capacity scale, carefully expel all bubbles and ensure that the half-moon level of the water is flush with the end of the cone head cavity. Then completely press the core cup to expel the water and wipe the outer surface of the syringe, and re-weigh the syringe. Subtract the mass of the empty syringe from the mass of the syringe after the water is discharged to obtain the mass of water remaining in the syringe in grams (g), which is the residual amount and is expressed in milliliters (rmL). The density of water is 1 kkg/m and should be in accordance with the provisions of 5.10.4.
6.9 Chemical properties
6.9.1 Preparation of test solution
Perform according to method No. 4 in Table 1 of GB/T14233.1-1998. Note:
This technical indicator does not exist in GB/T14233.1-1998, and is only explained in the introduction of [50]. 4n3
6.9.2 Metal content in the steel
GB 15810—2001
Use the method in 6.9.1, and the test amount obtained after 8 hours of leaching shall be measured according to the method in 5.6 of GB/T14233.1-1998, and shall comply with the provisions in 5.11.1. The content of ferrous metal shall be measured according to the method in 5.5.1 of GB/T14233.1--1998, and shall comply with the provisions in 5.11.1. 6.9.3 pH
Use the method in 6.9.1, take the test solution obtained after 8 hours, and then proceed with the method in 5.4.1 of GB/I14233.1-1998, which shall comply with the provisions of 5.11.2:
6.9.4 Oxidizable substances
Use the method in 6.9.1, take 20ml of the test solution obtained after 1 hour, and proceed with the method in 5.2.2 of CB/T14233.1-1998, which shall comply with the provisions of 5.12.3
6. 9.5 Preparation of ethylene oxide residual test solution: Take the syringe and weigh it accurately (m), inject the grade 3 water in accordance with GB6682-1992 into the syringe to the nominal capacity (V), keep it at 37°C±1°C for 1h, take a certain amount of leaching solution, and test it according to the gas chromatography method in Chapter 9 of GB/T14233.11998. The corresponding sample concentration (c) is obtained from the standard curve, and the ethylene oxide content W of the syringe is calculated according to the formula. W should meet the requirements of 5.11.4.
W(μg/g) =- =xy
6.10 Biological properties
6.10.1 Sterility test
Take 6 sample injectors, draw 0.9% sodium chloride injection solution into the syringe in the sterile room to the total scale capacity, pull back the core rod, and vibrate the piston slightly away from the liquid surface for 5 times. The test shall be carried out according to the sterility test method in GB/114233.2-1993 and shall comply with the provisions of 5.12.1. 6.10.2 Pyrogen test
a) Rabbit test method (arbitration method)
It shall be carried out according to the pyrogen test method in GB/T14233.2-1993. b) Bacterial endotoxin test
Take at least 3 syringes, draw pyrogen-free water or 0.9% sodium chloride injection to the total scale, pull the core rod back to the opening of the jacket, wash twice with liquid, seal in a 37°C ± 2°C (constant temperature box, keep for 2 hours, take out and collect the test solution in the syringe in a pyrogen-free glass container. The test solution should not be stored for more than 2 hours, and the relevant method of GIB/T14233.2 should be carried out. It should comply with the provisions of 5.12.2. 6. 10.3 Hemolysis
The hemolysis test should be carried out according to the method in Appendix 3 and should comply with the provisions of 5.12.3. 6. 10.4 Acute systemic toxicity test
It shall be carried out according to the relevant methods in B/114233.2 and shall comply with the provisions of 5.12.4; 7 Packaging
7.1 Single packaging
Each syringe shall be packaged in a single packaging. The packaging materials shall not have a harmful effect on the contents. The materials and design of this packaging shall 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 packaging; c) the contents are fully protected during handling, transportation and storage; d) once opened, the packaging cannot be easily resealed and there should be obvious signs of being torn. 7.2 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. 4C4bzxZ.net
GB15810—2001
One or more secondary packages can be packed into a secondary packaging. 8 Marking
All marking symbols should comply with the provisions of YY/T0313. 8.1 Single Package
Single package shall bear at least the following labels:
a) Description of contents, including nominal capacity;
b) "Non-pyrogen" or "Non-pyrogen";
c) "Single use" or equivalent words;
d) Warning of solvent incompatibility, if necessary;
e) Batch number beginning with "batch";
Name and address of manufacturer or supplier;
g) Year and month of expiration date;
h) Injectable needles for radix ophiopogonis, with specification indicated;||t i) Check each package before use. · Warning of the integrity of the single package. 8.2 Secondary packaging
The secondary package should have the following markings:
a) Description of the contents, including the nominal capacity and quantity; b) "sterile";
c) "single use" or equivalent:
d) Batch number starting with "batch";
e) Year and month of expiration date;
f) Name and address of the manufacturer or supplier; g) If it is just injected, the specification should be indicated.
8.3 Large packaging
If the medium packaging is packed into the large packaging, the large packaging shall bear the following marks: a) Description of the contents as specified in 8.2el); b) Batch number beginning with "batch"; c) "sterile"; d) Year and month of expiration date; d) Name and address of the manufacturer or supplier; 3) Requirements for handling, storage and transportation.
8.4 Transport packaging materials
If large packaging is not used, but the medium packaging is packed for transportation, the contents required by 8.3 shall be marked on the transport packaging materials, or the name shall be visible through the packaging materials. 8.3 Requirements 9 Storage
Sterilized syringes should be stored in a well-ventilated room with a humidity not exceeding 80%, no corrosive gases, and adequate protection for the syringes.
A1 Principle
GB158102001
Appendix A
(Appendix of the standard)
Sliding performance test method
The mechanical tester shown in Figure A1 is used to move the core rod of the syringe to draw in or discharge water, while recording the applied force and the movement of the core rod.
1 Mechanical test hypothesis The change of its: 2 horizontal plane is about the point of the river shooting: 3. The syringe being tilted: 4 water tank (2.2) 5 water (A2.S) 16-connection catheter (A2.2) 17-adjustment device suitable for different nominal capacity of the river shooter Figure A1 Device for testing the push and pull force of the operating core rod A2 Device and solution
A2.1 Mechanical tester: can measure and continuously record the size of the force, the accuracy is 1% of the full scale, and can fix the syringe being tested. A2.2 Water tank: connected to the atmosphere, the inner diameter of the catheter connected to the syringe being tested is 2.7mm and 0.1mm. 406
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