Some standard content:
GB18457.2001
This standard adopts equivalently IS09626:1991 "Manufacturing stainless steel needle tubes for medical devices". The main technical differences between this standard and ISO 9626:1991 are as follows: In the material requirements, ISO9626:1991 standard uses the grades in ISO683-13:1986 "Heat-treated buried steel, alloy steel and uncut steel - Part 13: Forged stainless steel", and this standard adopts the stainless steel grades equivalent to the requirements of ISO9626:1991 in ISO/TR155101997 "Chemical composition of stainless steel", and adds the provisions for the manufacture of other austenitic stainless steel materials equivalent to the grades given in this standard. The equivalent grades are given in the appendix shown. In the needle tube size table, the requirements for the maximum inner diameter of normal wall, thin wall and ultra-thin wall needle tubes are cancelled, and the Gauige wire gauge specification is added (for reference). The test method of syringe pH value, the international standard adopts Tashiro titration method, this standard adopts the method in GB/T14233.11998 (acidometer method). Appendix A, Appendix B, Appendix C, Appendix D and Appendix F of this standard are all standard appendices. Appendix F of this standard is a reminder appendix.
This standard is proposed by the State Food and Drug Administration, and this standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Syringes (Needles). The responsible drafting unit of this standard is Zhejiang Kangdelai Medical Equipment Plastic Co., Ltd. The main drafters of this standard are Zhang Honghui and Dian Zengji. 426
GB18457—2001bZxz.net
ISO Foreword
1ISO (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 committee 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 can also participate in the relevant work. In the field of electrical technical standards, 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 must obtain the consent of at least 75% of the member groups participating in the vote before it can be formally adopted. The international standard ISO9626 was formulated by the ISO/TC84 Medical Syringes and Needles Technical Committee SC1 Disposable Syringes and Needles Technical Committee.
Appendix A, Appendix B, Appendix C, Appendix D and Appendix E are all standard appendices. YYKAONTKAca
National Standard of the People's Republic of China
Stainless steel needle tubing for manufacture of medical devices
Stainless steel needle tubing for manufacture of medical devices1Scope
GE 184572001
eqyIso9626.1991
This standard specifies the dimensions, surface mechanical properties of normal wall, thin wall and ultra-thin wall tubes with metric specifications of 0.3 mm to 3.4 mm and 0.6 mm to 2.1 mm.
This standard is applicable to the manufacture of needles for intradermal, subcutaneous and intramuscular injection needles for human body and rigid straight stainless steel needle tubes for other medical devices (hereinafter referred to as needle tubes).
This standard does not apply to flexible stainless steel needle tubes because their mechanical properties are different from those of rigid straight stainless steel needle tubes specified in this standard. However, manufacturers and purchasers of flexible needle tubes are encouraged to choose the dimensions specified in this standard. 2
Cited Standards
The provisions contained in the following standards constitute the provisions of this standard through reference in these standards. When this standard is published, the versions shown are valid. All standards will be revised, and the parties using this standard should explore the possibility of using the latest versions of the following standards. GB6682-1992 Specifications and test force method for water used in analytical laboratories (neqSO3696:1987) GB/114233.11998 Medical infusion and blood transfusion. Inspection methods for injection devices Part 1: Chemical analysis methods IS0/TR15510:1997 Stainless steel - Chemical composition 3 Materials
The needle tube is made of austenitic stainless steel such as X2CrNi189, X5CrNi189, X6CrNiNb1810. X5CrNiMo17122, X6CrNiMoTi17-12-2, X6CrNiMoNb17-12-2 in ISO/TR 15510, 1997, or other austenitic stainless steel equivalent to the above-mentioned steel.
4 Size
The outer diameter, inner diameter and size of the needle tube shall comply with the provisions of Table 1. Table 1 Needle tube size
Outer diameter range
0.33(29G)
0.36(280)
0. 45(26)
Normal
Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on September 18, 2001428
Needle arrow inner diameter
Ultra-throat wall
Implemented on February 1, 2002
0. 55(24G)
,9(20)
2. 1(14G)
2,413G)
3(1IG)
Outer diameter range
Specification G is the Birmingham BWG wire gauge specification,
GB 18457—2001
Table 1 (end)
2 Outside diameter range: The actual outside diameter of the needle is limited to ±0.1 mm! 5 Specification marking
The specifications of the needle tube are marked as follows: a) Indicate the outside diameter of the needle tube with imn:
b) Indicate the type of wall thickness with normal wall, thin wall or ultra-thin wall. 6 Surface
Normal wall
Observe with normal or corrected vision, the outer surface of the needle tube should be smooth and free of defects. 7 Cleanliness
Inner diameter of the needle tube
Observe with normal or corrected vision, the outer surface of the needle tube should be free of metal chips and impurities generated during the addition process. pH
When tested according to Appendix B, the difference in pH value between the test solution and the blank control solution should not exceed 1. 9 Rigidity
When tested according to the Appendix, the rigidity value of the needle tube should not be greater than that specified in Table 2. ikAoNrKAca
Normal wall
Load, N
Span, m
GB 18457—2001
Table 2 Rigidity test conditions
Maximum deflection
Span, Errn
Maximum deflection
Span, mm
Note: For those marked with *, since there is no valid data for these specifications, the rigidity value is not given. Toughness
When tested according to the Appendix force test, the needle tube shall not break. 11 Corrosion resistance
When tested according to Appendix E, there shall be no corrosion marks on the part where the needle tube is immersed. 430
Ultra-thin wall
Maximum deflection
GB18457—2001
Toughness test conditions
Distance between fixed fulcrum and load application point±0.1
YKAoNKAca-
A1 Principle
Immerse the needle in water to precipitate soluble components A2 Apparatus and reagents
GB 184572001
Appendix A
(Appendix to the standard)
Test solution preparation method
A2.1 The test water is newly made and meets the requirements of Grade 3 water specified in GB 6682--1992. A2.2 Select borosilicate glassware for laboratory use. A3 Test solution preparation procedure
43.1 Weigh 3.0g of syringe and cut it into appropriate length. Add 250ml of water (A2.1) to a glass container of appropriate capacity (A2.2) and immerse the syringe in it. Keep the water and syringe at 37+C for 1h, then remove the syringe and ensure that the water on the inner and outer surfaces of the syringe returns to the container.
A3.2 Follow the procedure described in (A3,1) without putting the syringe in the container to prepare a blank control solution. Appendix B
(Standard Appendix)
Syringe pH Test Method
B1 Take the test solution and blank control solution prepared in Appendix A and test according to Method 1 in GI3/114233.1-1998. B2 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Wall tube type of the needle tube:Normal wall, thin wall, ultra-thin wall; c) the difference between the two pII values and the judgment result; d) the test date.
Appendix ℃
(Appendix to the subject)
Test method for rigidity of needle tube
C1 Principle
Apply the specified force to the center of the specified span of the needle tube supported at both ends, and measure the deflection value of the needle tube. C2 Instrument
C2.1 Rigidity test instrument: It can apply a force of up to 60V (accuracy of ±0.1N) vertically downward on the tube through the force push rod. 132
GB18457—2001
The lower end of the force push rod is composed of a wedge with a 60° angle and a circular support surface with a curvature radius of 1mm. The width of the push rod is at least 5mm. Figure c1 shows an example of a suitable instrument.
Picking 4 dishes
Adjustable span
Figure C1 Rigidity test device
c2.2 The instrument can measure the displacement of the needle tube with a reading accuracy of c.01mm. C3 Test procedure
Magic cube push rod
C3.1 Place the needle tube on the rigidity test instrument (C2.1), and adjust the needle tube and the rigidity test instrument as follows: a) Make the span the value corresponding to the specification of the needle tube to be tested in Table 2; b) Make the end surface of the force pusher located at the center of the span; c) Keep the tube perpendicular to the two needle rack columns and the force push rod, and make the center line of the needle tube coincide with the center line of the needle rack: c3.2 Apply the force corresponding to the nominal specification of the needle tube in Table 2, and bend the needle tube downward at a rate of 1mm/min through the drag push rod.
C3.3 Measure and record the needle tube deflection at the force application point (C2.2), accurate to 0.01mmC4 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Wall type of the needle tube: normal wall, thin wall, ultra-thin wall;c) Measured deflection value (in mm, accurate to .01 mm) and judgment result, d) Test date.
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D1 Principle
GB18457—2001
(Appendix of the standard)
Test method for needle tube toughness
Fix one end of the needle tube, apply a force from the fixed point to the specified span of the needle tube, first bend it in a direction, then in the opposite direction by a specified angle, and repeat the bending for a specified number of times. D2 Instruments
D2.1 Fix the needle tube with tools and instruments.
D2.2 The instrument can apply a large enough force to the needle tube so that it can bend in the same plane at three angles, such as 25°, 20° and 15° in the forward and reverse directions.
D3 Test Procedures
D3.1 Fix the end of the needle tube firmly on the fixture (I)2.1). Adjust the specified span corresponding to the needle tube to be tested according to Table 3 and select the following bending angles: normal wall -
—-25°, thin wall
20 ultra-thin wall -
—15°
D3.2 Apply a large enough force at the specified span position, apply force in both directions 20 times at a frequency of 0.5Hz, and observe the fracture of the needle tube.
D4 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Type of the wall of the needle tube: normal, thin wall, ultra-thin wall; c) The result of the determination of the fracture of the needle tube during the test; d) Test date,
Appendix E
(Appendix of the standard)
Test method for corrosion resistance of needle tube
E1 Principle
After a part of the needle tube is immersed in the sodium chloride solution for a specified time, the immersed part is compared with the unimmersed part, and the corrosion marks are observed by oscillation.
E2 Instruments and reagents
E2.1 Sodium chloride solution
Use distilled water or deionized water that meets the requirements of Grade 3 water in GB6682-1992. Prepare c(NaCl) = 0.5 mol/L (analytical pure reagent drop liquid
E2.2 Select appropriate laboratory borosilicate glassware. 13-1
F3 Test procedure
GB 18457—2001
Put a needle tube into a glass container (F2.2) containing a sodium chloride solution (F2.1) at 23℃±2℃, so that half of the length of the needle tube is in the solution. Keep the solution and the needle tube at 23℃±2℃ for 7h±5min. Take the needle tube, rinse it with distilled water or high-ion water and dry it. Use normal vision or corrected vision to observe and compare the immersed and unimmersed parts to see if there are any corrosion marks caused by the device. E4 Test report
The test report shall contain at least the following contents:
a) Description and nominal specifications of the needle tube;
b) Type of needle tube wall: normal wall, thin wall, ultra-thin wall; c) Corrosion condition of the immersed part;
d) Test duration.
Appendix F
(Informative Appendix)
Stainless Steel Grades
The chemical composition of the stainless steel grades given in this standard and the comparison with other international standards and national standards are shown in Tables F1 to F3. a) The chemical composition of the stainless steel grades given in this standard is shown in Table F1 of Appendix F. b) The comparison of the stainless steel grades given in this standard with other international standards is shown in Table F2 of Appendix F. c) The comparison of the stainless steel grades given in this standard with other national standards is shown in Table F3 of Appendix F. KAONiKAca
GB 18457—2001
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C3.1 Place the needle tube on the rigid test instrument (C2.1), and adjust the needle tube and the rigid test instrument as follows: a) Make the span the value corresponding to the specification of the needle tube to be tested in Table 2; b) Make the end surface of the force pusher located at the center of the span; c) Keep the tube perpendicular to the two needle rack columns and the force push rod, and make the center line of the needle tube coincide with the center line of the needle rack: c3.2 Apply the force corresponding to the nominal specification of the needle tube in Table 2 at a rate of 1mm/min to bend the needle tube downward through the drag push rod.
C3.3 Measure and record the needle tube deflection at the force application point (C2.2), accurate to 0.01mmC4 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Wall type of the needle tube: normal wall, thin wall, ultra-thin wall;c) Measured deflection value (in mm, accurate to .01 mm) and judgment result, d) Test date.
iKAoNrKAca
D1 Principle
GB18457—2001
(Standard Appendix)
Test method for needle tube toughness
Fix one end of the needle tube, apply a force from the fixed point to the specified span of the needle tube, first bend it in a direction, then in the opposite direction by a specified angle, and repeat the bending for a specified number of times. D2 Instruments
D2.1 Fix the needle tube with tools and instruments.
D2.2 The instrument can apply a large enough force to the needle tube so that it can bend in the same plane at three angles, such as 25°, 20° and 15° in the forward and reverse directions.
D3 Test Procedures
D3.1 Fix the end of the needle tube firmly on the fixture (I)2.1). Adjust the specified span corresponding to the needle tube to be tested according to Table 3 and select the following bending angles: normal wall -
—-25°, thin wall
20 ultra-thin wall -
—15°
D3.2 Apply a large enough force at the specified span position, apply force in both directions 20 times at a frequency of 0.5Hz, and observe the fracture of the needle tube.
D4 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Type of the wall of the needle tube: normal, thin wall, ultra-thin wall; c) The result of the determination of the fracture of the needle tube during the test; d) Test date,
Appendix E
(Appendix of the standard)
Test method for corrosion resistance of needle tube
E1 Principle
After a part of the needle tube is immersed in the sodium chloride solution for a specified time, the immersed part is compared with the unimmersed part, and the corrosion marks are observed by oscillation.
E2 Instruments and reagents
E2.1 Sodium chloride solution
Use distilled water or deionized water that meets the requirements of Grade 3 water in GB6682-1992. Prepare c(NaCl) = 0.5 mol/L (analytical pure reagent drop liquid
E2.2 Select appropriate laboratory borosilicate glassware. 13-1
F3 Test procedure
GB 18457—2001
Put a needle tube into a glass container (F2.2) containing a sodium chloride solution (F2.1) at 23℃±2℃, so that half of the length of the needle tube is in the solution. Keep the solution and the needle tube at 23℃±2℃ for 7h±5min. Take the needle tube, rinse it with distilled water or high-ion water and dry it. Use normal vision or corrected vision to observe and compare the immersed and unimmersed parts to see if there are any corrosion marks caused by the device. E4 Test report
The test report shall contain at least the following contents:
a) Description and nominal specifications of the needle tube;
b) Type of needle tube wall: normal wall, thin wall, ultra-thin wall; c) Corrosion condition of the immersed part;
d) Test duration.
Appendix F
(Informative Appendix)
Stainless Steel Grades
The chemical composition of the stainless steel grades given in this standard and the comparison with other international standards and national standards are shown in Tables F1 to F3. a) The chemical composition of the stainless steel grades given in this standard is shown in Table F1 of Appendix F. b) The comparison of the stainless steel grades given in this standard with other international standards is shown in Table F2 of Appendix F. c) The comparison of the stainless steel grades given in this standard with other national standards is shown in Table F3 of Appendix F. KAONiKAca
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Magic Cube Push Rod
C3.1 Place the needle tube on the rigid test instrument (C2.1), and adjust the needle tube and the rigid test instrument as follows: a) Make the span the value corresponding to the specification of the needle tube to be tested in Table 2; b) Make the end surface of the force pusher located at the center of the span; c) Keep the tube perpendicular to the two needle rack columns and the force push rod, and make the center line of the needle tube coincide with the center line of the needle rack: c3.2 Apply the force corresponding to the nominal specification of the needle tube in Table 2 at a rate of 1mm/min to bend the needle tube downward through the drag push rod.
C3.3 Measure and record the needle tube deflection at the force application point (C2.2), accurate to 0.01mmC4 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Wall type of the needle tube: normal wall, thin wall, ultra-thin wall;c) Measured deflection value (in mm, accurate to .01 mm) and judgment result, d) Test date.
iKAoNrKAca
D1 Principle
GB18457—2001
(Standard Appendix)
Test method for needle tube toughness
Fix one end of the needle tube, apply a force from the fixed point to the specified span of the needle tube, first bend it in a direction, then in the opposite direction by a specified angle, and repeat the bending for a specified number of times. D2 Instruments
D2.1 Fix the needle tube with tools and instruments.
D2.2 The instrument can apply a large enough force to the needle tube so that it can bend in the same plane at three angles, such as 25°, 20° and 15° in the forward and reverse directions.
D3 Test Procedures
D3.1 Fix the end of the needle tube firmly on the fixture (I)2.1). Adjust the specified span corresponding to the needle tube to be tested according to Table 3 and select the following bending angles: normal wall -
—-25°, thin wall
20 ultra-thin wall -
—15°
D3.2 Apply a large enough force at the specified span position, apply force in both directions 20 times at a frequency of 0.5Hz, and observe the fracture of the needle tube.
D4 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Type of the wall of the needle tube: normal, thin wall, ultra-thin wall; c) The result of the determination of the fracture of the needle tube during the test; d) Test date,
Appendix E
(Appendix of the standard)
Test method for corrosion resistance of needle tube
E1 Principle
After a part of the needle tube is immersed in the sodium chloride solution for a specified time, the immersed part is compared with the unimmersed part, and the corrosion marks are observed by oscillation.
E2 Instruments and reagents
E2.1 Sodium chloride solution
Use distilled water or deionized water that meets the requirements of Grade 3 water in GB6682-1992. Prepare c(NaCl) = 0.5 mol/L (analytical pure reagent drop liquid
E2.2 Select appropriate laboratory borosilicate glassware. 13-1
F3 Test procedure
GB 18457—2001
Put a needle tube into a glass container (F2.2) containing a sodium chloride solution (F2.1) at 23℃±2℃, so that half of the length of the needle tube is in the solution. Keep the solution and the needle tube at 23℃±2℃ for 7h±5min. Take the needle tube, rinse it with distilled water or high-ion water and dry it. Use normal vision or corrected vision to observe and compare the immersed and unimmersed parts to see if there are any corrosion marks caused by the device. E4 Test report
The test report shall contain at least the following contents:
a) Description and nominal specifications of the needle tube;
b) Type of needle tube wall: normal wall, thin wall, ultra-thin wall; c) Corrosion condition of the immersed part;
d) Test duration.
Appendix F
(Informative Appendix)
Stainless Steel Grades
The chemical composition of the stainless steel grades given in this standard and the comparison with other international standards and national standards are shown in Tables F1 to F3. a) The chemical composition of the stainless steel grades given in this standard is shown in Table F1 of Appendix F. b) The comparison of the stainless steel grades given in this standard with other international standards is shown in Table F2 of Appendix F. c) The comparison of the stainless steel grades given in this standard with other national standards is shown in Table F3 of Appendix F. KAONiKAca
GB 18457—2001
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—--25°, thin wall
20, ultra-thin wall -
—15°
D3.2 Apply a sufficiently large force at the specified span position, at a frequency of 0.5Hz, apply force in both directions 20 times, and observe the breakage of the needle tube.
D4 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Type of the wall of the needle tube: normal, thin wall, ultra-thin wall; c) The result of the determination of the fracture of the needle tube during the test; d) Test date,
Appendix E
(Appendix of the standard)
Test method for corrosion resistance of needle tube
E1 Principle
After a part of the needle tube is immersed in the sodium chloride solution for a specified time, the immersed part is compared with the unimmersed part, and the corrosion marks are observed by oscillation.
E2 Instruments and reagents
E2.1 Sodium chloride solution
Use distilled water or deionized water that meets the requirements of Grade 3 water in GB6682-1992. Prepare c(NaCl) = 0.5 mol/L (analytical pure reagent drop liquid
E2.2 Select appropriate laboratory borosilicate glassware. 13-1
F3 Test procedure
GB 18457—2001
Put a needle tube into a glass container (F2.2) containing a sodium chloride solution (F2.1) at 23℃±2℃, so that half of the length of the needle tube is in the solution. Keep the solution and the needle tube at 23℃±2℃ for 7h±5min. Take the needle tube, rinse it with distilled water or high-ion water and dry it. Use normal vision or corrected vision to observe and compare the immersed and unimmersed parts to see if there are any corrosion marks caused by the device. E4 Test report
The test report shall contain at least the following contents:
a) Description and nominal specifications of the needle tube;
b) Type of needle tube wall: normal wall, thin wall, ultra-thin wall; c) Corrosion condition of the immersed part;
d) Test duration.
Appendix F
(Informative Appendix)
Stainless Steel Grades
The chemical composition of the stainless steel grades given in this standard and the comparison with other international standards and national standards are shown in Tables F1 to F3. a) The chemical composition of the stainless steel grades given in this standard is shown in Table F1 of Appendix F. b) The comparison of the stainless steel grades given in this standard with other international standards is shown in Table F2 of Appendix F. c) The comparison of the stainless steel grades given in this standard with other national standards is shown in Table F3 of Appendix F. KAONiKAca
GB 18457—2001
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166*01egl HL/OS!1) Adjust the specified span corresponding to the needle tube to be tested according to Table 3 and select the following bending angles: normal wall -
—--25°, thin wall
20, ultra-thin wall -
—15°
D3.2 Apply a sufficiently large force at the specified span position, at a frequency of 0.5Hz, apply force in both directions 20 times, and observe the breakage of the needle tube.
D4 Test report
The test report shall contain at least the following contents:
a) Specification and description of the needle tube;
b) Type of the wall of the needle tube: normal, thin wall, ultra-thin wall; c) The result of the determination of the fracture of the needle tube during the test; d) Test date,
Appendix E
(Appendix of the standard)
Test method for corrosion resistance of needle tube
E1 Principle
After a part of the needle tube is immersed in the sodium chloride solution for a specified time, the immersed part is compared with the unimmersed part, and the corrosion marks are observed by oscillation.
E2 Instruments and reagents
E2.1 Sodium chloride solution
Use distilled water or deionized water that meets the requirements of Grade 3 water in GB6682-1992. Prepare c(NaCl) = 0.5 mol/L (analytical pure reagent drop liquid
E2.2 Select appropriate laboratory borosilicate glassware. 13-1
F3 Test procedure
GB 18457—2001
Put a needle tube into a glass container (F2.2) containing a sodium chloride solution (F2.1) at 23℃±2℃, so that half of the length of the needle tube is in the solution. Keep the solution and the needle tube at 23℃±2℃ for 7h±5min. Take the needle tube, rinse it with distilled water or high-ion water and dry it. Use normal vision or corrected vision to observe and compare the immersed and unimmersed parts to see if there are any corrosion marks caused by the device. E4 Test report
The test report shall contain at least the following contents:
a) Description and nominal specifications of the needle tube;
b) Type of needle tube wall: normal wall, thin wall, ultra-thin wall; c) Corrosion condition of the immersed part;
d) Test duration.
Appendix F
(Informative Appendix)
Stainless Steel Grades
The chemical composition of the stainless steel grades given in this standard and the comparison with other international standards and national standards are shown in Tables F1 to F3. a) The chemical composition of the stainless steel grades given in this standard is shown in Table F1 of Appendix F. b) The comparison of the stainless steel grades given in this standard with other international standards is shown in Table F2 of Appendix F. c) The comparison of the stainless steel grades given in this standard with other national standards is shown in Table F3 of Appendix F. KAONiKAca
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