Some standard content:
GB 2637—1995
This standard is the second revised version of GB 2637-81. The test method for water resistance of inner surface of glass containers in this standard refers to GB12416.1-90 Test method and classification of water resistance of medicinal glass containers”, which is equivalent to 1S04802-1:1988. The following chapters have been changed in this version: -1 (applicable to easy-to-break wires; the provisions on wire classification and grading have been cancelled); -3.2 (the requirement for grading wire outer diameter within the limit deviation has been added); -3.3 (product marking has been added); -4.4.2 (the requirement that the cross section of the wire should be flat after breaking has been added); -5.2.2 (the maximum value of AQL in Table 3 has been increased from 10.0 to 6.5); -6.1.3 (the test method for wire breaking force has been supplemented); -7.2.1 (the requirement for sealing wire inner packaging with heat shrink film has been added); -7.2.4 (the provisions on the storage period of wire packaging have been added). In order to actively implement the policy of adopting international standards and to achieve international standards as soon as possible, this standard includes the specifications and dimensions of two international standards, IS091871:1991 "Medical Injection Equipment: Ampoules for Injection" and IS091872:1993 "Medical Injection Equipment---Easy-to-fold Ampoules", in Appendix A (Suggested Appendix). According to the special needs of users, the alkali resistance test method of ampoule is included in Appendix B (Suggested Appendix) for reference. Since ampoule is a special packaging product that directly contacts drugs, its quality directly affects the safety and effectiveness of human medication, this standard is a mandatory standard. The level of this standard is at the domestic advanced level. From the date of entry into force, this standard will replace GB2637-90 at the same time. This standard is proposed by the State Drug Administration: This standard is drafted by the National Glass and Porcelain Product Quality Supervision and Inspection Center. The responsible drafting unit of this standard is Shanghai Glass Factory. The main drafters of this standard are Cui Hongling, Lai Dezhen and Chen Lijuan. This standard was first issued in 1981, revised for the first time in 1990, and revised for the second time in 1995. 1 Scope
National Standard of the People's Republic of China
Ampoule
G1 26371995
Replaces GR 2637SO
This standard specifies the specifications and dimensions of flexible parts. Product marking, requirements, sampling, test methods, marking, packaging. This standard is applicable to disposable color ring and dot-marked flexible parts. 2 Referenced Standards
The provisions contained in the following standards constitute the text of this standard through reference in this standard. When this standard was published, the versions shown were all valid. All standards will be revised. All parties using this standard should explore the possibility of using the latest version of the following standards. GB191-90 Packaging and transportation graphic mark
(9132828-87 Batch inspection counting sampling procedure to change sampling table (applicable to continuous batch inspection) GB654386 Corrugated paper box
GB 12414-1995 Medicinal glass tube
GB12415-90 Medicinal glass container internal stress test method GB12416.1-90 Medicinal glass container water resistance test method and classification 3 Specifications and product markings
3.1 The specification of the ampoule shall comply with the provisions of Figure 1, Figure 2 and Table 1. Food Forum Exchange Information, WWPOODMATE.AET State Technical Supervision Bureau 1995-12-26 approved 1996-08-01 implementation
Counterpoint
Figure 1 Color ring easy to remove An Yan
GB 26371995
Wang: The rest of the dimensions are shown in Figure 1.
Figure 2 Dot notch Easy-folding and safe part
3.2 The outer diameter of the wire is within the limited deviation and is required to be divided into at least two gears. 3.3 Product marking
The specification is 2 mL, made of colorless glass (cl), and the color ring easy-folding and safe marking example that meets the requirements of this national standard is: Anzhen GB 2637-chr-2-cl
The example of the marking of the dot-marked and foldable part of the 2-inL bottle made of brown glass (br) in accordance with the requirements of this national standard is: GB2637-0PC-2-br
4 Requirements
4.1 Material
4.1.1 It should be made of colorless or full-color glass tube that meets the relevant provisions of GB12414. 4.1.2 If the chemical red and red of the glass material changes, the manufacturer should notify the user in advance. 4.2 Water resistance of the inner surface
The water resistance of the inner surface of the bottle should meet the requirements of HCl level in GB12416.1. Note: Users can use alkali resistance as a reference according to special needs. The test method is shown in Appendix B. 4.3 Annealing quality
The optical path difference caused by the maximum water stress after annealing should not exceed 40nm per millimeter of glass thickness. 4.4 Fracture force
4.4.1 The fracture force of the steel sheet should meet the value specified in Table 2. Food Crystal Forum Exchange Information WWW.FOODMATE.NET GB2637-1995
19℃ 1000
Jo=!
Food Theory
After the steel sheet is broken, the cross section should be flat.
4.5 Appearance quality
4.5.1 Cracks
There should be no cracks in any part,
4.5.2 Bubble line
GB 26371995
Table 2 Breaking force
Stent original distance
36=(18·f18)
60=(22·+38)
There should be no bubble line with a width greater than 0.10 mm 4.5.3 Stones and nodules
There should be no stones with a diameter greater than 0.50 mm, and no nodules with a diameter less than 1.00 mm Minimum value
Breaking force, N
Maximum value
4.5.4 The color dot of the notch should be marked at the center above the notch, and the deviation from the center line should not exceed 21.0 mm 5 SamplingwwW.bzxz.Net
5.1 Batch
The manufacturer takes the monthly production basis, the shift volume or the machine output as a batch; while the household takes the one-time delivery volume as a batch. 5.2 Sampling strategy
5.2.1 Sampling according to the plan specified in GB2828
5.2.2 Inspection items, inspection levels and qualified quality levels shall comply with the provisions of Table 3. Table 3 Inspection items, inspection levels and qualified quality levels Test number
Test item serial number
Inspection item
Body outer diameter
Wire outer diameter
Bulb outer diameter
Lock outer diameter
Bottom diameter
Circular runout
Terms of this standard
Inspection level-TT
Qualified quality level AQ1
Test group serial number
Test item serial number
G 2637—1995
Table 3 (end)
Inspection items
Bubble line
Fire quality
Breaking force
Clause of this standard
Inspection level IL
Qualified quality water half AQL
5.2.3 The water resistance of the inner surface of each batch of products shall be sampled and tested in accordance with the provisions of GB312416.1, and the results shall comply with the provisions of 4.2. 5.3 Judgment rules
5.3. 1 When the manufacturer receives the inspection in 5.2, all products shall be qualified before they can leave the factory. 5.3.2 When the user accepts the product, if any of them fail to meet the requirements of 5.2, the user and the manufacturer shall conduct a joint inspection on the unqualified items, and the batch of products shall be judged based on the inspection results.
6 Test methods
6.1 Physical and chemical properties
6.1.1 Water resistance of inner surface
Test according to the provisions of (B12416.1. 6.1.2 Annealing quality
Test according to the provisions of GE12415.
6.1.3 Breaking force
6.1.3.1 Original
Determine the force required to separate the neck and body of the ampoule. 6.1.3.2 Instrument
A ampoule breaking force instrument with an accuracy of 0.1N shall have the following characteristics: Test speed: 10mtm/min:
- Smallest measuring range: 0 to 200 N.
Testing device must be Figure 3.
Food Forum Exchange Information WWW.FOODMATE.NET25
6.1. 3.3 Test steps
GB 26371995
Figure 3 Test device for the fracture force of the test piece
Set a distance between the two metal brackets (as shown in Figure 3 and in accordance with the provisions of Table 2) so that a force can be applied between the metal brackets at an angle of 90° to the central axis of the test piece. Apply force with the fracture force meter until the test piece gradually breaks, and record the fracture force value. Note: When notching the fracture force of the test piece at the test point, the force-applying component in the device should be positioned between the notches (notches facing downward). Otherwise, the fracture force will increase. 6.1.3.4 Test report
The test report should include the following:
Name of the test instrument;
Test gauge and quantity;
Test results;
Test unit, month, tester, etc. 6.2 Specifications and dimensions
6.2.1 External diameter and height
Measured with a vernier caliper with an accuracy of 0.01 mm. 6.2.2 Thickness
Measured with a thickness gauge with an accuracy of 0.01 mm. 6.2.3 Roundness and bottom
Measured with an instrument with an accuracy of 0.01 mm. 6.3 Appearance quality
Mainly tested by day force, supplemented by a 10x reading magnifying glass when necessary
Food Forum Exchange Information
7 Marking and packaging
7.1 Marking
GB 2637
7.1.1 The packaging marking shall comply with the relevant provisions of GB191. 7.1.2 The packaging should be accompanied by a certificate or label, and indicate the following: 1. Product name, production license number;
2. Factory name, address, trademark:
3. Product mark, quantity;
4. Production date, name or code of the inspector. 7.2 Packaging
7.2.1 The inner packaging of the product should be made of materials that do not peel off fibrous particles and sealed with heat shrink film. 7.2.2 The outer packaging of the product should be a five-layer double-sided carton, which should comply with the relevant provisions of GH6543. 7.2.3 The tools used to transport the packaged items should be clean, pollution-free, and have a canopy. The packaged items should be handled with care during loading and unloading. 7.2.4 The packaged items should be stored in a clean, ventilated, dry and pollution-free environment. The storage period should not exceed 12 months. Food Forum Exchange Information WWW.FOODMATE.NETGH 2637—1995
Appendix A
(Tyr's Appendix)
Specifications and breaking force of ampoules for medical injection equipment Figures A1, A2, A3 and Table A1 and Table A2 of this Appendix are extracted from the specifications and sizes of ampoules for injection.
IS09187-1:1991 Medical injection equipment-full mouth
Sealing point
Note: For other dimensions, see Figure 1.
Figure A1 B type
Curved neck cut wire ampoules
Round head seal
Figure A2 C type funnel πH ampoules
Note: For other dimensions, see Figure 1.
Graphics and data
Outer diameter
.± 0. 15
22 5 =
0. 25 5. 5
32 6 10.75 8. 5
Outer diameter of bubble
Outer diameter of wire
Outer diameter of surge\"National head
1 0. 13. 7±0. K
,
Basic level team basic limit
1) If it is necessary to reduce the diameter of the curved neck, for example, to reduce the grain, it should be negotiated by the manufacturer and the user. 2) The outer lightness of the funnel and the round head can also be any size larger than the extension line of the bottle body. 3) Only when the following restrictions are met, the tolerance is valid ≥+1 of the actual size 1.41 eccentric public office as the sealing point measurement
Specification size small
bottom to quota
size! ! Article test
255.±0. 5
116.510.5
Neck center radius
10 size
1. 25,±c 75
Food Forum Exchange Information WWW.FOODMATE.NET Body thickness
Neck thickness
0.7 ±0.15
GB2637—1995
Table A2 Breaking force
Standard distance
f-(+i)
36=(181183
60=(22+38)
Minimum value
Maximum value
Figure A4 and Table A3 in this appendix The specification dimensions of the dot-marked easy-to-break ampoule (OPC) and the requirements for the breaking force in Table A4 are extracted from ISO9187-2:1993 Dual medical injection equipment
Easy to break and be broken.
Figure A4 Typical example of dot-marked easy-to-break ampoule (OPC) Food Crystal Forum Exchange Information WWW.FOODMATE.NET Specifications
10 --30
B1 Reagent
GB2637-1995
Table A3 Dot notch easy to break An Yan (OPC) specification ruler color point diameter
Bottom to color point height
Nong A4 Breaking force
Standard distance
Minimum value
36-(18—18)
60-(22-38)
Appendix B
(Suggested Appendix)
An Shao Alkali Resistance Test Method
B1.1 Distilled water: must be freshly boiled and free of carbon dioxide. B1.2 Sodium oxychloride (GB629) analytical grade. 25
Neck wall thickness
0.7+0. 10
0. 71 0. 15
u. 8±. 15
Breaking force
Maximum value
B1.3<(VaOH)=0.1mo1/Land c(NaOII)=0.5mol/I, Sodium hydroxide standard solution: Weigh about 4 and 20g of sodium hydroxide respectively, put them into 1000mL container bottles, dilute to the mark with distilled water, shake well and calibrate. B1.4 c(NaO1I)=0.001mol/L sodium hydroxide solution: Use a pipette to accurately draw 10ml of the calibrated c(NaOFI)=(.1m/1. sodium hydroxide standard solution 1=1000ml. into a volumetric flask. Dilute to the mark with distilled water, and then add B1.5 (NaOH)=0.0075mol/L cyanamide solution: Accurately draw 15mL of the calibrated c(NaOH)=0.5rmol/1. sodium hydroxide standard solution into a 1000mL volumetric flask, and dilute to the mark with distilled water, and then add aboutNETGH 2637—1995
Appendix A
(Tyr's Appendix)
Specifications and breaking force of ampoules for medical injection equipment Figures A1, A2, A3 and Table A1 in this appendix are the specifications and dimensions of ampoules and the requirements for breaking force of ampoules for injection.
IS09187-1:1991 Medical injection equipment-full mouth
Sealing point
Note: For other dimensions, see Figure 1.
Figure A1 B type
Curved neck cut wire ampoules
Round head seal
Figure A2 C type funnel πH ampoules
Note: For other dimensions, see Figure 1.
Graphics and data
Outer diameter
.± 0. 15
22 5 =
0. 25 5. 5
32 6 10.75 8. 5
Outer diameter of bubble
Outer diameter of wire
Outer diameter of surge\"National head
1 0. 13. 7±0. K
,
Basic level team basic limit
1) If it is necessary to reduce the diameter of the curved neck, for example, to reduce the grain, it should be negotiated by the manufacturer and the user. 2) The outer lightness of the funnel and the round head can also be any size larger than the extension line of the bottle body. 3) Only when the following restrictions are met, the tolerance is valid ≥+1 of the actual size 1.41 eccentric public office as the sealing point measurement
Specification size small
bottom to quota
size! ! Article test
255.±0. 5
116.510.5
Neck center radius
10 size
1. 25,±c 75
Food Forum Exchange Information WWW.FOODMATE.NET Body thickness
Neck thickness
0.7 ±0.15
GB2637—1995
Table A2 Breaking force
Standard distance
f-(+i)
36=(181183
60=(22+38)
Minimum value
Maximum value
Figure A4 and Table A3 in this appendix The specification dimensions of the dot-marked easy-to-break ampoule (OPC) and the requirements for the breaking force in Table A4 are extracted from ISO9187-2:1993 Dual medical injection equipment
Easy to break and be broken.
Figure A4 Typical example of dot-marked easy-to-break ampoule (OPC) Food Crystal Forum Exchange Information WWW.FOODMATE.NET Specifications
10 --30
B1 Reagent
GB2637-1995
Table A3 Dot notch easy to break An Yan (OPC) specification ruler color point diameter
Bottom to color point height
Nong A4 Breaking force
Standard distance
Minimum value
36-(18—18)
60-(22-38)
Appendix B
(Suggested Appendix)
An Shao Alkali Resistance Test Method
B1.1 Distilled water: must be freshly boiled and free of carbon dioxide. B1.2 Sodium oxychloride (GB629) analytical grade. 25
Neck wall thickness
0.7+0. 10
0. 71 0. 15
u. 8±. 15
Breaking force
Maximum value
B1.3<(VaOH)=0.1mo1/Land c(NaOII)=0.5mol/I, Sodium hydroxide standard solution: Weigh about 4 and 20g of sodium hydroxide respectively, put them into 1000mL container bottles, dilute to the mark with distilled water, shake well and calibrate. B1.4 c(NaO1I)=0.001mol/L sodium hydroxide solution: Use a pipette to accurately draw 10ml of the calibrated c(NaOFI)=(.1m/1. sodium hydroxide standard solution 1=1000ml. into a volumetric flask. Dilute to the mark with distilled water, and then add B1.5 (NaOH)=0.0075mol/L cyanamide solution: Accurately draw 15mL of the calibrated c(NaOH)=0.5rmol/1. sodium hydroxide standard solution into a 1000mL volumetric flask, and dilute to the mark with distilled water, and then add aboutNETGH 2637—1995
Appendix A
(Tyr's Appendix)
Specifications and breaking force of ampoules for medical injection equipment Figures A1, A2, A3 and Table A1 in this appendix are the specifications and dimensions of ampoules and the requirements for breaking force of ampoules for injection.
IS09187-1:1991 Medical injection equipment-full mouth
Sealing point
Note: For other dimensions, see Figure 1.
Figure A1 B type
Curved neck cut wire ampoules
Round head seal
Figure A2 C type funnel πH ampoules
Note: For other dimensions, see Figure 1.
Graphics and data
Outer diameter
.± 0. 15
22 5 =
0. 25 5. 5
32 6 10.75 8. 5
Outer diameter of bubble
Outer diameter of wire
Outer diameter of surge\"National head
1 0. 13. 7±0. K
,
Basic level team basic limit
1) If it is necessary to reduce the diameter of the curved neck, for example, to reduce the grain, it should be negotiated by the manufacturer and the user. 2) The outer lightness of the funnel and the round head can also be any size larger than the extension line of the bottle body. 3) Only when the following restrictions are met, the tolerance is valid ≥+1 of the actual size 1.41 eccentric public office as the sealing point measurement
Specification size small
bottom to quota
size! ! Article test
255.±0. 5
116.510.5
Neck center radius
10 size
1. 25,±c 75
Food Forum Exchange Information WWW.FOODMATE.NET Body thickness
Neck thickness
0.7 ±0.15
GB2637—1995
Table A2 Breaking force
Standard distance
f-(+i)
36=(181183
60=(22+38)
Minimum value
Maximum value
Figure A4 and Table A3 in this appendix The specification dimensions of the dot-marked easy-to-break ampoule (OPC) and the requirements for the breaking force in Table A4 are extracted from ISO9187-2:1993 Dual medical injection equipment
Easy to break and be broken.
Figure A4 Typical example of dot-marked easy-to-break ampoule (OPC) Food Crystal Forum Exchange Information WWW.FOODMATE.NET Specifications
10 --30
B1 Reagent
GB2637-1995
Table A3 Dot notch easy to break An Yan (OPC) specification ruler color point diameter
Bottom to color point height
Nong A4 Breaking force
Standard distance
Minimum value
36-(18—18)
60-(22-38)
Appendix B
(Suggested Appendix)
An Shao Alkali Resistance Test Method
B1.1 Distilled water: must be freshly boiled and free of carbon dioxide. B1.2 Sodium oxychloride (GB629) analytical grade. 25
Neck wall thickness
0.7+0. 10
0. 71 0. 15
u. 8±. 15
Breaking force
Maximum value
B1.3<(VaOH)=0.1mo1/Land c(NaOII)=0.5mol/I, Sodium hydroxide standard solution: Weigh about 4 and 20g of sodium hydroxide respectively, put them into 1000mL container bottles, dilute to the mark with distilled water, shake well and calibrate. B1.4 c(NaO1I)=0.001mol/L sodium hydroxide solution: Use a pipette to accurately draw 10ml of the calibrated c(NaOFI)=(.1m/1. sodium hydroxide standard solution 1=1000ml. into a volumetric flask. Dilute to the mark with distilled water, and then add B1.5 (NaOH)=0.0075mol/L cyanamide solution: Accurately draw 15mL of the calibrated c(NaOH)=0.5rmol/1. sodium hydroxide standard solution into a 1000mL volumetric flask, and dilute to the mark with distilled water, and then add about
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