This standard specifies the type classification, size, marking, requirements, test methods, marking and packaging of aluminum-plastic composite covers for infusion bottles described in GB 2639-90. GB 5197.2-1996 Glass infusion bottle covers Part 2: Aluminum-plastic composite covers GB5197.2-1996 Standard download decompression password: www.bzxz.net

GB 5197. 2
Foreword
This standard is the first revised version of GB5197-85 "Glass infusion bottle aluminum cover standard equivalent to IS08536-7: 1992 Medical infusion equipment 10985: 1992 "Infusion bottle and injection bottle aluminum plastic combination bottle cover - Part 7: Aluminum plastic combination infusion bottle cover" and ISO-Requirements and test methods".
GB5197 glass infusion bottle cover includes the following two parts: GB5197.1 Glass infusion bottle cover Part 1: Lead cover; GB5197.2 Glass infusion bottle cover Part 2: Aluminum plastic combination cover. GB5197-85 is replaced by GB5197.1-1996, and the content of this standard is the new content of this revision. Appendix A of this standard is the appendix of the standard,
The appendix of this standard is the appendix of the prompt.
This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of Shandong Pharmaceutical Packaging Materials and Container Product Quality Inspection Center of the State Drug Administration. The main drafting units of this standard are Shandong Pharmaceutical Packaging Materials and Container Product Quality Inspection Center of the State Drug Administration and Shanghai Jiuan Packaging Industry Co., Ltd.
Who participated in the drafting of this standard: Shijia Nonferrous Metal Processing Factory, Shandong Weihai Lvming Beverage Packaging Company. The main drafters of this standard: Wu Ping, Zhang Liqing, Cai Hong, Yan Wei, Zhou Jianfeng, 161
GB 5197- 2-1996
ISO Foreword
ISO (International Organization for Standardization) is a world federation composed of national standards bodies (ISO member bodies). The work of formulating international standards is usually done by technical committees. If each member body is interested in a project established by a technical committee, it has the right to participate in the work of the committee. International organizations (official or non-official) that maintain ties with ISO may also participate in the relevant work. In terms of engineering technology standardization, IS maintains a close cooperative relationship with the International Electrotechnical Commission (IEC). The draft international standard adopted by the technical committee is submitted to each member group for voting. It must obtain the consent of at least 75 member groups participating in the voting before it can be officially released as an international standard. International Standard IS085367 was formulated by the Technical Committee of the International Organization for Standardization, Medical Blood Transfusion, Infusion and Syringes, IS0/TC76. The general title of IS08536 is: Medical Infusion Equipment, including the following parts: Part 1: Glass Infusion Bottle; Part 2: Infusion Bottle Stopper; Part 3: Aluminum Cap of Infusion Bottle: Part 1: Disposable Infusion Set; Part 5: Burette Infusion Set; Part 6: Freeze-dried Bottle Stopper of Infusion Bottle: Part 7: Aluminum-plastic Composite Infusion Bottle Cap.
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This standard specifies the type classification, size, marking, requirements, test methods, marking, packaging, and reference standards of the aluminum-plastic composite cover for infusion bottles (hereinafter referred to as "bottle cover") described in (B263990). The following standards contain provisions that constitute or become provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest versions of the following standards GB228·-87 Metal drawing test method
General tolerance of linear dimensions
GB/T 1804 92
GR2639-90 Glass infusion bottles
Batch inspection counting sampling process and sampling table (suitable for inspection of continuous batches) GB 2828---87
G32829-87 Periodic inspection counting sampling procedure and sampling table (applicable to the inspection of the stability of the butyl production process) YY 0169-1-94
3 Type classification
Butyl rubber infusion bottle stopper
The cap is divided into the following types:
ZB type: composed of aluminum cap with center tie and plastic parts; Z) type: composed of aluminum cap with tear-off tab and plastic parts. 4 Dimensions and tolerances
Various types of caps (fan-shaped, ring-shaped or other shapes) should comply with the dimensions specified in Figure 1 and Table 1. Note: The configuration of the bottle cap in Figure 1 is only Hong reference number. Approved by the State Administration of Technical Supervision on December 2, 1996 and implemented on July 1, 1997
GB 5197. 2
1- Period oblique piece; 2- Part tS- Marking
Figure 1 Bottle cap structure
Table 1 Bottle cap size
ZD type
1) t2 Should be determined by negotiation between the supply and demand parties, and should not exceed the nominal value by ±0.25mm. Only the minimum limit value is given in the table, and the tolerance is not specified. 2) The aperture after removing the material.
3) e Determined by the supply and demand parties, should not exceed the public limit value.
1) h: Should be determined by negotiation between the two parties, and should not exceed the nominal value by ±0.4mm. Only the limited value is given in the table. The tolerance is not specified. 4.2 Tolerance
Bottle caps without tolerances shall comply with the m-level regulations in GB/TT804. 5. Marking
The marking consists of "bottle cap", this standard number, type letter and nominal size. Example: In accordance with this standard, the nominal eight-inch 32, ZD type lead-plastic combination bottle cap is marked as bottle cap GB5197.2-ZD32
6. Requirements
Mechanical properties of aluminum parts
The mechanical properties of aluminum parts shall comply with the requirements specified in the three categories A, B and C in Table 2. Note 2: The appendix lists the chemical composition of commonly used aluminum alloys. Table 2 Mechanical properties of aluminum parts
Aluminum alloy 1)
Late annealing or addition AlFeSi
AlFesi
AlMnCu
1) Other aluminum alloys may also be selected if they meet the mechanical properties specified in this standard. 16
5
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Tensile Strength
100~150
1·10---180
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Elongation
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GB 5197.2—1996
6.2 Appearance Quality
Bottle caps should be clean, without residual lubricant, burrs, damage and injection molding flash, and plastic parts should be fully combined with aluminum parts. 6.3 Convex
The convex edge of the lead part of the bottle cap should not be greater than 3%.
6.4 Opening force
6.4.1 When tested according to Appendix A, the maximum force required to remove plastic parts and tear off the ZD-type aluminum parts shall comply with the provisions of Table 3 Table 3 Removal force and tearing force
Nominal size
Plastic parts removal
Tear off
6.4.2 The minimum force required to remove plastic parts and tear off the ZD-type aluminum parts shall comply with the value agreed upon by the supplier and the buyer. 6.5 Matching
After the process specified in Article 75.1, the bottle cap should fit well. 6.6 Strength
After the process specified in Articles 75..1 and 7.5.2, the bottle cap should not break or deform abnormally 6.7 Steam sterilization resistance
After the process specified in Article 7.5.2, the plastic parts should not be deformed or discolored, and the surface of the lead parts should not have any obvious changes. Plastic parts should also be able to withstand a steam sterilization temperature of 130°C for a short time (maximum 5 minutes) without deformation or discoloration. Note 3: Ordinary lead alloys tend to produce marks when sterilized in a steam sterilizer. 6.8 Opening quality
When the bottle cap is subjected to the lifting force test, after removing the plastic part (opening the bottle cap), the opening on the lead part should not be damaged. 6.9 Coating firmness
Lead parts with coatings on the outer surface should not show any signs of coating wear after the test. 6.10 Process requirements wwW.bzxz.Net
The assembly of lead parts and plastic parts should be carried out in a clean state, and ensure that the bottle after maintenance is not contaminated. 7 Test method
7.1 Mechanical properties
The mechanical properties (tensile strength and elongation) of aluminum parts should be in accordance with the provisions of GB228. Note 4: Bottle manufacturers can accept goods based on the mechanical properties test and chemical composition analysis reports issued by the material supplier. 7.2 Appearance quality
Visual inspection.
7.3 Dimensions
Inner diameter is inspected by limit gauge. Other dimensions are inspected by general measuring tools such as vernier scale, height gauge and micrometer: 7.4 Concave edge
The edge defect of the aluminum part is expressed as a percentage and calculated according to formula (1): hmrin
haroin
Where hanex
The maximum height of the outer side of the aluminum part of the bottle cap:
The minimum height of the outer side of the lead part of the bottle cap.
GB5197.2.-1996
Note: The figure is enlarged to illustrate the outer edge and minimum height. Figure 2. Explanation of the flange of the lead part of the bottle cap
7.5 Compatibility, strength, and resistance to sterilization
7.5.1 Capping process: Fill the glass infusion bottle that complies with GB2639 with water to the nominal capacity, cover it with a bottle stopper that complies with YY0169., add 1: bottle cap, and seal it with a sealing device
7.5.2 Steam sterilization process||tt ||Saturated steam treatment:
Heating time 30min:
Maintaining time
121±21
30min including I30℃ 25min)
Cooling time 30min down to 60℃
7.6 Coating strength
For aluminum parts with coating on the surface, after 7.5.2 and removing plastic parts, soak them in 80% (V/) alcohol aqueous solution for 30min and wipe the surface with degreasing.
8 Marking and packaging
8.1 The following marks should be clearly marked on the bottle cap packaging: a) manufacturer name:
b) product mark;
c) production number or date;
d) quantity
8.2 The packaging should ensure that the performance of the bottle cap is not adversely affected during transportation and storage and prevent any contamination. The inner packaging should be a plastic bag. The outer packaging should be a carton or paper barrel that can withstand standard transportation conditions. 166
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A1 Equipment
GB 5197.2-..1996
Appendix A
(Standard Appendix)
Opening force test method
Tension/positive testing machine with special accessories as shown in Figure A/near, driving speed r=100 mm/rmin, range ± 100 VA2
Plastic removal force
A2.1 As shown in Figure A1, clamp the bottle cap on the special clamp and apply force to remove the plastic part. Add force direction
Figure A1 Material removal test tube
Table A1 Rod size
Nominal ruler
A2.2 Record the general manpower value required to remove the plastic parts A3 Tear-off force
As shown in Figure A2. Tear off the exposed hook and hang the nail, and use the tension and compression testing machine to self-apply force according to the direction shown in Figure A2 to tear off the aluminum parts. 137
Nominal size
GB 5197.21996
Force direction
Tear-off force test tube
Table A2 Mandrel size
Appendix B
(Instructive appendix)
Inspection regulations and testing
Product inspection is divided into factory inspection and type inspection. Factory inspection
B2.1 Factory inspection shall be carried out in accordance with GI32828. The inspection items, non-conforming classification, acceptable quality level (AQL) and inspection level (IL) are shown in Table B1.
Inspection items
Appearance quality
Opening quality
Opening force
Plastic parts removal force
Tear off
Both marks and marks
Unqualified classification
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Clear iron purity
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B2.2 Group batches with the same specifications, classes and production units. B3 Type inspection
B3.1 Type inspection should be carried out in the following cases: a) When a new product is put into production or an old product is converted: GB 5197.2＇
b) When there is a major change in design, process or material; c) Once every six months in normal production:
d) When the production is stopped for more than half a year
c) When the national quality supervision agency proposes a requirement for type inspection 1996
H3.2 Type inspection adopts the provisions of GB2829. The inspection items, unqualified classification, unqualified quality level (RQ.) and discrimination level (DL) are as follows:
Inspection items
Mechanical properties
External quality
Opening
Plastic parts force removal
Compatibility
Steam and fire resistance
Opening quality
Internal degree
Unqualified classification
GB 5197.2:-1996
Appendix C
(Indicative Appendix)
Examples of Chemical Compositions of Aluminum Alloys
Examples of chemical composition ranges of aluminum alloys are given in Table C1, expressed in terms of weight percentage. Table C1 Chemical Composition Examples
Other elements, single-
trace 5
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Content.%(m/m）
0. 05~~ 0. 20
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Force direction
Tear sheet tearing force test device
Table A2 Mandrel size
Appendix B
(Suggested appendix)
Inspection regulations
Product inspection is divided into factory inspection and type inspection. Factory inspection
B2.1 Factory inspection is carried out in accordance with GI32828. The inspection items, non-conforming classification, acceptable quality level-half (AQL) and inspection level (IL) are shown in Table B1.
Inspection items
Appearance quality
Opening quality
Opening force
Plastic parts removal force
Tear off
Tear off
Trace 5
Unqualified classification
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Other lotus jaws
Clear other iron
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B2.2 Group batches with the same specifications, classes, and production. B3 Type inspection
B3.1 "Type inspection should be carried out in the following cases: a) When new products are put into production or old products are converted: GB 5197.2＇
b) When there is a major change in design, process or material; c) Once every six months in normal production:
d) When the production is stopped for more than half a year
c) When the national quality supervision agency proposes a requirement for type inspection 1996
H3.2 Type inspection adopts the provisions of GB2829. The inspection items, unqualified classification, unqualified quality level (RQ.) and discrimination level (DL) are as follows:
Inspection items
Mechanical properties
External quality
Opening
Plastic parts force removal
Compatibility
Steam and fire resistance
Opening quality
Internal degree
Unqualified classification
GB 5197.2:-1996
Appendix C
(Indicative Appendix)
Examples of Chemical Compositions of Aluminum Alloys
Examples of chemical composition ranges of aluminum alloys are given in Table C1, expressed in terms of weight percentage. Table C1 Chemical Composition Examples
Other elements, single-
trace 5
17bzw.cn crispy lotus
17jizw.com crispy bear throw
Content.%(m/m）
0. 05~~ 0. 20
0. 101. 5
kind of demon boiled lotus root color
kind of iron succinct crane
1 collection Ying 6021996
Force direction
Tear sheet tearing force test device
Table A2 Mandrel size
Appendix B
(Suggested appendix)
Inspection regulations
Product inspection is divided into factory inspection and type inspection. Factory inspection
B2.1 Factory inspection is carried out in accordance with GI32828. The inspection items, non-conforming classification, acceptable quality level-half (AQL) and inspection level (IL) are shown in Table B1.
Inspection items
Appearance quality
Opening quality
Opening force
Plastic parts removal force
Tear off
Tear off
Trace 5
Unqualified classification
17bzw.cn Brittle wall lotus
17jzw.com Brittle rate
Other lotus jaws
Clear other iron
1 Ying60
B2.2 Group batches with the same specifications, classes, and production. B3 Type inspection
B3.1 "Type inspection should be carried out in the following cases: a) When new products are put into production or old products are converted: GB 5197.2＇
b) When there is a major change in design, process or material; c) Once every six months in normal production:
d) When the production is stopped for more than half a year
c) When the national quality supervision agency proposes a requirement for type inspection 1996
H3.2 Type inspection adopts the provisions of GB2829. The inspection items, unqualified classification, unqualified quality level (RQ.) and discrimination level (DL) are as follows:
Inspection items
Mechanical properties
External quality
Opening
Plastic parts force removal
Compatibility
Steam and fire resistance
Opening quality
Internal degree
Unqualified classification
GB 5197.2:-1996
Appendix C
(Indicative Appendix)
Examples of Chemical Compositions of Aluminum Alloys
Examples of chemical composition ranges of aluminum alloys are given in Table C1, expressed in terms of weight percentage. Table C1 Chemical Composition Examples
Other elements, single-
trace 5
17bzw.cn crispy lotus
17jizw.com crispy bear throw
Content.%(m/m）
0. 05~~ 0. 20
0. 101. 5
kind of demon boiled lotus root color
kind of iron succinct crane
1 collection Ying 60
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