title>GB 2639-1990 Glass infusion bottle - GB 2639-1990 - Chinese standardNet - bzxz.net
Home > GB > GB 2639-1990 Glass infusion bottle
GB 2639-1990 Glass infusion bottle

Basic Information

Standard ID: GB 2639-1990

Standard Name: Glass infusion bottle

Chinese Name: 玻璃输液瓶

Standard category:National Standard (GB)

state:in force

Date of Release1990-07-01

Date of Implementation:1991-02-01

standard classification number

Standard ICS number:Medical and Health Technology>>Pharmaceutics>>11.120.20 Medical Materials

Standard Classification Number:Medicine, Health, Labor Protection>> Medicine, Health, Labor Protection Comprehensive>> C08 Marking, Packaging, Transportation, Storage

associated standards

alternative situation:Replaced GB 2639-1981; replaced by GB/T 2639-2008

Procurement status:≈DIN 58363-1984

Publication information

publishing house:China Standards Press

other information

Release date:1981-05-03

Review date:2004-10-14

Drafting unit:Nantong Glass Factory No.1

Focal point unit:China Light Industry Federation

Publishing department:State Bureau of Technical Supervision

competent authority:China Light Industry Federation

Introduction to standards:

This standard specifies the product classification, specifications, dimensions, technical requirements, test methods, inspection rules and marking, packaging, transportation and storage of glass infusion bottles. This standard applies to glass infusion bottles for injection. GB 2639-1990 Glass Infusion Bottles GB2639-1990 Standard Download Decompression Password: www.bzxz.net

Some standard content:

National Standard of the People's Republic of China
Glass infusion bottles
Subject content and scope of application
GB2639--90
Replaces GB2639-81
This standard specifies the product classification, specifications and dimensions, technical requirements, test methods, inspection rules and marking, packaging, transportation, storage of glass infusion bottles
This standard applies to glass infusion bottles containing injection liquid 2
Referenced standard
GR2828 Batch inspection counting sampling sequence and sampling table (applicable to continuous batches) (Inspection) B4546 Test method for internal pressure of glass bottles and jars GB4547 Test method for thermal shock resistance of glass bottles and jars GR8452 Test method for vertical axis deviation of glass containers GB12415 Test method for internal stress of medicinal glass containers GB12416.1 Test method and classification for water resistance of medicinal glass containers G1312416.2 Test method and classification for water resistance of glass particles at 121C 3 Product classification and classification
Products are divided into Type I and Type II according to the type of glass, and should be marked on the bottom of the bottle. 3. 1
Note: Type I glass is borate glass, Type II glass is calcified glass that has been treated with an internal surface treatment, and Type II glass is only suitable for glass infusion bottles used for drinking,
3.2 Product bottle types are divided into Type A, Type B Two types. 3.3 Products are divided into superior products, second-class products and qualified products according to quality grade. 4 Specifications and dimensions
4.1 The specifications and dimensions of type A bottles shall comply with the provisions of Figure 1 and Table 1. Approved by the State Bureau of Technical Supervision on July 17, 1990 128
Implementation on February 1, 1991
GB2639-90
Deep texture
For glass!
Note: ① The width of the engraved track of the numbers and markings is 0.6mm, and the outer protrusion is 0.3mm. 45
(2 The inverted semi-nominal penetration marking line shall be marked on one side of the nominal bulk density marking line and on the other side separated by 180°. Model number
Marking line capacity
Outer diameter of the bottle body
Basic size
Bottom connected
GB26399 0
Main specification dimensions
Limit difference
Neck quotient
Shoulder arc height
Bottle mouth outer diameter
Specification scale
Bottle body thickness
Superior products
Reference specification
Bottom upper arc
Note: Vertical axis deviation refers to the horizontal deviation from the center of the bottle mouth to the vertical line passing through the center of the bottle bottom. 4.2B type The size of the bottle shall conform to the requirements of Figure 2 and Table 2, 130
Inner diameter of bottle mouth
Vertical axis deviation
First-class product
Bottom arc
Bottle bottom thickness
Qualified product
GB2639—90
Point twist or wave
Broken plastic
Note: (1) The width of the number and mark is 0.8 mm, and the outer convexity is 0.4 mm. ②) The inverted semi-nominal capacity mark should be marked on the nominal capacity mark - side and the other side separated by 180 respectively. R0.
Marking line penetration
Shaft outer diameter
Basic size
Limit deviation
Bottom connection
Technical requirements
Neck height
GB2639-90
Main specification size
Limit deviation
Superior product, first-class product, qualified product
Bottle mouth outer diameter
Bottle body thickness
Said product
Bottom upper arc
Bottle mouth inner diameter
Vertical axis deviation
First-class product
Material The product is made of colorless glass, and the water-repellency level of the glass should meet the following requirements according to the glass type. 5.1
Type 1 glass: meets the requirements of level 1 in GB12416.2, Type II glass: meets the requirements of level 2 or level 3 in GR12416.2138
Bottle bottom thickness
Qualified products
Note: When the material changes, the user should be notified in advance. 5.2 Physical and chemical properties:
Should meet the requirements of Table 3.
1. Water resistance of glass container
2. Thermal stability
3. Resistance to thermal decay
(resistance to thermal shock)
4. Internal pressure
5. Internal stress
5.3 Appearance quality
5.3.1 Color: colorless and transparent
5.3.2 Glass filaments, flying wings and spikes
5.3.3 Bubbles
Surface bubbles and broken bubbles
GB2639—90
Superior products
Second-class products
Should meet the requirements of HC1 and HC2 in Table 2 of GB 12416. 1Qualified products
Fill the bottle with clean water to the nominal capacity mark and keep it at 121℃ for 30 minutes No rupture According to the provisions of GB4547, the bottle shall not rupture after being subjected to the following differential heat test 42
According to the provisions of GB 4546, the bottle shall not rupture after being subjected to the following internal pressure test 0.6 MPa
According to the provisions of GB12415, the true stress of the bottle must be less than or equal to 20nm/nm
Glass with an inner diameter greater than or equal to 5mm
Glass with an inner diameter less than 5mm and greater than or equal to 3mm≥500mLNot more than (pieces)
2500mL, not more than (pieces)
Glass with an inner diameter less than 3 mm and greater than or equal to 1 mm≤500mLNot more than (pieces)
2500mLNot more than (pieces)
Diameter on the bottle wall less than 1 tnm The density that can be visually observed shall not exceed (pieces/cm\)
Sealing surface of bottle mouth. 1 5.3.4 Stones
Diameter greater than or equal to 1 mm
Diameter less than 1 mm, without cracks around
≤500 ml No more than (pieces)
500 ml, no more than (pieces)
Diameter less than 0.5 mm, without cracks around
<0 mL No more than (pieces)
500 ml
No more than (pieces)
The total number of b and c does not exceed (pieces)
5.3.5 Cracks (surface point-shaped bumps are not considered cracks) 5.3.6 Seam line
30um/mm
30mm/mm
Light yellow or light green is allowed
Not allowed
Not allowed
Not allowed
Not allowed
Not allowed
Not allowed
Not allowed
The bottle mouth is measured from the inside with a maximum of 0.3mm
HOther parts are measured from the outside with a maximum of 0.5mm
5.3.7 Bottle mouth
Smooth rounded corners
GB 2639—90
The sealing surface of the bottle mouth and the inner diameter of the bottle mouth should be smooth and flat 5.3.8 The bottle body should be smooth and full
5.3.9 Stripes
Serious
5.3.10 Graduation lines, characters and marks are clearly visible 6 Test methods
6.1 Physical and chemical properties
6.1.1 Water resistance of glass containers: in accordance with the provisions of GB12416.1. Not allowed
Not allowedbzxz.net
Not allowed
6.1.2 Thermal stability: Fill the bottle to the nominal capacity mark and plug it with a rubber stopper. Press tightly with aluminum cover, place in autoclave and heat to 121℃ evenly within 15-20 minutes and keep warm for 30 minutes. Release to normal pressure, open cover slightly, cool naturally until the temperature in the autoclave is lower than the sum of the temperature difference index in the thermal shock resistance test and the room temperature, open cover, cool and take out, no cracks, 6.1.3 Thermal shock resistance: Test according to GI4547. 6.1.4 Internal pressure: Test according to GB4546, 6.7.5 Internal stress: Test according to GB12415. 6.2 Specifications
6.2. 1 Inner diameter, outer diameter, height: Measure with a vernier caliper with a graduation value of 0.02 mm and a vernier height gauge with a graduation value of 0.02 mm. 6.2.2 Thickness: measured with a thickness gauge with a graduation value of 0.05 mm or a vernier caliper with a graduation value of 1.02 mm 6.2.3 Vertical axis deviation: tested in accordance with the provisions of GB8452. 6.2.4 Capacity: tested in accordance with the provisions of Appendix A (Supplement). 6.3 Appearance quality
Mainly based on sensory inspection, supplemented by a vernier caliper or a 10x magnifying glass when necessary. 7 Inspection rules
7.1 Batch: A batch is based on daily output, shift output or monthly output of a machine or shift output. 7.2 Sampling plan: The supplier or the buyer can choose any one of the single, double or triple sampling plans specified in CB2828.
7.3 The qualified rate of water resistance of glass containers should be 100%. 7.4 The inspection level and qualified quality level of other items should comply with the provisions of Table 4. Table 4
Test items
Item number
Test item H
Thermal stability
Internal pressure
Internal stress
Anti-thermal decay
Technical requirements
Requirements
Testing party
Superior product
Lunge quality level
First-class product
Qualified product
Test item
Rijin No.
Test item
Inner diameter of bottle mouth
Full Height, outer diameter of bottle mouth, outer diameter of bottle body
Vertical axis gain
Bottle body thickness
Marking line measurement
Glass wire, flying wing spikes
Surface air pool and broken bubbles, heavy cracks, bottle mouth air filter, stones, light cracks, bottle body
Color, seam line, stripe scale line, characters, marking GB2639:90
Continued Table 4
Technical requirements
Terms
Note: Cracks on the sealing surface of the bottle mouth are heavy cracks, and cracks in other parts are light cracks. 7.5 Judgment rules
Test method
Legal terms
Superior products
Qualified quality level
First-class products
Qualified products
When the consignee accepts and accepts, if any technical indicator fails to meet the requirements, the consignee and the manufacturer will jointly inspect the unqualified item and determine whether the level of the batch of products is qualified or unqualified based on the joint inspection results. 8 Marking, packaging, transportation, storage
8.1 Marking; Each packaged product shall be accompanied by a certificate or label. Indicate the production unit, product name, specification model, quantity, quality grade, manufacturer, inspection and packaging name or code, and the words "Glass products, handle with care" shall be on the outer packaging. 8.2 Packaging: The packaging material shall ensure that the product is clean, safe and firm, and the packaging quantity shall meet the transportation requirements. 8.3 Transportation: Severe vibration should be prevented during transportation, and it should be handled with care during loading and unloading. 8.4 Purchase and storage: The storage place should be clean, dry and safe. 135
GB 2639-90
Appendix A
Test method for the marked capacity of glass infusion bottles
(Supplement)
The marked capacity of infusion bottles can be selected from the following two methods, and the gravimetric method is adopted when loading. A1 Volumetric method
A1.1 Test equipment: horizontal workbench.
Volume flask (50~1000mL): It should comply with the provisions of QB701 Volumetric flask. Graduated pipette: accuracy is 0.1 mL,
A1.2 Test conditions: white rice water, ambient temperature is 5-~30℃, A1.3 Test method:
A1.3.1 The sample to be tested must be a dry, clean glass container that has not been subjected to any thermal and mechanical performance tests, A1.3.2 Inject tap water into a clean volumetric flask to the mark, and then pour the water in the volumetric flask into the sample to be tested to obtain mc (mL). A7.3.3 Place the sample to be tested injected with tap water on a water platform to observe whether the liquid surface line is consistent with the mark line. If it is inconsistent, use a graduated pipette to suck out or inject tap water, and the liquid surface of tap water of the sample towel is consistent with the mark line. Record the amount of tap water sucked out or injected m (mL). Injection is a positive value (+m (mL)), and suction is a negative value: m (mlL)). A1.4 Test results: The capacity m of the sample to be tested is calculated according to formula (A)). m=m± m
A2 Gravimetric method
A2.1 Test equipment: horizontal workbench.
Ordinary thermometer (0~50℃): graduation value is 1 degree. Graduation pipette: accuracy is 0.1 mL.
Balance: accuracy is 0.1g
A2,2 Test conditions: tap water, deionized water is used when necessary. Ambient temperature is 5~30℃. A2.3 Test method:
A2.3.7 The sample to be tested must be dry and clean, and has not been subjected to the test of heat resistance and mechanical properties. A2.3. 2 Place the sample to be tested on a large flat plate and weigh it, and record the mass m (g). (A1)
A2.3.3 Place the above sample on a horizontal workbench and inject tap water to the mark (first inject water to the mark and then suck it out with a pipette or inject water so that the liquid level is consistent with the sample mark). Note that the outer wall of the test should be kept dry. A2.3.4 Then weigh the sample filled with water on a balance and record the mass: (g). A2.4 Test results:
The mark capacity of the tested sample is calculated by formula (A2). m=(—)—1
Where 1 is the density of water, /mL.
Note: In this method, the density of tap water is approximately set to 1/mL. Considering the difference in water quality between the north and south of my country, it is stipulated that deionized water should be used when necessary, and the sieve size of deionized water is also approximately 1 area/mL. 135
Additional instructions:
This standard is proposed by the State Food and Drug Administration. GB2639—90
This standard is issued by the National Yaochuan Glass Product Quality Supervision, Inspection and Testing Center. This standard was drafted by Nantong Glass Factory No. 1.Aspirate as negative value: m (mlL). A1.4 Test results: The capacity m of the sample to be tested is calculated according to formula (A). m=m± m
A2 Gravimetric method
A2.1 Test equipment: horizontal workbench.
Ordinary thermometer (0~50℃): graduation value is 1 degree. Graduation pipette: accuracy is 0.1 mL.
Balance: accuracy is 0.1g
A2,2 Test conditions: tap water, deionized water is used when necessary. Ambient temperature is 5~30℃. A2.3 Test method:
A2.3.7 The sample to be tested must be dry, clean, and not subjected to the test of heat resistance and mechanical properties. A2.3. 2 Place the sample to be tested on a large flat 1 and weigh it, and record the mass m (g). (A1)
A2.3.3 Place the above sample on a horizontal workbench and inject tap water to the mark (first inject water to the mark and then suck it out with a pipette or inject water so that the liquid level is consistent with the sample mark). Note that the outer wall of the test should be kept dry. A2.3.4 Then weigh the sample filled with water on a balance and record the mass: (g). A2.4 Test results:
The mark capacity of the tested sample is calculated by formula (A2). m=(—)—1
Where 1 is the density of water, /mL.
Note: In this method, the density of tap water is approximately set to 1/mL. Considering the difference in water quality between the north and south of my country, it is stipulated that deionized water should be used when necessary, and the sieve size of deionized water is also approximately 1 area/mL. 135
Additional instructions:
This standard is proposed by the State Food and Drug Administration. GB2639—90
This standard is issued by the National Yaochuan Glass Product Quality Supervision, Inspection and Testing Center. This standard was drafted by Nantong Glass Factory No. 1.Aspirate as negative value: m (mlL). A1.4 Test results: The capacity m of the sample to be tested is calculated according to formula (A). m=m± m
A2 Gravimetric method
A2.1 Test equipment: horizontal workbench.
Ordinary thermometer (0~50℃): graduation value is 1 degree. Graduation pipette: accuracy is 0.1 mL.
Balance: accuracy is 0.1g
A2,2 Test conditions: tap water, deionized water is used when necessary. Ambient temperature is 5~30℃. A2.3 Test method:
A2.3.7 The sample to be tested must be dry, clean, and not subjected to the test of heat resistance and mechanical properties. A2.3. 2 Place the sample to be tested on a large flat 1 and weigh it, and record the mass m (g). (A1)
A2.3.3 Place the above sample on a horizontal workbench and inject tap water to the mark (first inject water to the mark and then suck it out with a pipette or inject water so that the liquid level is consistent with the sample mark). Note that the outer wall of the test should be kept dry. A2.3.4 Then weigh the sample filled with water on a balance and record the mass: (g). A2.4 Test results:
The mark capacity of the tested sample is calculated by formula (A2). m=(—)—1
Where 1 is the density of water, /mL.
Note: In this method, the density of tap water is approximately set to 1/mL. Considering the difference in water quality between the north and south of my country, it is stipulated that deionized water should be used when necessary, and the sieve size of deionized water is also approximately 1 area/mL. 135
Additional instructions:
This standard is proposed by the State Food and Drug Administration. GB2639—90
This standard is issued by the National Yaochuan Glass Product Quality Supervision, Inspection and Testing Center. This standard was drafted by Nantong Glass Factory No. 1.
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.