Some standard content:
National Standard of the People's Republic of China
Gloves
Rubber surgical gloves
Rubber surgical gloves
GB 7543-1996
Replaces GB7543-87
This standard is not equivalent to ISO/DIS10282:1990 "Specification for Single Use Sterile Surgical Rubber Gloves". 1Subject content and scope of application
This standard specifies the technical requirements and sampling methods of rubber gloves for medical surgery. This standard is recommended for medical gloves made of natural latex. 2 Reference standards
GB/T 528 Determination of tensile properties of vulcanized rubber and thermoplastic rubber GB/T2828 Batch-by-batch inspection and counting sampling procedures and sampling tables (applicable to inspection of consecutive batches) GB2941 Rubber sample environmental conditioning and test standard temperature , humidity and time GB/T3512 Rubber hot air aging test method GB/T5723 Determination of sample and product dimensions for testing vulcanized rubber or thermoplastic rubber GB/T14831 Steam aging test method for latex products 3 Classification
Can be divided into categories by variety Two categories:
Smooth: The surface of the glove is smooth,
Non-glossy: The surface of the glove is textured or pitted. 4 Material
Gloves should be made of natural concentrated latex. Any materials used should be safe and harmless. Any surface treatment that facilitates the wearing of gloves, such as powders, release agents, and lubricants should be stated as required. Any surface treatment should be bioabsorbable. 5 Structure
5.1 The thumb of the glove should be in front of the index finger, not on the side, for easy operation. 5.2 The cuffs should be rolled tightly and completely without twisting. 6 Technical Requirements
6.1 Specifications
The dimensions of the main parts of the gloves are measured according to 7.1 and should comply with the provisions of Table 1. State Bureau of Technical Supervision approved the implementation on 1997-03-01 on 1996-12-20
11
project
specification
length, not less than
width| |tt||Single layer thickness
Glossy
Non-glossy
6.2 Appearance
6
255
77±5| |tt||6 yuan
255
GB7543—1996
Table 1
7
265
83±5||tt ||Appearance defects that seriously affect use are not allowed. 6.3 Tensile properties
89±5
265
95±5
not less than 0.10
not less than 0.13
When the elongation performance is tested according to 7.2, the results should comply with the requirements in Table 2. Table 2
Item
Before aging
(70℃×7d or 100℃×22h) After heat aging
After cooking six times at 0.098MPa×30min|| tt||6.4 Water impermeability
100
Tensile strength, MPa
Elongation at break, %
300% modulus stress*MPa||tt ||Tensile strength, MPa
Elongation at break, %
Tensile strength, MPa
Elongation at break, %
According to Appendix A ( When conducting the water leakage test using the method shown in Supplement), the gloves should not leak. 6.5 Electrical conductivity
When tested according to Appendix B (Supplement), the indicated current should not be greater than 10-2A Note: Electrical conductivity is a non-mandatory requirement. 7 Test method
7.1 Specifications
8
275
102±6
Indicator
not less than 24
not Less than 750
Not less than 3
Not less than 18
Not less than 560
Not less than 20
Not less than 750
mm|| tt | | 8 | | tt | | 275 | | tt | Measure the length and width of the glove in position (a) and position (b) shown in 1.
7.1.2 Thickness measurement
Use a thickness meter that meets the requirements of GB/T5723 and has a foot pressure of 22±5KPa to measure on a complete glove corresponding to A and B shown in Figure 2 , the double-layer thickness at each point C, half of the double-layer thickness is recorded as the single-layer thickness. Point A: 15mm from the top of the middle finger #
Point B: Approximately the center of the palm;
Point C: 25 mm from the edge of the sleeve.
When there is marginal data in the measurement or there is a dispute about the thickness (including thin spots in key parts), the glove should be cut open and measured to obtain the single layer thickness of the relevant part.
7.2 Appearance inspection
12
Q#7543-1996
Figure 1 Length and width measurement position
5
Figure 2 Thickness Measurement position
13
GB 7543--1996
Check the gloves manually when the rubber film is inflated and expanded approximately one to one time. The wrist area is stretched and expanded by hand. The fingers generally do not expand. When defects are found, they can be partially expanded for inspection. 7.3 Tensile properties
The specimens used in the tensile test before aging, after heat aging and after cooking aging should be cut on the palm or sleeve of an unused glove using the type 2 cutter specified in GB/T528 Cut out (smooth parts should be taken as much as possible). 7.3.1 The tensile properties before aging shall be measured in accordance with the test methods specified in GB/T528. 7.3.2 To measure the tensile properties after thermal aging, the sample should be placed in an oven at 70±2℃ (or 100±2℃) according to the test method specified in GB/T3512 after aging for 7d (or 22±0.3h). , within 4÷96h, conduct the test according to the test method specified in GB/T528. 7.3.3 The tensile properties after cooking and aging should be measured according to the test method specified in GB/T14831. After cooking at 0.098MPaX30min for six times, within 16 to 144h, the test should be carried out according to the test method specified in GB/T528. 7.4 The water impermeability should be tested according to the test method specified in Appendix A (Supplement). 7.5 The electrical conductivity should be tested in accordance with the test methods specified in Appendix B (Supplement). 8 Acceptance rules
The unit product for sampling inspection is a pair of gloves. 8.1
8.2 According to GB/T2828, batching and sampling, inspection level (IL) and qualified quality level (AQL) should comply with the provisions of Table 3. Table 3
Properties
Performance
Specifications (length, width, thickness)
Impermeability
Physical properties
(before aging , after heat aging, after cooking aging) conductive properties
IL
S-2
S-4
S-2
S-4| |tt||8.3 When the test results do not exceed the AQL value specified in Table 3, the gloves can be considered to meet the requirements of this standard. AQL | | tt | | 4.0 | | tt | | 1.5 | | tt | | 4.0 | | tt | | 4.0 | requirements of this standard. Unqualified items can be subject to stricter sampling inspection once. If they are still unqualified, the batch of products will be deemed unqualified. 8.5 When the process conditions remain unchanged, the thermal aging test should be conducted at least once every half month. The two test conditions of the thermal aging test can be selected at will. The arbitration test condition is (70±2)℃×7d. 8.6 The acceptance of the appearance of gloves shall be agreed upon by both parties. 9 Packaging and marking
9.1 Packaging materials
There are two types of packaging: sterile and non-sterile. Sterile packaging should have double packaging. All packaging materials should have sufficient strength and not contain substances that are harmful to the quality of the gloves and the users, so that the gloves will not be damaged during normal transportation and storage, and the users will not be damaged during normal use. 9.2 Marking
The palm surface of each glove should be close to the center, and there should be a clear specification mark that cannot be washed away at a distance of 20.mm from the edge. For quick identification, the sleeve edge can also be painted with a color that complies with Table 4 in place of the corresponding specification mark. Table 4
Specifications
Color
9.3 Sterile packaging mark
14
Orange
No. 6
Blue| |tt||7
red
black
8
green
8
yellow
9.3.1Inner packaging
GB 7543-1996
Glove gloves are put into an inner packaging, and the inner packaging should be marked with "left" or "right" in the position corresponding to the gloves. 9.3.2 Unit packaging
The inner packaging is placed in a sealed bag, which is the unit packaging. The unit packaging should be marked with the following content: a.
b.
d.||tt| |e.
f.
9.3.3
Manufacturer name,
Product name, category;
Specification or color mark:||tt ||Manufacturing date or production batch number:
"Unless opened or damaged, this package is sterile", sterilization method, time and sterilization validity period. Medium packaging
Packing half a unit of the same specifications into one box is called medium packaging. The medium packaging should be marked with the following content: a.
b.
c||tt| |d.
e.
f.
9.3.4
Manufacturer name,
Product name, category;
Specifications Or color mark,
manufacturing date or production batch number;
number of gloves inside;
standard code.
Outer packaging
Pack several intermediate packages of the same specifications into one box for safe transportation and storage. The outer packaging should be marked with the following: a.
b.
c.
d.
e.
f.
g .
Manufacturer name,
Product name, category;
Specification or color mark;
Manufacturing date or production batch number,
Quantity of gloves inside;
Sterilization method, time and sterilization validity period, standard code.
9.4 Non-sterile packaging mark
9.4.1
a.
b.
c.
Unit packaging||tt ||The two-hand set put into one bag is the unit package. The unit package should be marked with the following: manufacturer name;
product name, category,
specification or color mark;
d.
Manufacturing date or production batch number.
9.4.2
Intermediate packaging
Packaging several units of the same specification into one box is called intermediate packaging. The intermediate packaging should be marked with the following: a.
b.
c.
d.
e.
f.
Manufacturing name,
Product name, category,| |tt||Specification or color mark;
Manufacturing date or production batch number;
Quantity of gloves inside:
Standard code.
3 outer packaging
9.4.3
15
GB75431996
Pack several intermediate packages of the same specifications into one box for safe transportation and Storage. The outer packaging should be marked with the following: a.
b.
c.
d.
e.
f.
Manufactured Factory name; bZxz.net
Product name, category,
Specification or color mark,
Manufacturing date or production batch number,
Number of gloves inside;
Standard code .
10 Transportation and Storage
10.1 Gloves should be covered during transportation and placed in a dry place, away from moisture and heat. 10.2 Gloves should be stored in a well-ventilated, cool and dry warehouse (indoor temperature is preferably below 30°C and relative humidity below 80%), 20cm above the ground. Direct exposure to sunlight or strong artificial light with high UV content should be avoided, and there should be no devices that can generate ozone in the warehouse.
10.3 Gloves must not come into contact with oil, acid, alkali, copper, manganese and other substances harmful to rubber during storage. 10.4 Under the above storage conditions, the tensile strength of gloves should not be less than 18MPa within 12 to 18 months from the date of manufacture. The tensile strength should not be less than 16MPa after cooking six times.
16
A1 wilting volume
GB 7543-1996
With nest A
Xiao Shui Qian
(livestock parts)| |tt||A1. 1 A device that can clamp gloves and keep them in a vertical state when filled with water. The dimensions of this device are as shown in Figure A1. A1.2 Simple measurement, customer volume is 1000mL.
A2 step set
tool. Tie the gloves on the hollow stick with an outer diameter of 6cm in the device, lift the cuff edge to 3.8cm, and tie it tightly with an elastic band to prevent water from flowing out. See Figure A2.
b. Under room condensation, fill the chamber with 1000 mL of water. After hanging for at least 2 minutes, observe whether there is water and make a record. If the first glove in a pair of gloves is not thin, you should continue to follow step A2 for the second glove to earn the test. If one of the gloves leaks, the pair of gloves is deemed unqualified. If a pair of gloves contains no water, then the gloves are made of sugar. 93
A
A-
A
Figure Al
s
Internal table and line mark
17| |tt||B1 device
This test device is shown in Figure B1.
B2 Reagent
3.75% sodium chloride aqueous solution.
Step B3
GB7543—1996
Figure A2
Appendix B
Conductive Performance Test
(Supplement)||tt| |Put the glove on the stent collar, fill the glove with 3.75% sodium fluoride aqueous solution to a depth of 200±10mm, and immerse it in the sodium chloride aqueous solution at 37±2°C, as shown in Figure B1. Then insert an electrode into the glove and turn on the 24V, 50Hz alternating current. After 30 minutes, record the current value indicated by the microammeter.
18
Additional notes:
Hui'an Plan
GB7543—1996
Current Stabilizer
24V50H
Figure B1
This standard is proposed by the Ministry of Chemical Industry of the People's Republic of China. This standard is under the jurisdiction of the Latex Industry Research Institute of the Ministry of Chemical Industry. This standard is drafted by the Latex Industry Research Institute of the Ministry of Chemical Industry. The main drafters of this standard are Li Xiaomei, Ruan Xu and Tan Yunhua. Recorder
N
hy
3.759%6 sodium chloride
water enzyme solution
insulated stainless steel
19
| |tt | Color mark;
d.
Manufacturing date or production batch number.
9.4.2
Intermediate packaging
Packaging several units of the same specification into one box is called intermediate packaging. The intermediate packaging should be marked with the following: a.
b.
c.
d.
e.
f.
Manufacturing name,
Product name, category,| |tt||Specification or color mark;
Manufacturing date or production batch number;
Quantity of gloves inside:
Standard code.
3 outer packaging
9.4.3
15
GB75431996
Pack several intermediate packages of the same specifications into one box for safe transportation and Storage. The outer packaging should be marked with the following: a.
b.
c.
d.
e.
f.
Manufactured Factory name;
Product name, category,
Specification or color mark,
Manufacturing date or production batch number,
Number of gloves inside;
Standard code .
10 Transportation and Storage
10.1 Gloves should be covered during transportation and placed in a dry place, away from moisture and heat. 10.2 Gloves should be stored in a well-ventilated, cool and dry warehouse (indoor temperature is preferably below 30°C and relative humidity below 80%), 20cm above the ground. Direct exposure to sunlight or strong artificial light with high UV content should be avoided, and there should be no devices that can generate ozone in the warehouse.
10.3 Gloves must not come into contact with oil, acid, alkali, copper, manganese and other substances harmful to rubber during storage. 10.4 Under the above storage conditions, the tensile strength of gloves should not be less than 18MPa within 12 to 18 months from the date of manufacture. The tensile strength should not be less than 16MPa after cooking six times.
16
A1 wilting volume
GB 7543-1996
With nest A
Xiao Shui Qian
(livestock parts)| |tt||A1. 1 A device that can clamp gloves and keep them in a vertical state when filled with water. The dimensions of this device are as shown in Figure A1. A1.2 Simple measurement, customer volume is 1000mL.
A2 step set
tool. Tie the gloves to the hollow stick with an outer diameter of 6cm in the device, lift the cuff edge to 3.8cm, and tie it tightly with an elastic band to prevent water from flowing out. See Figure A2.
b. Under room condensation, fill the chamber with 1,000 mL of water. After hanging for at least 2 minutes, observe whether there is water and make a record. If the first glove in a pair of gloves is not thin, you should continue to follow step A2 for the second glove to earn the test. If one of the gloves leaks, the pair of gloves is deemed unqualified. If a pair of gloves contains no water, then the gloves are made of sugar. 93
A
A-
A
Figure Al
s
Internal table and line mark
17| |tt||B1 device
This test device is shown in Figure B1.
B2 Reagent
3.75% sodium chloride aqueous solution.
Step B3
GB7543—1996
Figure A2
Appendix B
Conductive Performance Test
(Supplement)||tt| |Put the glove on the stent collar, fill the glove with 3.75% sodium fluoride aqueous solution to a depth of 200±10mm, and immerse it in the sodium chloride aqueous solution at 37±2°C, as shown in Figure B1. Then insert an electrode into the glove and turn on the 24V, 50Hz alternating current. After 30 minutes, record the current value indicated by the microammeter.
18
Additional notes:
Hui'an Plan
GB7543—1996
Current Stabilizer
24V50H
Figure B1
This standard is proposed by the Ministry of Chemical Industry of the People's Republic of China. This standard is under the jurisdiction of the Latex Industry Research Institute of the Ministry of Chemical Industry. This standard is drafted by the Latex Industry Research Institute of the Ministry of Chemical Industry. The main drafters of this standard are Li Xiaomei, Ruan Xu and Tan Yunhua. Recorder
N
hy
3.759%6 sodium chloride
water enzyme solution
insulated stainless steel
19
| |tt | Color mark;
d.
Manufacturing date or production batch number.
9.4.2
Intermediate packaging
Packaging several units of the same specification into one box is called intermediate packaging. The intermediate packaging should be marked with the following: a.
b.
c.
d.
e.
f.
Manufacturing name,
Product name, category,| |tt||Specification or color mark;
Manufacturing date or production batch number;
Quantity of gloves inside:
Standard code.
3 outer packaging
9.4.3
15
GB75431996
Pack several intermediate packages of the same specifications into one box for safe transportation and Storage. The outer packaging should be marked with the following: a.
b.
c.
d.
e.
f.
Manufactured Factory name;
Product name, category,
Specification or color mark,
Manufacturing date or production batch number,
Number of gloves inside;
Standard code .
10 Transportation and Storage
10.1 Gloves should be covered during transportation and placed in a dry place, away from moisture and heat. 10.2 Gloves should be stored in a well-ventilated, cool and dry warehouse (indoor temperature is preferably below 30°C and relative humidity below 80%), 20cm above the ground. Direct exposure to sunlight or strong artificial light with high UV content should be avoided, and there should be no devices that can generate ozone in the warehouse.
10.3 Gloves must not come into contact with oil, acid, alkali, copper, manganese and other substances harmful to rubber during storage. 10.4 Under the above storage conditions, the tensile strength of gloves should not be less than 18MPa within 12 to 18 months from the date of manufacture. The tensile strength should not be less than 16MPa after cooking six times.
16
A1 wilting volume
GB 7543-1996
With nest A
Xiao Shui Qian
(livestock parts)| |tt||A1. 1 A device that can clamp gloves and keep them in a vertical state when filled with water. The dimensions of this device are as shown in Figure A1. A1.2 Simple measurement, customer volume is 1000mL.
A2 step set
tool. Tie the gloves to the hollow stick with an outer diameter of 6cm in the device, lift the cuff edge to 3.8cm, and tie it tightly with an elastic band to prevent water from flowing out. See Figure A2.
b. Under room condensation, fill the chamber with 1,000 mL of water. After hanging for at least 2 minutes, observe whether there is water and make a record. If the first glove in a pair of gloves is not thin, you should continue to follow step A2 for the second glove to earn the test. If one of the gloves leaks, the pair of gloves is deemed unqualified. If a pair of gloves contains no water, then the pair of gloves is made of sugar. 93
A
A-
A
Figure Al
s
Internal table and line mark
17| |tt||B1 device
This test device is shown in Figure B1.
B2 Reagent
3.75% sodium chloride aqueous solution.
Step B3
GB7543—1996
Figure A2
Appendix B
Conductive Performance Test
(Supplement)||tt| | Put the glove on the stent collar, fill the glove with 3.75% sodium fluoride aqueous solution to a depth of 200±10mm, and immerse it in the sodium chloride aqueous solution at 37±2°C, as shown in Figure B1. Then insert an electrode into the glove and turn on the 24V, 50Hz alternating current. After 30 minutes, record the current value indicated by the microammeter.
18
Additional notes:
Hui'an Plan
GB7543—1996
Current Stabilizer
24V50H
Figure B1
This standard is proposed by the Ministry of Chemical Industry of the People's Republic of China. This standard is under the jurisdiction of the Latex Industry Research Institute of the Ministry of Chemical Industry. This standard is drafted by the Latex Industry Research Institute of the Ministry of Chemical Industry. The main drafters of this standard are Li Xiaomei, Ruan Xu and Tan Yunhua. Recorder
N
hy
3.759%6 sodium chloride
water enzyme solution
insulated stainless steel
19
75% sodium fluoride aqueous solution to a depth of 200 ± 10 mm, and immersed in a sodium chloride aqueous solution at 37±2°C, as shown in Figure B1. Then insert an electrode into the glove and turn on the 24V, 50Hz alternating current. After 30 minutes, record the current value indicated by the microammeter.
18
Additional notes:
Hui'an Plan
GB7543—1996
Current Stabilizer
24V50H
Figure B1
This standard is proposed by the Ministry of Chemical Industry of the People's Republic of China. This standard is under the jurisdiction of the Latex Industry Research Institute of the Ministry of Chemical Industry. This standard is drafted by the Latex Industry Research Institute of the Ministry of Chemical Industry. The main drafters of this standard are Li Xiaomei, Ruan Xu and Tan Yunhua. Recorder
N
hy
3.759%6 sodium chloride
water enzyme solution
insulated stainless steel
19
75% sodium fluoride aqueous solution to a depth of 200 ± 10 mm, and immersed in a sodium chloride aqueous solution at 37±2°C, as shown in Figure B1. Then insert an electrode into the glove and turn on the 24V, 50Hz alternating current. After 30 minutes, record the current value indicated by the microammeter.
18
Additional notes:
Hui'an Plan
GB7543—1996
Current Stabilizer
24V50H
Figure B1
This standard is proposed by the Ministry of Chemical Industry of the People's Republic of China. This standard is under the jurisdiction of the Latex Industry Research Institute of the Ministry of Chemical Industry. This standard is drafted by the Latex Industry Research Institute of the Ministry of Chemical Industry. The main drafters of this standard are Li Xiaomei, Ruan Xu and Tan Yunhua. Recorder
N
hy
3.759%6 sodium chloride
water enzyme solution
insulated stainless steel
19
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