GB 15593-1995 Soft polyvinyl chloride plastic for blood transfusion (liquid) equipment
Some standard content:
National Standard of the People's Republic of China
Plasticized pol yvinyl chloride (PVC) compounds for transfusion (infusion) equipment. This standard adopts ISO3826-1993 "Human Blood and Blood Products". Plastic Containers》1 Subject content and scope of application
GB15593-1995
This standard specifies products of soft polyvinyl chloride plastics for blood transfusion (liquid) equipment (hereinafter referred to as plastics for blood transfusion (liquid) equipment) Classification, technical requirements, test methods, inspection rules and markings, packaging, transportation, storage, etc. This standard applies to blood transfusion (liquid) products made from special polyvinyl chloride resin plasticized with di(2-ethylhexyl) phthalate (DEHP) as the main body, adding necessary additives, mixing and plasticizing ) Plastics for appliances. The plastic is mainly used to make disposable blood transfusion (liquid) blown film bags, catheters, droppers and other medical accessories. 2 Reference standards
GB/T1040 Plastic tensile properties test method GB/T2411
GB/T2917
GB/T4615
Plastic Shore hardness test method||tt ||Thermal stability test method of polyvinyl chloride—Congo red method and pH method Determination method of residual vinyl fluoride monomer content in polyvinyl chloride resin General principles for sampling of chemical products
GB/T6678
GB/T9345 General determination method for plastic ash content Disposable plastic blood bags
GB/T14232
GB/T14233.1 Test methods for medical infusions, blood transfusions and injection equipment Part 1: Chemical analysis methods GB/T14233.2 Medical Inspection Methods for Infusion, Blood Transfusion and Injection Equipment Part 2: Biological Test Methods Pharmacopoeia of the People's Republic of China 1977 Edition
3 Product Categories
3.1 Product Models
Product models are classified by use, by key The word consists of the first letters of English. M stands for Medical;
F stands for Film;
T stands for Tube;
D stands for Dropper.
See Table 1 for product models and uses.
State Bureau of Technical Supervision approved on 1995-06-12 for implementation on 1995-12-01
Type
No.
MF
MT
MD | Soft polyvinyl chloride plastic for blood transfusion (liquid) catheters. Soft polyvinyl chloride plastic for blood transfusion (liquid) droppers.
Plastics for blood transfusion (liquid) equipment are generally cylindrical particles, and their outer dimensions are about 3~4mm in diameter. , the length is about 2~3mm, or granular objects of other shapes of considerable size.
4 Technical Requirements
4.1 Appearance
Plastics for blood transfusion (liquid) equipment are colorless or almost colorless transparent granules. The plasticization should be uniform and free of foreign impurities. 4.2 Physical and chemical properties
4.2.1 The physical and mechanical properties of plastics used in blood transfusion (fluid) equipment should comply with the requirements in Table 2. Table 2
Test items
Water absorption, %
Hardness (Shore A)
Tensile strength, MPa
Elongation at break, %
180C thermal stabilization time, min
MF
≤0.3
≤80
>13.0
≥250
≥40
2 The chemical properties of plastics used in blood transfusion (liquid) equipment should comply with the requirements in Table 3. 4.2.2
Table 3
Test items
Chemical properties of water leachables
Reducing substances (0.02mol/LKMnO, consumption), ml/20mL pH (with Difference in pH value of blank control solution) Non-volatile matter, mg/100mL
Color
Heavy metals, μg/mL
Zinc, μg/mL
UV absorption ( 230~360nm)
Alcohol extractables (DEHP), mg/100mL
Pellet chemical properties
Ash, mg/g
Vinyl chloride monomer, ug/ g
refers to
MT
≤80
≥13.0
≥250
≥40
standard||tt ||MD
>80
>18.0
≥200
≥40
refers to
MF
≤0.3
≤1.0
≤2.0
Clear and colorless
0.3
≤0.4
≤0.3
≤10| |tt||1
1
MT
≤0.3
≤1.0
≤2.0
Clear and colorless||tt| |N0.3
0.4
≤0.3
≤1
1
standard
MD
0.3|| tt||1.0
≤2.0
Clear and colorless
≤0.3
≤0.4
≤0.3
1||tt| |4.3 Biological properties
GB15593-1995
The biological properties of plastics used in blood transfusion (liquid) equipment should comply with the provisions of Table 4. Table 4
Test items
pyrogens
hemolysis
acute systemic toxicity
cytotoxicity
intradermal irritation
Allergy
Blood preservation
5 test methods
5.1 Appearance
No pyrogen
Hemolysis rate ≤5%
MF|| tt||Does not produce acute systemic toxicity
Cultivation in medium containing extract solution for 7
days, the proliferation rate of 1-929 cell line is not greater than level 2
Domestic free transdermal After internal injection of the extract, there will be no obvious erythema or edema within 72h
Allergic reaction is less than grade 2
Allergy rate is not more than 28%
Blood transfusion made of plastic When the bag stores blood at 4 ± 2°C for 21 days, it should not be hemolyzed. The alcoholysis rate of red blood cells should not be less than 70%. Under natural light, observe with the naked eye.
5.2 Sample preparation
refers to
pyrogen-free
hemolysis rate ≤5%
MT
standard||tt| |Does not produce acute systemic toxicity
Cultivation in medium containing extract solution for 7
days, the proliferation rate of 1-929 cell line is not greater than level 2
Free of intradermal injection After extracting the liquid, there is no obvious erythema or edema within 72h
Allergic reaction is less than grade 2
Allergy rate is not more than 28%
No pyrogen|| tt||Hemolysis rate ≤5%
MD
Does not produce acute systemic toxicity
Cultured in medium containing extract solution for 7
days, 1-929 cells The proliferation degree of the strain is not greater than grade 2
After intradermal injection of the diffuse extract, there is no obvious erythema or edema within 72h
The allergic reaction is less than grade 2||tt| |The allergy rate is not greater than 28%
After mixing, the pellets sampled according to 6.2 are mixed in a small open mill at a temperature of 160 ± 3°C for 5 to 8 minutes, and then molded in a mold at a temperature of 160 to 165°C The hot plate press presses the material, raises the temperature from preheating, and pressurizes it for about 10 to 15 minutes, and then passes cooling water under pressure to cool and eject the mold. The sample should be transparent and the surface should be flat and smooth.
5.2.1 See Table 5 for sample thickness requirements.
Table 5
Test items
Hardness
Tensile strength and elongation at break
Water absorption, chemical properties of water extractables, pyrogen, Acute systemic toxicity test hemolysis, cytotoxicity, intradermal irritation and allergy 5.2.2 Thermal stability time and chemical properties of pellets The samples are all pellets. 5.2.3 Alcohol leachables and blood storage test samples are in blood bags. 5.3 Physical and mechanical properties
5.3.1 Water absorption
Sample thickness,mm
>5
2.0±0.2
0.45±0.05
0.35±0.05
According to "Plastics for Blood Transfusion" in the 1977 edition of the Pharmacopoeia of the People's Republic of China Container Inspection Act" regulations. 5.3.2 Hardness
GB15593-1995
shall be carried out in accordance with the provisions of GB/T2411. The hardness tester adopts Shore A, applies a load of 1.00±0.01kg, a time of 15s, and no less than 5 test points.
5.3.3 Tensile strength and elongation at break
According to the regulations of GB/T1040. The sample thickness is 2.0±0.2mm; test speed (no load): 250±50mm/min. 5.3.4180℃ thermal stabilization time
shall be carried out according to the Congo Red method in GB/T2917. 5.4 Chemical properties
5.4.1 Chemical properties of water leachables
5.4.1.1 Preparation of test solution
Take the area as 300cm (the total area of ??the two sides is 600cm2), and the thickness is Wash the uniform part of the 0.45±0.05mm flake sample with soapy water, tap water, and distilled water in sequence, dry it, cut it into 1cm pieces, and then add it to the glass container. According to the total surface area of ??the sample (cm) and water (mL ), add 300 mL of distilled water with a pH value of 5.5 to 6.5 at a ratio of 2:1, seal it with an appropriate method, place it in a pressure steam sterilizer, and heat it at 121 ± 1°C for 20 minutes. After heating, separate the sample and liquid Separate and cool to room temperature as test solution. 5.4.1.2 Preparation of blank control solution
Use the same batch of distilled water without adding test pieces and operate in the same way to prepare the blank control solution. 5.4.1.3 pH
shall be carried out in accordance with the provisions of Article 7.4 in GB/T14233.1. 5.4.1.4 Reducing substances
shall be carried out in accordance with the provisions of Article 7.2 in GB/T14233.1. 5.4.1.5 Non-volatile matter
shall be carried out in accordance with the provisions of Article 7.5 in GB/T14233.1. 5.4.1.6 Color
Take 50mL of the test solution and place it in a Nessler colorimetric tube. Use white material as the background and visually compare it under a fluorescent lamp. It should not be turbider than the control distilled water. It should be clear and colorless.
5.4.1.7 Heavy metals
According to the provisions of Chapter 3 in GB/T14233.1. 5.4.1.8 Zinc
shall be carried out in accordance with the provisions of 4.2.5 in GB/T14233.1. 5.4.1.9 Ultraviolet light absorption
Take the test solution, use the blank control solution as a reference, and use a 1cm absorption cell to measure the maximum UV absorption value in the wavelength range of 230 to 360nm.
5.4.2 Alcohol extractables (DEHP)
According to the provisions of Article A.2.2 in GB/T14232. 5.4.3 Chemical properties of pellets
5.4.3.1 Ash content
According to the provisions of Method B in GB/T9345.
5.4.3.2 Vinyl chloride monomer
According to the regulations of GB/T4615.
5.5 Biological properties
5.5.1 Pyrogen
5.5.1.1 Preparation of test solution
Take the area as 60cm (the total area of ??the two sides is 120cm* ), the uniform part of the sheet sample with a thickness of 0.45±0.05mm, wash it with soapy water, tap water and distilled water in sequence GB15593-1995
, dry it, cut it into 5mm×30mm strip test pieces, and put Put it into a stoppered Erlenmeyer flask, rinse it three times with sterile, non-pyrogenic 0.9% sodium chloride injection, then add 20 mL of 0.9% sodium chloride injection of the same batch number, so that the liquid is immersed in the sample, seal it and then sterilize it with high-pressure steam. Extract at 121°C and 2°C for 60 minutes. 5.5.1.2 Test
shall be carried out in accordance with the provisions of Chapter 3 of GB/T14233.2. 5.5.2 Acute systemic toxicity
5.5.2.1 Preparation of test solution
Same as 5.5.1.1.
5.5.2.2 Test
Conducted in accordance with the provisions of Chapter 5 of GB/T14233.2. 5.5.3 Hemolysis, cytotoxicity, intradermal irritation and allergy shall be carried out according to the provisions of Chapters 6, 7, 8 and 9 of GB/T14233.2. 5.5.4 Blood preservation
should be carried out in accordance with the "Blood Preservation Test Methods" in Appendix 2 of the 1977 edition of the Pharmacopoeia of the People's Republic of China. 6 Inspection Rules
6.1 When inspecting, the unit is batch. The same product produced with the same formula, the same raw materials, and the same process is regarded as a batch. The quantity of each batch shall not exceed 5t, or based on the shift output.
6.2 Sampling shall be in accordance with the provisions of GB/T6678. The number of sampling units shall be in accordance with the provisions of Table 2 in GB/T6678. The sampling unit shall be counted in packaging bags. Uniform and representative samples are allowed to be taken on the production line or packaging line. . The sampling volume must be at least 3kg, mix the samples evenly, and indicate the manufacturer's name, product name, model, batch number and sampling date on the sampling bag. 6.3 Each batch of products must be inspected by the quality inspection department of the manufacturer to ensure that all products leaving the factory meet the requirements of this standard. Each batch of products should have a quality inspection report.
6.4 Inspection is divided into factory inspection, random inspection and type inspection. 6.4.1 Factory inspection items for each batch of products:
4.1 Appearance; Www.bzxZ.net
4.2 Tensile strength and elongation at break in Table 2; 4.2 Reducing substances, pH, color, Heavy metal. 6.4.2 Items for product sampling every three months include water absorption, hardness, and thermal stability time in Table 2 of Article 4.2; nonvolatile matter, zinc, and ultraviolet light absorption in Table 3 of Article 4.2. 6.4.3 Items for annual sampling of products: alcohol leachables, ash, and vinyl chloride monomer in Table 3 of Article 4.2. 6.4.4 Product type inspection items:
MF shall be inspected according to the items specified in Table 2, Table 3 and Table 4 in Articles 4.1 and 4.2; MT and MD shall be inspected according to Tables 2 and 4 in Articles 4.1 and 4.2 3. Test pyrogens, hemolysis, and acute systemic toxicity in Table 4. Type inspection should be carried out when one of the following situations occurs: a. Trial type identification of new products or old products transferred to factory production (MT and MD must add cytotoxicity test, intradermal irritation test, allergy test);
b. After formal production, if there are major changes in the formula, raw materials, and processes, which may affect product performance (MT and MD must add cytotoxicity test, intradermal irritation test, and overload test); c. During normal production, two years Conduct an inspection; d. When the product resumes production after a long-term suspension; GB15593-1995
e. When the national quality supervision agency requests type inspection. 6.5 If the user unit needs to inspect the received products, it should be carried out in accordance with the provisions of this standard. The acceptance inspection should be carried out within one month after receiving the products.
6.6 If any item of the inspection results does not meet the standard requirements, double the number of sampling units should be taken from the batch of products and the unqualified items should be re-inspected. If the re-inspection results are still unqualified, then the The batch of products is defective. 6.7 When the supply and demand parties have objections to product quality, the two parties shall negotiate to resolve the dispute or ask the statutory quality inspection department for arbitration. 7 Marking, packaging, transportation and storage
7.1 Mark
There should be a clear and firm mark on each bag of packaging, indicating the name of the manufacturer, trademark, product name, product standard number, model, Batch number, net weight, manufacturing date. It is accompanied by a product certificate from the quality inspection department of the manufacturer. 7.2 Packaging | Plastic bag, the inner packaging bag is double-packed with two polyethylene-lined bags. Fill according to measured value, net weight of each bag is 25kg. It can also be packaged according to the packaging form and measurement negotiated by both parties.
7.3 Transportation
When transporting plastics for blood transfusion (liquid) equipment, pay attention to dryness, keep them clean, and avoid exposure to the sun and rain; handle them with care during transportation to avoid rupture and damage to the packaging bags. This product is a non-hazardous product: 7.4 Storage
Plastics for blood transfusion (fluid) equipment should be stored in a clean, dry, and ventilated warehouse. They should not be exposed to heat sources and organic solvents, and should not be exposed to direct sunlight.
Additional notes:
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 Plastic Resin Products Branch of the National Plastics Standardization Technical Committee. The main drafting units of this standard are: Shanghai Chemical Plant, Shandong Medical Device Research Institute, and Shanghai Blood Center. Units participating in the drafting of this standard: Blood Transfusion Institute of the Chinese Academy of Medical Sciences, Shanghai Changzheng Pharmaceutical Factory, Shanghai Plastic Products Factory No. 2, Shanghai Dahua Medical Plastic Factory, Changshu Medical Equipment Factory.
The main drafters of this standard: Yu Meiling, Shi Ping, Lang Jiexian, Dong Xiangzhen, Qin Dongli, Zhu Huihong.
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