Some standard content:
3. For medical and food industry use
Rubber product standards
National Standard of the People's Republic of China
Rubber transfusion tubes
Rubber transfusion tubes
Theme content and application Scope
GB 4491--93
Replaces GB4491-84
This standard specifies the technical requirements, test methods, acceptance rules, packaging, marking, storage and transportation of blood transfusion hoses. This standard applies to round blood transfusion and infusion catheters made of natural latex. Referenced standards
2bzxZ.net
GB/T528 Determination of tensile properties of vulcanized rubber and thermoplastic rubber Preparation of standard solution for chemical reagent titration analysis (volume analysis) GB 601
GB602||tt| |GB 603
Preparation of standard solutions for determination of impurities in chemical reagents Preparation of preparations and products used in chemical reagent test methods Batch-by-batch inspection and counting Sampling procedures and sampling tables (applicable to inspection of consecutive batches) GB2828||tt| |GB/T3512 Rubber Hot Air Aging Test Method GB/T14831 Latex Products Steam Aging Test Method HG/T2198 Vulcanized Rubber Physical Test Method General Requirements for Inspection of Plastic Containers and Infusion Plastic Utensils for Blood Transfusion Factory "Pharmacopoeia of the People's Republic of China" (1990 Year WS1-C6-0002#
Version 1 and 2)
3 Raw materials
Blood transfusion hoses should be made of natural rubber latex and additives that are harmless to the human body. The selection of raw materials must ensure that the product first meets the chemical and biological test requirements specified in this standard.
4 Technical requirements
The specifications of blood transfusion hoses should comply with the requirements in Table 1. 4.1
Table 1
Specifications
Inner diameter × outer diameter
2×4
3×5
4×6||tt ||5×7
6×9
Basic size
2.0
3.0
4.0
5.0
6.0
Inner diameter approved by the State Bureau of Technical Supervision on December 30, 1993
Limit deviation
+0.2
±0.3
Basic size
1.0
1.0
1.0
1.0
1.5
Wall thickness
Limit deviation
±0.2
Implemented on 1994-10-01
3
GB 4491 ---93
4.2 The physical properties of blood transfusion hoses should comply with the provisions of Table 2. Table 2
Item
Item
Tensile strength, MPa is not less than
Elongation at break, % is not less than
Before aging||tt ||After aging
(70±2℃)×(166±2h) or (100±2℃)×(22±0.3h) 21
700
4.3 blood transfusion hose The chemical test results of the leachate should comply with the requirements in Table 3. Table 3
item
sulfur
arsenic
zinc
item
heavy metals (measured as lead)
calcium| | tt | 16
500
Maximum content, 10-\(m/m)
15.0
0. 20
3.0
1.0| | tt | There are a few tiny white spots. 4.6 The pH value difference of the blood transfusion hose flushing solution:
Tested according to 6.5, the pH value difference between the sodium chloride injection before and after flushing shall not exceed 1.0. 4.7 The biological test of the blood transfusion hose leachate shall meet the following requirements: a. || tt | It shall not exceed 3.5℃; during the hemolysis test, the hemolysis rate in the initial test or retest shall not exceed 5%. 4.8 The appearance quality of blood transfusion hoses should meet the following requirements: a.
b.
c
The tube wall should be transparent when tested according to 5.2;
The inner surface is smooth and the outer surface Minor defects such as unobvious bamboo joints are allowed; bubbles with a diameter of less than 0.3mm and a spacing of not less than 10mm are allowed in the pipe wall. ·5 Test method
5.1 Specification measurement
The inner diameter of the blood transfusion hose is measured with a vernier caliper accurate to 0.02mm, and the wall thickness is measured with a dry ruler with a specification of 0~25mm and an accuracy of 0.01mm. When measuring wall thickness, average the values ??measured along the pipe axis three times. For arbitration tests, measure by opening the pipe from the axis if necessary. 5.2 Appearance quality inspection
4
GB4491-93
Place the blood transfusion hose 20cm above the 20W fluorescent lamp to visually inspect the appearance quality of the hose. The transparency check is based on the ability to clearly see the red paint mark 1mm wide close to the pipe wall through the two-layer pipe wall. 5.3 Physical property test
5.3.1 Sample preparation
Use the same batch of blood transfusion hose production rubber materials and processes to prepare a sample with a thickness of about 1.5mm. The sample must be flat and meet the requirements of 4.8. 5.3.2 Test steps
Take the sample produced by the above method, cut it into a test piece with an I-type cutter, and test it according to the methods specified in HG/T2198, GB/T528, and GB/T3512. Aging conditions (70±2℃)×(166±2h), or (100±2℃)×(22±0.3h). The arbitration test is (70±2℃)×(166±2h).
5.3.3 Cooking test
Cook according to the requirements in GB/T14831, the steam pressure is 0.10MPa, and the time is 30min. 5.4 Clarity test of blood transfusion hose flushing fluid
Use a clarity meter to measure the flushing fluid prepared according to Appendix A. Illuminance 1000～20011x, observation time limit 15s. Or observe under 20W fluorescent lamp and black and white surface conditions.
5.5 Transfusion hose flushing solution pH difference test
Use an acidometer to measure the pH difference between the flushing solution prepared according to Appendix A and the sodium chloride injection before flushing. 5.6 Chemical test methods for blood transfusion hose leakage 5.6.1 Preparation of leachate
Prepare according to Appendix B.
5.6.2 Reagents and standard solutions
5.6.2.1 Reagents are of analytical grade unless otherwise specified. 5.6.2.2 Standard solutions and test preparations are prepared according to GB601 and GB603. 5.6.2.3 The following test solutions are prepared according to the Pharmacopoeia:
a.5% barium chloride test solution (page 97 of the first appendix of the Pharmacopoeia); b. Sodium hydroxide test solution (Pharmacopoeia Part 1, Appendix 95); Sodium sulfide test solution (Pharmacopoeia Part 1, Appendix 96). c.
5.6.2.4 Other test solution preparation methods:
a. Ammonium violacetate indicator: Precisely weigh 75 mg of ammonium violacetate and dissolve it in 50 mL of ethylene glycol, and store it in a brown bottle. b. Potassium carbonate buffer solution: Weigh 69g of potassium carbonate and 1g of potassium bicarbonate, dissolve in distilled water, and dilute to 100mL. 5.6.3 Determination of sulfur
Take 20.0 mL of the leach solution and heat it in a small beaker, evaporate to near dryness, add 1 mL of concentrated nitric acid, and cool to room temperature. Add 0.5 mL of concentrated bromine water, cover with a watch glass, and place in a fume hood overnight. After evaporating to almost dryness on a water bath, add hot distilled water to dissolve (if necessary, use low heat to dissolve), then move it into the Nessler colorimetric tube (A), and in the Nessler colorimetric tube (B), add 9 ml of standard potassium sulfate solution containing 0.033 mg of sulfur per ml, add 5 ml of c (HCl) - 1 mol/L hydrochloric acid and 5 ml of 5% barium chloride test solution to tubes A and B respectively, dilute to 50 ml with distilled water, shake well, and leave for 10 minutes . The turbidity of tube A shall not be deeper than that of tube B. 5.6.4 Determination of arsenic
Take 2.0 mL of the leachate, add 21 mL of distilled water and 5 mL of hydrochloric acid, and conduct the test according to the first method "Arsenic Salt Test Method" in the appendix of the "Pharmacopoeia of the People's Republic of China" (1990 edition) . The color of the specimen stains shall not be darker than the standard arsenic stains. 5.6.5 Determination of zinc
Take 0.5 mL of the leachate and the standard zinc solution containing 0.001 mg of zinc per ml of solution 1.5mL, placed in Nessler colorimetric tubes A and B respectively, add 6mL of distilled water to tube A, add 5mL of distilled water to tube B, add 2 drops of potassium carbonate buffer to each tube, 1mL of 0.001% disulfide trichloromethane, chloroform 5mL, shake for 3 to 5 minutes and look at it with your eyes. The color of the chloroform layer in tube A should not be darker than that in tube B. 5.6.6 Determination of heavy metals
5
GB 4491-93
Take two 25mL Nessler colorimetric tubes, add 10.0mL of the leach solution into tube A, and take another ml of lead. Add 10.0 mL of standard lead solution of 0.001 mg into tube B, and measure according to the third method of "Heavy Metal Inspection Method" in the appendix of "Pharmacopoeia of the People's Republic of China" (Part I of the 1990 edition).
5.6.7 Determination of Calcium| |tt|| Take 25.OmL of the leach solution into an Erlenmeyer flask, add 5mL of c (NaOH) = 0.2mol/L sodium hydroxide solution and 0.5mL of ammonium violacetate indicator, shake well, and use a 2mL microburette to adjust the concentration c (EDTA) = 0.005mol/L EDTA standard solution is titrated until the test solution changes from red to blue-violet as the end point. Calculate the calcium content according to the following formula:
1000
-1 600V.c.
Calcium content 10-6(m/m)=Vc×40×
25
where.V—the volume consumed by the EDTA standard solution during titration, mL; EDTA standard Concentration of the solution, mol/L
5.6.8 Determination of lock
Take 5.0 mL of the leach solution into a test tube, add 2 drops of a saturated solution of chemically pure ammonium sulfate, shake the hook, and leave the solution for 5 minutes. The solution should not be turbid. . 5.7 Blood transfusion hose biological testing method
5.7.1 The leachate for blood transfusion hose biological testing is prepared according to Appendix B. 5.7.2 Abnormal toxicity test
According to the second appendix of the 1990 edition of the Pharmacopoeia of the People's Republic of China. 5.7.3 Pyrogen test method
According to the provisions in the second appendix of the 1990 edition of the "Pharmacopoeia of the People's Republic of China" 5.7.4 Hemolysis test
According to WS1-C6-. 0002. 6 Acceptance Rules
6.1 The manufacturer or purchaser shall organize batches of blood transfusion hoses to be inspected in accordance with this standard. The unit product specified in this standard is a 1m long hose. 6.2 The specifications and dimensions of each batch of blood transfusion hoses. , Appearance and physical properties shall be randomly inspected according to GB2828. The inspection level and AQL value shall comply with the requirements of Table 4.
6.3 Chemical inspection, clarity, pH value difference inspection and cooking test shall be conducted no less than once a month. If one of the test results is unqualified, the item can be retested once and the batch is deemed to be unqualified. Table 4
AQL value
1| |tt||2
3
item
item
specifications and dimensions
appearance
physical properties (before and after aging)||tt ||Check level
S-2
S-4
S-2
Premium product
2.5
2.5||tt ||4.0 | If it is unqualified, the batch is a failed batch. When there are major changes in formulas and process conditions, tests must be conducted at any time. 6.5 The batch size of specifications, dimensions and appearance inspection are determined according to the production scale, and sampling is carried out in accordance with GB2828. 6 | The packaged box (bag) is packed in a strong outer packaging, and the gross weight does not exceed 25kg.
7.2 When packaging blood transfusion hoses, there should be no more than 7 joints per 20m, and no more than 2 short tubes of 400~800mm. 7.3 Each inner package of blood transfusion hoses should be marked with the product standard number, product name, registration number, specifications, quantity, manufacturer name, registered trademark, production batch number, inspector number, user manual and qualification mark. 7.4 The outer packaging of the blood transfusion hose should be marked with the product label number, registration number, product name, specifications, quantity, manufacturer name, trademark, production batch number, volume and weight.
7.5 If there are special requirements for packaging and marking, they can be carried out according to the agreement between the supplier and the buyer. 7.6 Blood transfusion hoses should be covered during transportation and should not be exposed to moisture or heat. They should be stored in a well-ventilated, cool and dry warehouse with a temperature below 35°C and a relative humidity below 80%.
7.7 The product should be stored on a shelf more than 20cm above the ground and 1m away from the heat source. It should not come into contact with oil, acid and alkali, copper, manganese and other harmful substances that affect rubber and the human body.
7.8 Under the storage conditions specified in this standard, blood transfusion hoses shall meet all technical requirements except physical properties within 18 months from the date of manufacture. | |tt | Boil the sodium hydroxide solution in a container for 30 minutes (the hose should be filled with this solution). After cooling, take out the rubbing hose and rinse it with water until the rinse liquid becomes neutral. For the clarity test, rinse with sterile water for injection until there is no foreign matter in the rinse solution; for the pH difference test, rinse with distilled water three times. Dry it and put it into an aluminum box, and cook it with saturated steam at 0.1MPa×30min. After taking it out and letting it cool, use sterile water for injection for the clarity test and sodium chloride injection for the pH value difference test. The water for injection used in both tests passes through the hose at a constant speed within 100 mL × 10 minutes, and the rinse liquid is collected in a beaker. Appendix B
Preparation of overflow liquid
(supplement)
Immerse a 1m long rubber hose sample in a container containing 0.5% sodium hydroxide solution and boil it for 30 minutes (hose should be filled with this solution). After it is slightly cold, rub the hose in the solution, rinse the solution with water (it is basically neutral when tested with pH test paper), then soak it in distilled water for 10 minutes, cut it into 1cm long pieces and put it into a clean Erlenmeyer flask, and rinse it three times with distilled water. After that, add a certain amount of distilled water (based on the hose area of ??100cm2 plus 60mL water), cover the bottle mouth with surface blood, then tie the mouth with double-layer cellophane and four-layer gauze that have just been boiled by distilled water, and cook with saturated steam 0.iMPa×30min. , take it out and let it cool, and then use it for all chemical tests of this standard. The leach solution for biological testing is prepared with sodium chloride injection. | |tt | cm;
L
D--outer diameter of blood transfusion hose, cm,
d--inner diameter of blood transfusion hose, cm.
Additional notes:
This standard was 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 Guilin Latex Factory. The main drafters of this standard are Liu Bin, Yu Guoguang, Shen Huijuan and Zhao Chunhua. (B1)
This standard refers to the American Society for Testing and Materials standard ASTMD3579--1977 (88) "Standard Specification for Shadow Ross Type Surgical Rubber Catheters."
8
V—the volume consumed by the EDTA standard solution during titration, mL; the concentration of the EDTA standard solution, mol/L
5.6.8 Determination of lock
Take 5.0mL of the leachate into the test tube, and add chemical pure Shake the hook with 2 drops of saturated solution of ammonium sulfate. The solution should not be turbid after standing for 5 minutes. 5.7 Blood Transfusion Hose Biological Test Method
5.7.1 The leach solution for the blood transfusion hose biological test is prepared according to Appendix B. 5.7.2 Abnormal toxicity test
shall be carried out in accordance with the provisions in the appendix of the second part of the 1990 edition of the Pharmacopoeia of the People's Republic of China. 5.7.3 Pyrogen inspection method
shall be carried out in accordance with the provisions in the Appendix of Part II of the 1990 edition of the Pharmacopoeia of the People's Republic of China. 5.7.4 Hemolysis test
shall be carried out according to the method specified in WS1-C6-0002. 6 Acceptance rules
6.1 Blood transfusion hoses should be inspected in batches by the manufacturer or the purchaser in accordance with this standard. This standard stipulates that the unit product is a hose with a length of 1m. 6.2 The specifications, dimensions, appearance, and physical properties of each batch of blood transfusion hoses shall be randomly inspected in accordance with GB2828. The inspection level and AQL value should comply with the requirements in Table 4.
6.3 Chemical inspection, clarity, pH difference inspection and cooking test of blood transfusion hoses, no less than once a month. If one of the test results fails, the test can be retested. If the batch is still unqualified, the batch will be deemed unqualified. Table 4
AQL value
order
1
2
3
item
item
Specifications and dimensions
Appearance
Physical properties (before and after aging)
Inspection level
S-2
S-4
S-2
Premium product
2.5
2.5
4.0
Qualified product
4.0
4.0
4.0
6.4 Biological testing of blood transfusion hoses, a batch will be randomly selected for testing every six months. If it is unqualified, the batch is a failed batch. When there are major changes in formulas and process conditions, tests must be conducted at any time. 6.5 The batch size of specifications, dimensions and appearance inspection are determined according to the production scale, and sampling is carried out in accordance with GB2828. 6 | The packaged box (bag) is packed in a strong outer packaging, and the gross weight does not exceed 25kg.
7.2 When packaging blood transfusion hoses, there should be no more than 7 joints per 20m, and no more than 2 short tubes of 400~800mm. 7.3 Each inner package of blood transfusion hoses should be marked with the product standard number, product name, registration number, specifications, quantity, manufacturer name, registered trademark, production batch number, inspector number, user manual and qualification mark. 7.4 The outer packaging of the blood transfusion hose should be marked with the product label number, registration number, product name, specifications, quantity, manufacturer name, trademark, production batch number, volume and weight.
7.5 If there are special requirements for packaging and marking, they can be carried out according to the agreement between the supplier and the buyer. 7.6 Blood transfusion hoses should be covered during transportation and should not be exposed to moisture or heat. They should be stored in a well-ventilated, cool and dry warehouse with a temperature below 35°C and a relative humidity below 80%.
7.7 The product should be stored on a shelf more than 20cm above the ground and 1m away from the heat source. It should not come into contact with oil, acid and alkali, copper, manganese and other harmful substances that affect rubber and the human body.
7.8 Under the storage conditions specified in this standard, blood transfusion hoses shall meet all technical requirements except physical properties within 18 months from the date of manufacture. | |tt | Boil sodium hydroxide solution in a container for 30 minutes (the hose should be filled with this solution). After cooling, take out the rubbing hose and rinse it with water until the rinse liquid becomes neutral. For the clarity test, rinse with sterile water for injection until there is no foreign matter in the rinse solution; for the pH difference test, rinse with distilled water three times. Dry it and put it into an aluminum box, and cook it with saturated steam at 0.1MPa×30min. After taking it out and letting it cool, use sterile water for injection for the clarity test and sodium chloride injection for the pH value difference test. The water for injection used in both tests passes through the hose at a constant speed within 100 mL × 10 minutes, and the rinse liquid is collected in a beaker. Appendix B
Preparation of overflow liquid
(supplement)
Immerse a 1m long rubber hose sample in a container containing 0.5% sodium hydroxide solution and boil it for 30 minutes (hose should be filled with this solution). After it is slightly cold, rub the hose in the solution, rinse the solution with water (it is basically neutral when tested with pH test paper), then soak it in distilled water for 10 minutes, cut it into 1cm long pieces and put it into a clean Erlenmeyer flask, and rinse it three times with distilled water. After that, add a certain amount of distilled water (based on the hose area of ??100cm2 plus 60mL water), cover the bottle mouth with surface blood, then tie the mouth with double-layer cellophane and four-layer gauze that have just been boiled by distilled water, and cook with saturated steam 0.iMPa×30min. , take it out and let it cool, and then use it for all chemical tests of this standard. The leach solution for biological testing is prepared with sodium chloride injection. | |tt | cm;
L
D--outer diameter of blood transfusion hose, cm,
d--inner diameter of blood transfusion hose, cm.
Additional notes:
This standard was 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 Guilin Latex Factory. The main drafters of this standard are Liu Bin, Yu Guoguang, Shen Huijuan and Zhao Chunhua. (B1)
This standard refers to the American Society for Testing and Materials standard ASTMD3579--1977 (88) "Standard Specification for Shadow Rose Type Surgical Rubber Catheters."
8
V—the volume consumed by the EDTA standard solution during titration, mL; the concentration of the EDTA standard solution, mol/L
5.6.8 Determination of lock
Take 5.0mL of the leachate into the test tube, and add chemical pure Shake the hook with 2 drops of saturated solution of ammonium sulfate. The solution should not be turbid after standing for 5 minutes. 5.7 Blood Transfusion Hose Biological Test Method
5.7.1 The leach solution for the blood transfusion hose biological test is prepared according to Appendix B. 5.7.2 Abnormal toxicity test
shall be carried out in accordance with the provisions in the appendix of the second part of the 1990 edition of the Pharmacopoeia of the People's Republic of China. 5.7.3 Pyrogen inspection method
shall be carried out in accordance with the provisions in the Appendix of Part II of the 1990 edition of the Pharmacopoeia of the People's Republic of China. 5.7.4 Hemolysis test
shall be carried out according to the method specified in WS1-C6-0002. 6 Acceptance rules
6.1 Blood transfusion hoses should be inspected in batches by the manufacturer or the purchaser in accordance with this standard. This standard stipulates that the unit product is a hose with a length of 1m. 6.2 The specifications, dimensions, appearance, and physical properties of each batch of blood transfusion hoses shall be randomly inspected in accordance with GB2828. The inspection level and AQL value should comply with the requirements in Table 4.
6.3 Chemical inspection, clarity, pH difference inspection and cooking test of blood transfusion hoses, no less than once a month. If one of the test results fails, the test can be retested. If the batch is still unqualified, the batch will be deemed unqualified. Table 4
AQL value
order
1
2
3
item
item
Specifications and dimensions
Appearance
Physical properties (before and after aging)
Inspection level
S-2
S-4
S-2
Premium product
2.5
2.5
4.0
Qualified product
4.0
4.0
4.0
6.4 Biological testing of blood transfusion hoses, a batch will be randomly selected for testing every six months. If it is unqualified, the batch is a failed batch. When there are major changes in formulas and process conditions, tests must be conducted at any time. 6.5 The batch size of specifications, dimensions and appearance inspection are determined according to the production scale, and sampling is carried out in accordance with GB2828. 6 | The packaged box (bag) is packed in a strong outer packaging, and the gross weight does not exceed 25kg.
7.2 When packaging blood transfusion hoses, there should be no more than 7 joints per 20m, and no more than 2 short tubes of 400~800mm. 7.3 Each inner package of blood transfusion hoses should be marked with the product standard number, product name, registration number, specifications, quantity, manufacturer name, registered trademark, production batch number, inspector number, user manual and qualification mark. 7.4 The outer packaging of the blood transfusion hose should be marked with the product label number, registration number, product name, specifications, quantity, manufacturer name, trademark, production batch number, volume and weight.
7.5 If there are special requirements for packaging and marking, they can be carried out according to the agreement between the supplier and the buyer. 7.6 Blood transfusion hoses should be covered during transportation and should not be exposed to moisture or heat. They should be stored in a well-ventilated, cool and dry warehouse with a temperature below 35°C and a relative humidity below 80%.
7.7 The product should be stored on a shelf more than 20cm above the ground and 1m away from the heat source. It should not come into contact with oil, acid and alkali, copper, manganese and other harmful substances that affect rubber and the human body.
7.8 Under the storage conditions specified in this standard, blood transfusion hoses shall meet all technical requirements except physical properties within 18 months from the date of manufacture. | |tt | Boil the sodium hydroxide solution in a container for 30 minutes (the hose should be filled with this solution). After cooling, take out the rubbing hose and rinse it with water until the rinse liquid becomes neutral. For the clarity test, rinse with sterile water for injection until there is no foreign matter in the rinse solution; for the pH difference test, rinse with distilled water three times. Dry it and put it into an aluminum box, and cook it with saturated steam at 0.1MPa×30min. After taking it out and letting it cool, use sterile water for injection for the clarity test and sodium chloride injection for the pH difference test. The water for injection used in both tests passes through the hose at a constant speed within 100 mL × 10 minutes, and the rinse liquid is collected in a beaker. Appendix B
Preparation of overflow liquid
(supplement)
Immerse a 1m long rubber hose sample in a container containing 0.5% sodium hydroxide solution and boil it for 30 minutes (hose should be filled with this solution). After it is slightly cold, rub the hose in the solution, rinse the solution with water (it is basically neutral when tested with pH test paper), then soak it in distilled water for 10 minutes, cut it into 1cm long pieces and put it into a clean Erlenmeyer flask, and rinse it three times with distilled water. After that, add a certain amount of distilled water (based on the hose area of ??100cm2 plus 60mL water), cover the bottle mouth with surface blood, then tie the mouth with double-layer cellophane and four-layer gauze that have just been boiled by distilled water, and cook with saturated steam 0.iMPa×30min. , take it out and let it cool, and then use it for all chemical tests of this standard. The leach solution for biological testing is prepared with sodium chloride injection. | |tt | cm;
L
D--outer diameter of blood transfusion hose, cm,
d--inner diameter of blood transfusion hose, cm.
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 Latex Industry Research Institute of the Ministry of Chemical Industry. This standard is drafted by Guilin Latex Factory. The main drafters of this standard are Liu Bin, Yu Guoguang, Shen Huijuan and Zhao Chunhua. (B1)
This standard refers to the American Society for Testing and Materials standard ASTMD3579--1977 (88) "Standard Specification for Shadow Rose Type Surgical Rubber Catheters."
8
4. The outer packaging of the blood transfusion hose should be marked with the product label number, registration number, product name, specifications, quantity, manufacturer name, trademark, production batch number, volume and weight.
7.5 If there are special requirements for packaging and marking, they can be carried out according to the agreement between the supplier and the buyer. 7.6 Blood transfusion hoses should be covered during transportation and should not be exposed to moisture or heat. They should be stored in a well-ventilated, cool and dry warehouse with a temperature below 35°C and a relative humidity below 80%.
7.7 The product should be stored on a shelf more than 20cm above the ground and 1m away from the heat source. It should not come into contact with oil, acid and alkali, copper, manganese and other harmful substances that affect rubber and the human body.
7.8 Under the storage conditions specified in this standard, blood transfusion hoses shall meet all technical requirements except physical properties within 18 months from the date of manufacture. | |tt | Boil the sodium hydroxide solution in a container for 30 minutes (the hose should be filled with this solution). After cooling, take out the rubbing hose and rinse it with water until the rinse liquid becomes neutral. For the clarity test, rinse with sterile water for injection until there is no foreign matter in the rinse solution; for the pH difference test, rinse with distilled water three times. Dry it and put it into an aluminum box, and cook it with saturated steam at 0.1MPa×30min. After taking it out and letting it cool, use sterile water for injection for the clarity test and sodium chloride injection for the pH value difference test. The water for injection used in both tests passes through the hose at a constant speed within 100 mL × 10 minutes, and the rinse liquid is collected in a beaker. Appendix B
Preparation of overflow liquid
(supplement)
Immerse a 1m long rubber hose sample in a container containing 0.5% sodium hydroxide solution and boil it for 30 minutes (hose should be filled with this solution). After it is slightly cold, rub the hose in the solution, rinse the solution with water (it is basically neutral when tested with pH test paper), then soak it in distilled water for 10 minutes, cut it into 1cm long pieces and put it into a clean Erlenmeyer flask, and rinse it three times with distilled water. After that, add a certain amount of distilled water (based on the hose area of ??100cm2 plus 60mL water), cover the bottle mouth with surface blood, then tie the mouth with double-layer cellophane and four-layer gauze that have just been boiled by distilled water, and cook with saturated steam 0.iMPa×30min. , take it out and let it cool, and then use it for all chemical tests of this standard. The leach solution for biological testing is prepared with sodium chloride injection. | |tt | cm;
L
D--outer diameter of blood transfusion hose, cm,
d--inner diameter of blood transfusion hose, cm.
Additional notes:
This standard was 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 Guilin Latex Factory. The main drafters of this standard are Liu Bin, Yu Guoguang, Shen Huijuan and Zhao Chunhua. (B1)
This standard refers to the American Society for Testing and Materials standard ASTMD3579--1977 (88) "Standard Specification for Shadow Ross Type Surgical Rubber Catheters."
8
4. The outer packaging of the blood transfusion hose should be marked with the product label number, registration number, product name, specifications, quantity, manufacturer name, trademark, production batch number, volume and weight.
7.5 If there are special requirements for packaging and marking, they can be carried out according to the agreement between the supplier and the buyer. 7.6 Blood transfusion hoses should be covered during transportation and should not be exposed to moisture or heat. They should be stored in a well-ventilated, cool and dry warehouse with a temperature below 35°C and a relative humidity below 80%.
7.7 The product should be stored on a shelf more than 20cm above the ground and 1m away from the heat source. It should not come into contact with oil, acid and alkali, copper, manganese and other harmful substances that affect rubber and the human body.
7.8 Under the storage conditions specified in this standard, blood transfusion hoses shall meet all technical requirements except physical properties within 18 months from the date of manufacture. | |tt | Boil the sodium hydroxide solution in a container for 30 minutes (the hose should be filled with this solution). After cooling, take out the rubbing hose and rinse it with water until the rinse liquid becomes neutral. For the clarity test, rinse with sterile water for injection until there is no foreign matter in the rinse solution; for the pH difference test, rinse with distilled water three times. Dry it and put it into an aluminum box, and cook it with saturated steam at 0.1MPa×30min. After taking it out and letting it cool, use sterile water for injection for the clarity test and sodium chloride injection for the pH value difference test. The water for injection used in both tests passes through the hose at a constant speed within 100 mL × 10 minutes, and the rinse liquid is collected in a beaker. Appendix B
Preparation of overflow liquid
(supplement)
Immerse a 1m long rubber hose sample in a container containing 0.5% sodium hydroxide solution and boil it for 30 minutes (hose should be filled with this solution). After it is slightly cold, rub the hose in the solution, rinse the solution with water (it is basically neutral when tested with pH test paper), then soak it in distilled water for 10 minutes, cut it into 1cm long pieces and put it into a clean Erlenmeyer flask, and rinse it three times with distilled water. After that, add a certain amount of distilled water (based on the hose area of ??100cm2 plus 60mL water), cover the bottle mouth with surface blood, then tie the mouth with double-layer cellophane and four-layer gauze that have just been boiled by distilled water, and cook with saturated steam 0.iMPa×30min. , take it out and let it cool, and then use it for all chemical tests of this standard. The leach solution for biological testing is prepared with sodium chloride injection. | |tt | cm;
L
D--outer diameter of blood transfusion hose, cm,
d--inner diameter of blood transfusion hose, cm.
Additional notes:
This standard was 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 Guilin Latex Factory. The main drafters of this standard are Liu Bin, Yu Guoguang, Shen Huijuan and Zhao Chunhua. (B1)
This standard refers to the American Society for Testing and Materials standard ASTMD3579--1977 (88) "Standard Specification for Shadow Ross Type Surgical Rubber Catheters."
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