GB 19335-2003 General technical requirements for single-use blood circuit products

This standard specifies the general technical conditions for disposable blood circuit products. This standard applies to products composed of blood circuits made of polyvinyl chloride as the main material and its associated pipelines, including liquid circuits and pressure monitoring pipelines. The relevant provisions in the product standards take precedence over this standard. GB 19335-2003 General Technical Conditions for Disposable Blood Circuit Products GB19335-2003 Standard Download Decompression Password: www.bzxz.net

ICS11.040.2C
National Standard of the People's Republic of China
GB19335—2003
Blond flow products for single use
General technical conditions
Specification2003-10-20 Issued
Shandong People's Republic of China
General Administration of Quality Supervision, Inspection and Quarantine
2004-04-01 Implementation
The technical content of this standard mainly refers to the international standards for single-use blood infusion sets and related products:
GH19335-2003
Part 4: Single-use blood infusion sets
11998-1098 Single-use blood infusion products. General technical conditions 3. This standard replaces the Appendix A, Appendix B, Appendix D, Appendix F and Appendix F of the standard YY03I1
YY0311-1098
. This standard is proposed by the National Food and Drug Administration to put forward the technical requirements for the standardization of single-use infusion sets. This standard is from the National Product Supervision and Inspection Center of Medical Devices. The main drafters of this standard: Runhua, Luo Hongzi, Zhu Xin, Mei Ping, Sun Guangyu 1. General technical conditions for disposable blood circuit products. This standard specifies the general technical conditions for disposable blood circuit products. CB19335—2003
This standard applies to the products made of polyvinyl chloride as the main material and its integrated auxiliary pipelines, including blood circuits and pressure monitoring pipelines (hereinafter referred to as "blood circuits"). The relevant provisions in the product standards take precedence over this standard. 2. Normative reference documents
Many of the items in the underlined documents have become the references of this standard through the six standards. For the reference documents of the same period, all subsequent interpretations or statements (excluding the contents of the reference documents) are not applicable to this standard. However, the latest versions of these documents shall be used according to the requirements of this standard. For the safety equipment of the same period, the latest versions shall apply to this standard. GB/192 (all parts) Syringes, injection devices and other medical equipment (G14233.1998) Test methods for injection devices - Part 1: Chemical analysis methods B/T14233.2 Medical specifications for injection devices, light Blood (liquid) devices and their test methods Part 2: Biological test methods (G15593 Blood (liquid) devices and their soft fluorine-impregnated plastics GB1582 Disposable large-scale radiometers
B16.1 Medical devices will be evaluated biologically: Part 1 Evaluation and testing will be YY/3_3 Medical polymer products Packaging, marking, transportation and storage 3 Requirements
3.1 Materials
New materials used in direct or indirect connection with blood should meet the requirements of 155 heat screening, 3.2 Physical properties
3.2.1 Contains
Blood path Seal each end 11, immerse in 20 ~ 3W% water, pass through 50kPa higher than atmospheric pressure or the maximum working pressure specified by the manufacturer, and pressurize for 2 minutes. There should be no signs. If there are special requirements, the blood circuit should be determined according to the specific situation. 3.2.2 Connection firmness
Each connection (excluding the probe) should be able to withstand a single axial tensile force of 15V and should not break or fall off for 15s. 3.2.3 Protective sleeve
The protection of each product should be firm and keep the interior free of defects and easy to damage. 3.2.4 Micro content
When the amount of micro-particles produced by the point road is small, the equivalent method of the appendix is ​​used to determine the number of particles. The number of particles per square meter of surface area of ​​15-2 is not qualified. The number of particles greater than 75% shall not exceed 1. 3.2.5 Notes
1 If there are injections on the road, it is required to bring more than one drop of fresh blood on time. 3.2.6 Color mark
When the blood circuit is divided into arterial blood circuit and venous blood circuit, there shall be obvious color markings within 10oIr1 of the end of the circuit. The arterial blood circuit should be red and the venous blood circuit should be vegetable color.
CB 19335—2003
3.2.76% Luer surround connector
6% Luer cone connector between blood circuits should be required as (1582, 3.2.8 Blood filter
The mesh size of the blood filter and blood line decompression filter on the blood circuit should be uniform, the effective flow area should be not less than 10m, and its filtration rate should not be less than that of other filters during the test.
3.2.9 Switch
3.2.9.1 The contact type renal clamp or flow regulator should be used as the switch of the blood circuit in priority, and its speed should be reliable. 3.2.9.2 There should be a clear indication of the closed state on the contact blood circuit switch (blood single-pass switch, four-pass switch, one-network five-way T switch, etc.). Its performance should be reliable: 3.2.10 Air filter
If there is an air intake on the blood circulation path, it should be equipped with an air filter that can prevent foreign micro-particles and dust from entering the blood circulation path. When tested according to the Appendix, the air filter should have a filtration rate of at least 0.5% of the ultraviolet particles in the air. 3.2.11 Appearance
The surface of the blood circulation path should be plasticized and uniform without any agglomeration, and its brightness should be able to detect the pool of blood with normal vision or corrected vision: 3.3 Chemical propertiesbZxz.net
The test sample prepared according to Appendix E should meet the requirements of 3.1 to 3.3.6. 3.3.1 Color
The test sample should be colorless and transparent when tested with normal vision or corrected vision. 3.3.2 Reducing substances
According to 5.2.2 of GR/T14733.1-19DX, when testing, the volume ratio of potassium permanganate filtered through the test filter and the blank solution shall not exceed 2.9m/s.
3.3.3 Metal ions
According to 5.9.1 of GR/T14733.1-1998, when testing by atomic absorption spectrometry (AAS), the total content of metal ions shall not exceed 1//mL, and the content of metal ions shall not exceed 1//mL. According to 5.6 of GB/T11233.1-1905, when testing, the content of metal ions present shall not exceed the standard value of P(15-)=1g/mL.
According to G/T11233.1-1995, 1.1, when testing, the test sample shall be compared with the blank sample of the same batch, and the pH value difference shall not exceed 5.5. 3.3.5 Evaporation
According to GB/T-1244.1-1958, 5, when testing, the total amount of non-volatile matter in 50ml of test solution shall not exceed 2mg. 3.3.6 Absorbance
According to B/T14223.1-1998, 5.7, when testing, the absorbance of the test solution in the range of 25nm~320nm shall not be greater than 1. 3.4 Splash of ethylene oxide
When the inspection is carried out according to the method in Appendix F, the ethylene oxide splash on the blood path shall meet the requirements specified in the product standard. 3.5 Biological performance
3.5.1 General
Biological evaluation shall be carried out according to (K/1E886.1), and any substance that may cause harm to the human body shall not be released or discharged. 3.5.2 Sterility
The inner package shall be sterilized by a sterilization process: Note: For the most appropriate method, see An Xiao,
2: H/T 14233.2, the method for identifying bacteria is specified, but this method is not used for white factory testing, 2
3.5.3 Heat irradiation
GB 19335—2003
Apply appropriate tests to evaluate the pyrogenicity of blood products. The results should show that the blood products are pyrogenic. "5/114239.2 gives the pyrogenicity test method.
3.5.4 Bacterial endotoxin
The product should control the bacterial endotoxin content in the corresponding product label. GB/T14233.2 gives the method for bacterial endotoxin test.
3.5.5 Passive blood
When tested according to GB/T14233.2, the blood drop rate should not exceed 5%. 4 Packaging and labeling
The packaging and labeling of blood products should comply with the YY/051a standard. Requirements, GB19335-2003
A1 Principle
Appendix A
(Normative Appendix)
Batch Particle Damage Disk Test Method
This method is to evaluate the flushing contamination by flushing the blood path cavity full body channel surface back, collecting channel: the surface flushing batch of particles, and counting them:
A.2 Test Receiver
4.2.1 Special Effective Particle Counter: There is a system, the sampling disk is JL, which can be used for 5m~·2m and large ten 2HE particles.
2.2 Flushing liquid, matching particle counter requirements, new 0.45 beats of micronized filtration. A.3 Steps
Note: Avoid purging.
A.3.1 Preparation of the selected elution solution
Use a flushing limit of 1 mL per square meter of internal surface area of ​​the blood path: The method should be designed so that all blood paths that are directly or indirectly in contact with blood or blood components can flow through the same amount of elution concentrate per unit area (if there is a blood path, the density of flushing of this part should be increased accordingly). The effluent flows into a clean filter to obtain the total elution solution. A.3.2 Particle test
Take the elution filter) ... A.4 Expression of results
The counter count divided by 1 is the particle content, the unit is particles per liter, air correction: Appendix
(normative)
Test method for self-sealing of injection parts
GH19335-203
The injection parts are horizontal and not subjected to force. The blood path is filled with water to avoid contamination with bubbles. A pressure higher than the atmospheric pressure of 20 kPa (290 mbar) is passed through. The injection parts are tested with a pressure of 20 kPa (290 mbar) higher than the atmospheric pressure. The injection needle with a diameter of 0.mm is used for puncture. The injection area is penetrated by the injection device. After 15s, the injection needle is pulled out and the puncture site is quickly dried. Observe whether there is leakage within 1min: If the injection device has any abnormal design or modification, the puncture injection device shall be tested according to the basic control method provided by the manufacturer. 5
GI193352003
Heart.1 Health
(Normative Attachment)
Blood violation and blood filtration and efficiency test method must be used! The reserve working liquid that has passed the test can flow through the test filter and the standard filter. Solution: The quality of the two filters is: If the pores of the material meet the requirements of the standard filter (Section 1), it is exempt from the sugar removal test. C.2 Standard filter || tt || The standard filter should be woven from 6-6 monofilaments, with a monofilament diameter of 100m ± 10Tm, a single warp, and a pore size of 200m-20 F.
Inlet:
2--Standard Filter
Fixed Loading Through the Net:
The wine at the entrance of the bucket
Figure C.1 Standard bucket separation component
The same type of 40 blood type human whole blood prepared for anti-birth, the film is passed for not less than 2 weeks, and is injected into the container 1 through a 325m aperture through the discharge net, and the short is fully mixed. Let the positive pressure in the container flow through IT under the action of the pressure, so that the mystery on the filter Excess blood is drained off, and the filter material is placed in an oven at 0.6 = ki (6.5 mbar) to the basic requirements: L.3.1 Method 4 (for filter materials)
Cut two surface materials with a diameter of 4m from the standard filter material and the fast test material: During the test, fix the material 6
with the rise method to the test device that can make the entire surface of the filter material covered by the main residual benefit. C.3.2 Method H (for filter components) | |tt||GB19335—2003
The standard filter assembly shall have a standard filter material with an opening at one end and an area of ​​122 m1. The filter material shall be placed in the filter with an outlet at the bottom. The outlet of the filter shall have a standard drop of 20 drops of distilled water per m1. The inlet pipe shall extend into the filter. C.1 indicates the appropriate standard filter components. The test steps are the same as those in Chapter 3. Note: Method A and Method D are optional.
C.4 indicates
The mass of the substance removed by the test filter (material) relative to the standard filter (material) is given by the formula (mn-100%):
The mass of the test filter (material) before the blood passes through the filter, in grams (g); m
The mass of the test filter (material) after the blood passes through the filter, in grams (g); ( 1
GA19335—2003
P,I Test instrument
(Normative appendix)
Test method for air filter removal rate
The length of the small particle filter is 1m, the sampling rate is: times/min, and the rotor flowmeter: the range is 80ml./min or 100ml./tti. D,2 Test steps
Under static environmental conditions, connect the small particle meter to the flow meter, and under the condition of an air flow rate of 50mt./rmin, measure the number of particles above 0.5m in the sampled air within 1min, and read five data continuously. Take the air filter and connect it to the inlet of the flow meter according to the direction of use. Under the corresponding air volume, measure the number of particles above 0.5m in the sudden air flowing through the air filter within 1min, and read five data continuously. Remove the maximum and minimum values ​​from the five data and take the average of the remaining three values. D.3 Result Expression
Formula (1) gives the calculation formula for the data pool, expressed as a percentage, x100%
In the formula:
The air is naturally removed by the filter, which is;
\ The number of particles larger than 0.5 μm in the air;
—- The number of particles larger than 5 μm in the air after passing through the air filter, (D)
Appendix E
Normative Record)
Preparation of Chemical Performance Test Solution
CB19335—2003
E.1 4 m long blood path and individual wunL after absorbing fire chrysanthemum Then press a closed loop system, add 2 mL of water to the flask and promote it at 37°C. Collect all the remaining samples at a flow rate of 1/h and cool them down. Then print the test solution: connect the sample with a batch of water to the deep box, return to the sample, and prepare the concave control E.2. If the sample contains pump energy, it is necessary to follow the conditions of E.1. Prepare the empty control by using a dynamic system directly on the image tube: take a L. Fill the flask with 253 mL of water. Keep the level at 37°C. Place it in the filter for 2 hours.
E.3. If there is a sample station, add a standard amount of water to the sample, and place it at 37°C. Place it in the filter plate with the corresponding effect of 21°C as the test solution. Prepare blank solution according to method E,
F,4 light test solution of the main test solution of the product is combined to form a broad: when it is necessary to evaluate the blood supply of adult fish, the parts of the product can be discarded separately, GR19335-20C3
F.1 Gas chromatograph description (arbitration method)
F.1.1 Principle
Under a certain humidity, use an extractant
F, 1.2 Gas chromatograph conditions
Appendix F
(Normative Appendix)
Circulating weight Ethane Residue Analysis Method
· Determine the ethane content by the peak pressure phase separation method of the ethane in the sample. F.1.2.1 Hydrogen flame chromatogram, sensitivity not less than 12X.0-\a/s (benzene, two-fluid chemical reading), F.1.2.2 Chromatographic column, the chromatographic column used should be able to completely separate the impurities and unsaturated ethane in the sample at a certain point and have a certain time property, the chromatographic properties should be the conditions recommended in Table F.1,
Chromatographic column properties
F.1.2.3 Temperature of the chromatographic column:
. 1.2. 4 Gas flow:
N.13: ni./im30 nr:
I1, 30 m:./rm
air iu m.imir..
F.1.3 Preparation of ethylene dichloride standard stock solution
CDX-JU7BU IUC Division
Fpak yr
120℃
Take about 100 ml of dry liquid and measure carefully to the nearest 3 ml. Use a syringe to measure (ethylene gas, do not add bottle case, after holding the bottle, measure, the first two standard measurements, the actual amount of ethylene contained in the solution, add water to the scale below the liquid to 1%/. as the standard compensation micro-step. I.1.4 Sampling
Test sample preparation: The sample should be taken immediately and sealed in a gold container with a shelf for a period of time. I. 1. 5 Preparation of test cell: 1.5.1 Take a sample with a surface of 5 m long, take 3 g of the sample and place it in a test chamber, add 110 ml of water, and place it in a water bath at a constant pressure of 13 mT. 1.5.2 For the sample, add water to the nominal pressure, and keep the temperature at 37.1.1 for 11: as the test fluid. Take 111 ml of water and place it in a test chamber at a constant pressure of 65°C for 11: F.1.Step E: 1.1.6.1 Prepare a series of concentrations of 1g/ml~10mk/ml of standard solution. Take 1mL of each sensitive solution from the container. Place the container under pressure and place it in constant water. Take 1mJ (or the corresponding volume) of the upper gas from the corresponding sample and record the peak height (or area) of the epoxy resin. Note: When using the same syringe in the same batch, the first and second syringes should not be filled with the same product.
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