Some standard content:
Appendix A, Appendix 1 and Appendix F of this standard are normative appendices, while Appendix C and Appendix D are informative appendices. This standard was proposed by the National Technical Committee for Standardization of Medical Infusion Devices. This standard is under the jurisdiction of the National Product Supervision and Administration Commission. Drafting of this standard: Shangyou Yixin Medical Equipment Co., Ltd. Main drafters of this standard: Luo Ai, Yang Yumin, Hao Ping, YY 0451-2003
YY 0451-2003
Disposable infusion pumps have two infusion power forms: organic elastic and electric drive. In the mechanical elastic form, the infusion pump is made of high-density materials, and the processing technology is relatively simple. It is easy to be non-degradable after clinical use in medical treatment. Therefore, a certain degree of production and clinical use of medical products has been formed in my country. However, the electric drive with relatively high infusion accuracy is still in the development stage in my country due to reasons such as in-house manufacturing. This standard specifies requirements for mechanical elastic force pumps, and is not applicable to delivery systems with other power forms (such as electric drive forms). There are many types of mechanical elastic force pumps. In order to avoid inhibiting innovation, this standard defines the parameters of injection channels according to the needs of clinical use and detection, and classifies new injection methods according to the clinically used delivery methods. The typical basic structure of the infusion system is given. The delivery parameters of the infusion pump are of great clinical significance. In this regard, Appendix B of the standard gives specific testing methods to ensure that the mechanical elastic force infusion pump delivery parameters have been determined during the manufacturing process. Fourth, the Appendix C (Informative Appendix) of this standard lists the infusion delivery parameters. The liquid feeding process control system is constantly changing to improve the product quality.
The test of the liquid feeding parameters mentioned in this standard is carried out under zero reverse pressure. In order to make the experimental data in different regions comparable, the infusion policy can also provide the positive effect of the virtual part of the patient in clinical use, which will make the actual flow rate smaller than the a posteriori obtained volume. In addition, the range of countries is wide, and the difference in pressure is very large. The higher the pressure, the higher the positive effect in actual use, and the smaller the flow rate. To achieve the same flow rate during use, the whole injection system can be appropriately raised. The product has this to say in the instruction manual:
1 Standard
Disposable infusion system
This standard defines the requirements for a disposable injection system powered by elastic force. ，Y0451—2003
This standard is for the use of devices for the administration of micro-injection in clinical micro-injection therapy (which may be equipped with automatic delivery devices, hereinafter referred to as delivery devices).www.bzxz.net
2. Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For any expired referenced documents, all subsequent revisions (excluding those in the revised version) shall not apply to this standard. However, the parties concerned shall reach an agreement with this standard on whether the latest revisions of these documents can be obtained. For any undated references, the latest versions shall still apply. GH/T193.1 Syringes, injections and other medical devices Part 1, General requirements G/T19G2.2 Syringes, injection needles and other medical devices G% (excluding those in the revised version) Cone head Part 2: Locking head GB/T2828 Remote inspection counting sample serial number and oil barrier (applicable to the inspection of re-approval) GB/T14233.1-10 Medical infusion, blood transfusion, injection equipment acceptance: Methods Part 1: Chemical analysis methods (H/T14233.2 Medical infusion, blood transfusion, injection equipment and its inspection methods Part 2: Biological test methods GB/T168Rh1 Medical device biological evaluation Part 1: Evaluation and test YY/T03151993# Packaging, marking, transportation and storage of high-efficiency products 3 Terms and definitions
The following terms and definitions apply to standardization: 3.1
Nominal volume
The nominal volume of light filter that can be injected per time specified by the manufacturer, in liters. 3.2
Nominal flow rate (R)minimum flow rate
The continuous flow rate under normal use conditions indicated by the indicator, in units of hours3.3
Average flow rate (Qu)mean flow rate
The ratio of the effective flow rate of the whole ticket output to the required flow rate. 3.4
Interstitial flow rate (I)input rateThe output of any one station during the process of operation3.5
Effective flow rate (V)feeliviaFuiandw
The total flow rate that can meet the requirements of the intermittent flow during the operation. After this output, it cannot be guaranteed that the total flow rate can be met. 3.6
Automatic slimming device holusmeans
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HI--PCA is a device that allows patients to add additional amounts of medication according to their needs during the continuous infusion process. 3.7 ...bolusdese
B+FCA type injection device records the amount of medication discharged by pressing the self-controlled syringe once, expressed in ml/time. 3.8
Automatic control armpit idle time (fe) Jock-outtim This will be due to the single drag pressure self-book bamboo shoots business according to the chain of the world time drop time, expressed in minutes, 4 classification
4.1 Infusion pump recovery hydraulic type classification is: continuous infusion CI?. Continuous infusion equipment + household controlled infusion (CI + PCA) two types 4.2 Basic auxiliary average, typical drug infusion stop this one-way reading plus two-way installation, membrane force actual combat whole, drug rolling filter travel, test device, automatic control age (called no), kidney circuit and external lithium joints, etc. Note: CB155931995 stipulates the requirements for the use of disk liquid, YY003119 stipulates the requirements for the use of silicone rubber.
5 Physical properties
5.1 Appearance
5.1.1. The outer surface of the juice pump should be free of burrs.
5.1.2 The infusion system should be free of obvious impurities, objects, etc. 5.2 Sealing
Close the outlet, inject 1.1 times the volume of purified water from the inlet, and add 2 times the volume. There should be no leakage, and the stored liquid should not burst. 5.3 Connection firmness
Each part of the liquid channel should be able to withstand a static pumping force of 15V without falling off. 5.4 Temperature range
The liquid should be installed in a transparent protective device with sufficient protection. After adding the standard amount of purified water from the inlet, there should be no obvious swelling. In addition to the requirements of light protection,
5.5 Protection
The infusion outlet should be equipped with a protective sticker, which should not fall off naturally and be easy to remove. 5.6 Switch
If the pipeline has an integral switch, the switch should be able to reliably control the correct flow and smooth flow of the drug. When in use, the pipeline should not be damaged or the inner wall should not be damaged.
5.7 Feedback joint
The infusion terminal should be connected to the outside. The joint should comply with (H/1!62.1 If the standard joint is a fixed joint, it should comply with 6GB/F19% 2.2.5.B The liquid filter device
The infusion should have a drug filter. Attachment A When the drug is tested, the rate of ineffective particles greater than 5 μm in the drug should be less than 10%.
5.9 Pipeline
The pipe should be transparent enough to be transparent so that bubbles can be found. Note: There should be no light. 5.10 The test results shall be in accordance with the requirements of 5.10.1~5.0.3 when tested according to Appendix B. 5.10.1~5.0.3 shall be in accordance with the requirements of Appendix B. 5.10.1 The average flow rate shall be within the nominal flow value (1x15%). 5.10.2 The instantaneous flow rate shall be within the nominal flow value (1x15%). 5.10.3 The automatic control system shall meet the requirements of 5.10.1~5.0.3. 0451--2003
When testing according to Appendix F, the automatic liquid feeding device before the CB1+PCA pump shall meet the requirements of 5.10.3.1 and 5.13.3.2. 5.10.3.1 Automatic liquid feeding dosage
The full volume of the automatic liquid feeding system shall be within the nominal value (V)×(1=15%). 5.10.3.2 Automatic start-up interval
The automatic liquid feeding interval shall be within the nominal value (te×(1+2%). 5.11 Batch particle contamination
Technical requirements E shall be tested. The number of particles with a size of 1:μm~25mm shall not exceed 1.0c/ml. The number of particles with a size of more than 25m shall not exceed 0.50/ml.
6 Chemical properties
6.1 Preparation of test solution
Please fill the pipeline with desensitizing water with the nominal volume of purified water, and keep it at 37℃±13℃ for 2h in a refrigerated room to reduce the flow rate. The test solution should meet the requirements of 0.2~5.6. 6.2 The reducing substance shall be carried out according to the provisions of 6B/T14233.1-19085, 2.2 Method 2. The volume of the test liquid shall be no less than 2.JmL: 6.3 The metal ion shall be carried out according to the provisions of GB/T14233.1-18S8, 5.6. Method 1. The volume of the test liquid shall be no less than 0.1g/mL compared with the standard reference liquid (pH=1g/mL). 6.4 The acid reduction degree shall be carried out according to the provisions of CF/T14233.1-1998, 4.4 Method 1. The difference between the pH value of the test liquid and the pH value of the white liquid shall not exceed 1 yuan. 5.5 The total amount of residual product obtained shall not exceed 2mg according to the provisions of GD/T11233.1-199% for the evaporation of weak slag by heat treatment. 6.6 Ultraviolet absorbance shall be tested in 250m1~22Vrm according to the provisions of GD/T11233.1-199%. The range of ultraviolet absorbance shall be 0.3. 6.7 Epoxy Z burning residue shall be collected from the front of the elastic device at 1% filling injection, and 2.0g of the sample shall be cut from the front of the elastic device, (%/T14253.1-139% according to the provisions of Epoxy I 10/
7 Biological properties
7. 1 General
Infusions should be evaluated biologically in accordance with the requirements of G3/T1688S.1 and should not release any substances that may cause adverse effects on humans. 7.2 Sterile
Infusions should be sterilized through a confirmed sterilization process. Note:
1 For sterile conditions, see reference document.
2 CB:T4233.2193 specifies the sterilization test length as 100 million, which is applicable to the factory.
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7.3 Bacterial endotoxins
According to (:5/11233.2-1593 test, each set of infusion system should contain 20% bacterial endotoxins. The content of bacterial endotoxins should be less than 5.5EL/mL
7.4 Dissolution
According to T14233.2, the hemolysis rate of the sample should be less than 5%. Design: For further biological tests, see the World Record [], 8 Inspection specifications
8.1 Type inspection
8.1.1 Type inspection should be carried out in the following cases: 1) Before the production of new products (old products are produced by the factory) 6) During the three-year period, the vehicle is not produced again: 7) When the time is more than half a year, the process and materials have changed: 8.1.2 When the type inspection is released, the small review and evaluation should be carried out according to the basic principles of CB/T16886.1. If there is no special requirement for other requirements, each random inspection shall be carried out for 3 sets. 8.1.3 All type inspection items shall be inspected for the average daily quality, and then the recent type inspection shall be carried out. 8.2 Factory inspection (recommended)
8.2.1 Factory inspection shall be carried out in accordance with G5/T2828, and qualified products shall be shipped. 8.2.2 The production batch shall be composed of materials, process equipment and production time conditions. 8.2.3 The items required for inspection/qualification (counting items) shall be classified as unqualified, inspection level (1I) and overall quality level (AQ1. According to the provisions of Table [.
Table 1 Factory inspection rate
Qualification rate items
Strict trade
Shenyun Nan
Pharmaceutical performance filter
Slightly limited image number
Light treatment emblem
8.2.4 The production batch shall also be inspected: original material (6,2), dare to reduce (G.1), ultraviolet reception ( .6) and endogenous sulfide (7.3). B.2.5 When the same batch of products is sterilized by the same sterilization process, each batch shall be sterilized by sulfur-free method to achieve the effect of sterilization (7.2). The sterilization of the products shall be controlled to be below the prescribed level (6)! 9 Marking
9.1 Single packaging
The single packaging shall be marked with at least the following information: a) Product name;
1) Product treatment parameters:
Nominal volume:
1. Nominal flow rate (fourth indication marked on the product Effective dosage of the product
Controlled dosage [If there is a self-regulating dosing device; self-controlled dosing interval (such as: the first white controlled dosing device) design: Strict dosing can only be avoided in the instructions for use, especially bacteria, light and heat sources, a quick use of text instructions or pure use of the graphic symbols given in YY313: text instructions for sterilization or use of the graphic symbols in YY/T313: instructions for use or precautions, brackets\the instructions for "prohibited use due to damage to the packaging" and "destroy after use" e
() Batch number: | |tt||Expiration year sheet (must be clearly identifiable)
Manufacturer, distributor, name and address. 9.2 Outsourcing fee
Outsourcing form should comply with YY/T031S.
10 Packaging
10.1 Infusion should be packaged in single pieces. After opening, the single package should show signs of being opened. 10.2 The infusion package should be protected from damage during transfer and sterilization. 10.3 There should be no visible foreign matter in the single package YY0451-2003
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A1 Test product
Particle counter, - change the sampling volume to ml., A.2 Test filter
Appendix A
(report standard)
Removal rate test method
Diameter 5m-0.5T stock milk thousands of suspension night, every 100mL test solution (mass concentration of 9g/L oxidized solvent) contains O UUO amine particle standard material
A,3 steps
collect 2! Details, before taking the drug filter sensor. A single clean 100mL injection of 60mT. Test (A.2, injection, from the cross section of the test at a rate of 1CmE/min through the test tube, the liquid outflowing into the clean counting sample pool: 2mL of the sample volume in the sample pool filter this cut 5Am0,5m particles count. A. 4 Result calculation
according to the formula (A, 1) to add the prisoner of the other, expressed as a percentage: (1-) × 10
\; - the number of particles in the filter wave, the unit is: the number of particles in the test liquid, the unit is Note: The test treasure is carried out in a clean environment, 6
B.1 General Provisions Appendix B (Standard Appendix) Determination of Liquid Parameters of Infusion Pumps TY0451-2003 The test should be carried out under the conditions of ambient temperature of 23 ± 2 and atmospheric pressure of 86.0kP--106.0kP. This test method is applicable to all types of infusion systems. When necessary, it should be carried out in combination with the output according to the instructions. B.2 The test device is shown in Figure 1. Note that other methods that have been verified and recognized by this method can be used. Transfusion system characteristics: Liquid storage tank with balance (seat 0,001): B. 1 Initial parameters Test weight
B.3 Quantity of infusion
B 3.1 Steps
Pour 23 ± 2℃ saturated water into the infusion device to the nominal capacity (accurate to 1), and fill it up, remove the bubbles, arrange the test device according to H.2, and record the measurement value every hour from the time of infusion (0) until the infusion volume exceeds the marked effective infusion volume (as shown in Figure B.2)
(see the figure below)
Figure 2 Curve of infusion flow rate and time YY0451-2003
B.3.2 Result expression
B. 3.2. 1Average flow
Calculate the amount using 1:
Formula:
Unit: mT/h per hour./
Achieve the effect after the previous record, in grams (g): water density, 1g/ml;
Method and number of white volume after the balance before the previous record. Unit: hour (h) record and standard, unit: hour
B.3.2.2 Interval flow
Allow the interval flow at a certain moment to stop by formula (6.2): 2
Instantaneous flow, unit: liter per hour (mL/h); the balance recorded, unit:
First record of the level number, unit: gram (g) water density, 1R/mE;
! , the time to record the first time, the unit is hour (hf.-i
the time to record the first time, etc.The unit is hour (h). (H, 1)
(B, 2)
Take the opening time flow and report the maximum medical flow (), take the flow that reaches the marked effective transmission point without any flat flow before the previous recording point and report the negative single chart (
.4 Automatic control table parameter refresh volume
D. 4. 1 Steps
H.4.1.1 Special 2Y: Inject purified water into the infusion system to the nominal narrow wing (15). And fill it with the air in the pipeline, follow the diagram B1 for the test, H.4.1.2 The first group of quantities
Press the double injection force to infuse at least twice the full interval time (), press the self-control liquid supply T switch once, record the balance increment V), pass U.6 and touch the white control supply hoop again and close it, record the half-day increase V, pass 2c and change the pressure to the control supply switch, record the half-increase disk (V). The test pressure is shown in H,3. After the "next time" signal is turned on and off, the self-powered switch is turned on and off until the device is released. B. 4. 1. 3 The second set of measurements
The nominal volume of the discharged liquid is divided into two parts: B4. 2. 2: B, 4. 2 The results are shown in
11. 4. 2.1 The average increment of the two sets of measurements recorded by the first touch pressure is connected with the value of the energy dose V=B, 4. 2. 2. The interval time of automatic controlled lubrication
is the two corrected doses. V should not be less than V: V should not be significantly less than V, whether the interval of random liquid feeding is unqualified: Note: the difference can be more than 1%.
Double-limit tube type
Single-limit tube type
Y0451-2003
Society; Please see the infusion system with visual inspection for the packaging. It is divided into single-flow type and single-flow type. The double-flow infusion system adopts the self-controlled dosage reduction disk. The dosage is different in the market. The single-flow type injection system needs to add the next dose before the total actual dose is actually output. The subsequent dose will be less than the normal reading. Figure B.3 Typical automatic control feed parameter test diagram TY0451-2003
CI principle
Appendix
(Informative Appendix)
Principle of the automatic measurement system for the process control of the initial liquid parameters of the infusion channel Since the test method in Appendix B is relatively complex, it is not suitable for process control. The average flow rate of a certain infusion channel depends on the inner diameter and length of the final limiting tube. The system described in this Appendix shows that the size of the gas flow through the limiting tube has a certain relationship with the feed parameters. This relationship needs to be verified by the method given in Appendix B, so as to indirectly control the filtration parameters. C.2 Automatic detection device cabinet diagram
Figure C.1 shows the diagram of the dynamic detection device for process control, which is a block diagram of the automatic detection of loading quantity.
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