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YY/T 1469-2016 PDF English

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YY/T 1469-2016: Electrical infusion pump for ambulatory use
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YY/T 1469-2016: Electrical infusion pump for ambulatory use

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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.20 C 31 Electrical infusion pump for ambulatory use Issued on. JANUARY 26, 2016 Implemented on. JANUARY 01, 2017 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 1 Scope... 4 2 Normative references... 4 3 Terms and definitions... 5 4 Technical requirements... 6 5 Test method... 11 Appendix A (Informative) Guidelines and compilation instructions... 20

Foreword

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of Subcommittee 5 on Electromedical Equipment of National Technical Committee 10 on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 5). The drafting organizations of this Standard. Jiangsu Medical Device Inspection Institute, Shanghai Medical Device Testing Institute, Nantong Apon Medical Appliance Co., Ltd. The drafters of this Standard. Li Ning, Xu Jin, Wu Jiajun, Zhang Yichuan, Zhuo Yue, Chen Tao, Miao Jia. Electrical infusion pump for ambulatory use

1 Scope

This Standard specifies the definition, basic requirements and corresponding test methods of electrical infusion pump for ambulatory use (hereinafter referred to as infusion pump for ambulatory use). This Standard applies to electrical infusion pump for ambulatory use which are used in medical monitoring environments; the intended use of this product is for intravenous or epidural analgesic administration. The infusion pump for ambulatory use is mainly composed of a drive unit, a restoration set and an infusion line; the restoration set and the infusion line are single-use components. This Standard does not apply to the following equipment. -- equipment which is specially used for diagnostics or similar purposes (such as high-pressure injectors); -- gastrointestinal feeding pump; -- equipment for extracorporeal blood circulation; -- insulin pump and pumps for similar clinical applications; -- infusion pump for ambulatory use that has special requirements for infusion accuracy.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB/T 1962.1-2015, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1.General requirement GB/T 1962.2-2001, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2.Lock fittings GB 9706.1-2007, Medical electrical equipment - Part 1.General requirements for safety GB 9706.27-2005, Medical electrical equipment - Part 2-24.Particular requirements for the safety of infusion pumps and controllers GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for medical use - Part 1.Chemical analysis methods GB/T 14233.2-2005, Test methods for infusion, transfusion, injection equipment for medical use - Part 2.Biological test methods GB/T 14710-2009, Environmental requirement and test methods for medical electrical equipment

3 Terms and definitions

Terms and definitions determined by GB 9706.27-2005 and the following ones are applicable to this document. For ease of use, some of the terms and definitions in GB 9706.27-2005 are repeated below. 3.1 Infusion pump The device that is expected to control the flow of fluid into the patient's body by the positive pressure that is generated by the pump. 3.2 Infusion pump for ambulatory use The device that is used to control patient infusion and can be continuously carried by the patient. 3.3 Electrical infusion pump for ambulatory use The infusion pump for ambulatory use that is driven by electrical energy. 3.4 Drive unit The device that transmits the liquid to the patient through the infusion line by the positive pressure that is generated by the motor drive. 3.5 Restoration set The device for storing liquid in the infusion pump for ambulatory use. 3.6 Administration set The device that transmits the fluid from the fluid supply site to the patient via the device.

4 Technical requirements

4.1 Overall performance requirements 4.1.3 Infusion accuracy 4.1.3.1 The accuracy of the average infusion speed in continuous infusion mode shall be better than ±10%. 4.1.4 Blocking pressure, triggering time and the produced bolus volume 4.1.4.1 The infusion blocking pressure alarm threshold value shall be specified in the random file; the accuracy shall be better than ±20%. 4.2 Alarm information requirements 4.2.1 The infusion pump for ambulatory use shall contain at least the following alarm information, and shall use visual alarm and auditory (or other effective methods such as vibration) alarm. 4.2.2 The prompt sound pressure level of the infusion pump for ambulatory use shall not be lower than 45 dB(A). 4.3 Requirements for the single-use part 4.3.1 Physical properties 4.3.1.5 Restoration set The restoration set of the infusion pump for ambulatory use shall be designed to be able to visually inspect the foreign matter and air bubbles in the contained solution. 4.3.1.6 Particulate pollution When the test is performed in accordance with Appendix A of YY 0451-2010 or equivalent method, the pollution index shall not be greater than 90. 4.3.2 Chemical properties 4.3.2.1 Reducing substances The volume difference of potassium permanganate solution [c(KMnO4) = 0.002 mol/L] that is consumed between the test solution and the blank solution shall not exceed 2.0 mL. 4.3.2.4 Evaporation residue The total amount of evaporation residue shall not exceed 2 mg. 4.3.2.5 UV absorbance When the test is performed in the range of 220 nm ~ 360 nm, the UV absorbance of the test solution shall not be greater than 0.3. 4.3.2.6 Residue of ethylene oxide The residue of ethylene oxide shall be no more than 10 μg/g. 4.4 Safety requirements 4.4.1 The general safety requirements of infusion pump for ambulatory use shall meet the requirements in GB 9706.1-2007. 4.4.2 The general requirements for electromagnetic compatibility of the infusion pump for ambulatory use shall comply with the provisions of YY 0505-2012. 4.4.3 The alarm system of the infusion pump for ambulatory use shall comply with the provisions in YY 0709-2009, where Table 204 in Y Y0709-2009 is replaced by Table 1. 4.4.4 The special safety requirements of the infusion pump for ambulatory use shall comply with the requirements in GB 9706.27-2005.

5 Test method

5.1 Test conditions 5.1.1 Temperature during the test. 5 °C ~ 40 °C. 5.1.2 Relative humidity during the test. 20% ~ 90%. 5.2 Overall performance test 5.2.3 Infusion accuracy test 5.2.3.1 Continuous infusion mode accuracy test procedures Build the test platform as shown in Figure 1; use the grade-3 water for analysis laboratory; install a non-infused line for testing. 5.2.3.2 PCA (bolus) infusion mode infusion volume and infusion speed accuracy test 5.2.3.3 Chronological infusion accuracy test Use the test device in Figure 1; use the grade-3 water for analysis laboratory; install an unused infusion line for testing. Set the time period t1,..., ti, the infusion speed r1, r2,..., ri; calculate the infusion accuracy error in each time period. 5.2.4 Blocking pressure, triggering time and bolus volume test Connect the pressure sensor to the line and build the platform according to Figure 2. 5.4.1.8 Residual amount of liquid medicine The residual amount of liquid medicine in the restoration set and restoration line shall be the volume of the restoration minus the nominal volume; the result shall meet the requirements of 4.3.1.8. 5.4.2 Chemical properties The preparation of the test solution of 5.4.2.1 ~ 5.4.2.5 is in accordance with the method of "Serial No. 5" in Table 1 of GB/T 14233.1-2008. 5.4.2.1 Reducing substances Perform the test according to the provisions in 5.2.2 of GB/T 14233.1-2008, which shall meet the requirements of 4.3.2.1. 5.4.2.6 Residue of ethylene oxide Take samples from the restoration set; perform the test according to the provisions in GB/T 14233.1-2008, which shall meet the requirements of 4.3.2.6. 5.4.3 Sterile and pyrogen-free Perform the test according to the provisions in GB/T 14233.2-2005. 5.4.4 Biological evaluation Perform the biological evaluation according to relevant parts of GB/T 16886. 5.5 Safety test 5.5.1 The general safety requirements of infusion pump for ambulatory use shall 5.6 Environmental test requirements The environmental requirements of the infusion pump for ambulatory use shall be tested in accordance with the climatic environment group II and mechanical environment group II in GB/T 14710-2009 and the regulations of the manufacturer. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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