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YY/T 0864-2011 English PDF (YYT0864-2011)

YY/T 0864-2011 English PDF (YYT0864-2011)

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YY/T 0864-2011: Medical endoscopes - Endoscope functional supply units - Irrigation pump

This Standard specifies the requirements for the irrigation pump that is used for medical endoscope. This Standard applies to irrigation pump that is used in endoscope surgery. It is used for the irrigation in the minimally invasive endoscope surgery.
YY/T 0864-2011
Translated??English??of??Chinese??Standard.??YY/T0864?€?2011
YY
ICS 11.040.99
C 40
INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
Medical endoscopes - Endoscope functional
supply units - Irrigation pump
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 1, 2013
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Requirements ... 5
5 Test methods ... 7
Foreword
This Standard is drafted according to the rules specified in GB/T 1.1-2009 Please note that some contents in this document may involve in patents. The issuing authority of this document will not be responsible to identify these patents. This Standard was proposed by China's State Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Sub-committee (SAC/TC 103/ SC 1) on Medical Optical and Instrument of Standardization Administration of China.
Drafting organizations of this Standard. Hangzhou Medical Equipment Quality Supervision and Inspection Center of State Food and Drug Administration, and Zhejiang Medical Equipment Inspection Center.
The main drafting staffs of this standard. Yan Qinglai, Jia Xiaohang, He Tao, Qi Weiming Zhang Qinyuan, and Zheng Jian.
Medical endoscopes - Endoscope functional supply
units - Irrigation pump
1 Scope
This Standard specifies the requirements for the irrigation pump that is used for medical endoscope.
This Standard applies to irrigation pump that is used in endoscope surgery. It is used for the irrigation in the minimally invasive endoscope surgery.
2 Normative??references
The articles contained in the following documents have become part of this document when they are quoted herein. For the dated documents so quoted, all the modifications (Including all corrections) or revisions made thereafter shall be applicable to this document.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for the safety of endoscopic equipment
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
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. Test for in vitro cytotoxicity
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity
Connect the irrigation pumps with pipelines, and supply water source according to the provisions in the attached information.
After the connection between the pipeline outlet and the pressure buffer, connect the hydraulic pressure gauge.
Control the power supply of the irrigation pump to maintain it stable at the nominal voltage. This voltage shall be monitored. The voltage stability shall be controlled within ?? 2%. After the completion of the starting self-check procedure of the irrigation pump, it shall show that each component works normally.
5.1.2.2.2 Measurement procedure
Set the setting pressure limit on the irrigation pump, expressed as ps. If the setting flow of the irrigation pump is adjustable, set the flow of the irrigation pump to the maximum value. Start to inject in liquid. Read the actual pressure on the hydraulic pressure gauge after it is stabilized, expressed as pr.
If the setting pressure limit on the irrigation pump is adjustable, ps shall at least take the highest value, medium value, and the lowest value but not less than 3999Pa (30mmHg). Measure 3 times for each test point. Take the average value as the measurement result pr. 5.1.2.3 Results representation
The deviation of the pressure limit setting is expressed in the maximum deviation between the actual pressure and the setting pressure limit, expressed as Aps.
Relative value is indicated as Aps = (pr - ps) / ps; absolute value is indicated as Aps = pr - ps. The result shall indicate the ps, pr and Aps values, when the ps is respectively the 3 values set in 5.1.2.2.2.
5.1.3 Determination of overvoltage and reduced-pressure function and
overpressure alarm function
5.1.3.1 Device
5.1.3.1.1 Hydraulic pressure gauge
Same as 5.1.2.1.
5.1.3.1.2 Elastic cysts
It can collect liquid, with elasticity. It has 2 interfaces - of which one can be connected to the exit of irrigation pump pipeline; and the other can be connected to the hydraulic pressure gauge to measure the actual hydraulic pressure in the elastic cysts. 5.2.2.1.2 Timer
The accuracy shall be within 0.1s.
5.2.2.2 Steps
5.2.2.2.1 Preparatory work
Connect the irrigation pumps with pipelines, and supply water source according to the provisions in the attached information.
The outlet of the pipeline is connected with the container of measuring liquid volume. Control the power supply of the irrigation pump to maintain it stable at the nominal voltage. This voltage shall be monitored. The voltage stability shall be controlled within ?? 2%. After the completion of the starting self-check procedure of the irrigation pump, it shall show that each component works normally.
5.2.2.2.2 Measurement procedure
This test is conducted under the state that the end of the pipeline is opened. Set the setting pressure limit on the irrigation pump to the highest value. Set the setting flow on the irrigation pump, expressed as Ls.
Start to inject in liquid. Stop the liquid injection after t min. Measure the volume of injected liquid at the pipeline outlet, expressed as V.
Obtain the actual flow Lr through calculation by Formula Lr = V/t.
If the setting pressure limit of irrigation pump is adjustable, Ls shall at least take the highest value, medium value and the lowest value within the flow range but not less than 50mL/min (0.003m3/h). Measure 3 times for each test point. Take the average value as the measurement result Lr.
5.2.3 Results representation
The deviation of the setting flow is expressed in the maximum deviation between the actual flow and the setting flow, expressed as ALs.
When the setting flow is ???100mL / min (0.006m3/h), ALs is expressed in relative value, i.e. ALs = (Lr - Ls)/ Ls. When the he setting flow is < 100mL / min (0.006m3/h), ALs is expressed in absolute value, i.e. ALs=Lr - Ls.
The result shall indicate the Ls, Lr and ALS values, when the Ls is respectively the 3 values set in 5.2.2.2.2.
5.3 Test of the pipeline
9706.19-2000.
5.5 Environmental test
The mechanical environmental tolerance test shall be conducted according to provisions of Mechanical Environment Group II in GB/T 14710-2009.
Climatic environmental tolerance test shall be conducted in accordance with GB/T 14710-2009.

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