YY/T 0864-2011_English: PDF (YY/T0864-2011)
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Medical endoscopes - Endoscope functional supply units - Irrigation pump
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YY/T 0864-2011
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| Standard ID | YY/T 0864-2011 (YY/T0864-2011) | | Description (Translated English) | Medical endoscopes - Endoscope functional supply units - Irrigation pump | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 9,933 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB 9706.1-2007; GB 9706.19-2000; GB/T 14233.2-2005; GB/T 14710-2009; GB/T 16886.1-2011; GB/T 16886.5-2003; GB/T 16886.7-2001; GB/T 16886.10-2005; YY 0709-2009 | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee of Medical optics and instruments | | Regulation (derived from) | State Food and Drug Administration Notice No. 106 of 2011 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies requirements for medical endoscope expansion chamber with a liquid pump (hereinafter referred to as swelling cavity pumps) requirements. This standard applies to the use of endoscopic surgery swelling cavity pumps. The products are used in minimally invasive endoscopic surgery expansion chamber. |
YY/T 0864-2011
Translated English of Chinese Standard. YY/T0864‐2011
YY
ICS 11.040.99
C 40
INDUSTRY STANDARD
OF THE PEOPLE’S 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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