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YY/T 0864-2011Medical endoscopes - Endoscope functional supply units - Irrigation pump (English PDF)

医用内窥镜 内窥镜功能供给装置 液体膨宫泵

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY/T 0864-2011 is the English-translated version of 医用内窥镜 内窥镜功能供给装置 液体膨宫泵.

YY/T 0864-2011 is the Chinese pharmaceutical industry standard for the irrigation pump used as a functional supply unit with a medical endoscope.

It sets the terms and definitions, the requirements and the test methods for such a pump, covering the flow rate and the pressure delivered and their accuracy and control, the tubing set it takes, the protection against over-pressure, the alarms and the electrical safety of the equipment. Issued on 31 December 2011, it has applied since 1 June 2013.

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Document preview — YY/T 0864-2011

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword3
  • 1 Scope4
  • 2 Normative references4
  • 3 Terms and definitions5
  • 4 Requirements5
  • 5 Test methods7

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.

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 Test methods

5.1.3 Determination of overvoltage and reduced-pressure function and overpressure alarm function

5.1.2.2.2 Measurement procedure

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.

5.1.3.1 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.

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.

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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