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YY/T 0619-2017Medical endoscopes - Rigid resectoscope (English PDF)

医用内窥镜硬性电凝电切内窥镜

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 28, 2017

Implementation date

January 1, 2018

Scope

YY/T 0619-2017 is the English-translated version of 医用内窥镜硬性电凝电切内窥镜.

YY/T 0619-2017 is the Chinese pharmaceutical industry standard for the rigid resectoscope, the endoscope through which tissue is resected electrosurgically, above all in the prostate and the bladder.

It gives the classification and composition, the requirements and the test methods, covering the optics and the field and direction of view, the working element and the electrode, the sheath and the irrigation channels, the insulation and the leakage current that matter where high frequency current is used, and the cleaning and sterilization of the instrument. Issued on 28 February 2017, it has applied since 1 January 2018.

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Document preview — YY/T 0619-2017

National Standard of the People's Republic of China

Replacing: YY 0619-2007

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

Foreword3
1 Scope5
2 Normative References5
3 Classification and Composition6
4 Requirements6
5 Test Methods11

1 Scope

This Standard specifies the classification and composition, requirements and test methods of rigid resectoscope.

This Standard is applicable to the rigid resectoscope (hereinafter referred to as resectoscope). The resectoscope is clinically applicable to the cutting, vaporizing and coagulating operations against the diseased tissues under the direct viewing of endoscope and using the high-frequency current thermal effect.

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document.

GB 9706.4 Medical Electrical Equipment - Part 2-2. Particular Requirements for the Safety of High Frequency Surgical Equipment

GB 9706.19 Medical Electrical Equipment-Part 2. Particular Requirements for the Safety of Endoscopic Equipment

GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipment for Medical Use - Part 1. Chemical Analysis Methods

GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1. Evaluation and Testing Within a Risk Management Process

YY 0068.1-2008 Medical Endoscopes - Rigid Endoscope - Part 1. Optical Properties and Test Methods

YY 0068.2-2008 Medical Endoscopes - Rigid Endoscope - Part 2. Mechanical Properties and Test Methods

YY 0068.3-2008 Medical Endoscopes - Rigid Endoscope - Part 3. Marking and Instruction Manual possible measures to minimize the undesired hazard

a) Warn the possible hazard indications, means of prevention of hazard, and the handling instructions after hazard is discovered;

b) Safe operating procedures;

c) The instructions that can be used by the operator after special training.

4 Requirements

4.2.2.6.2 In the view filed of the endoscope, the visible head end part of the surgical electrode shall have no directional reflection phenomenon that may influence the use.

4.5.4 Dissolved precipitates of polymer materials in contact with the patient 4.5.4.1 pH. compared with the same batch of blank control solution, the pH difference shall be no greater than 2.0.

4.5.4.2 Total content of soluble heavy metals. the total content of the soluble heavy metals in the dissolution solution shall not exceed 5.0µg/mL.

4.5.4.3 Potassium permanganate reducing substance. the consumption difference with the same volume of the same batch of blank control solution shall be no more than 2.0mL.

4.2.2.7 Visibility of surgical electrode

When the surgical electrode is moved to the distal position with the moving part of the manipulator, its head end shall be within the range observable by the endoscope

4.3 Conduction performance

The high-frequency connection wire and surgical electrode of resectoscope shall be well-conducted; its impedance value shall be less than 3ohm.

4.4 Label and attaching document

4.4.1 General requirements of label and attaching document

It shall meet the requirements of YY 0068.3-2009.

4.4.2 Other requirements of label and attaching document

The manufacturer shall indicate in the instruction manual the possibility of heat and other risks to the patient and operator when using the product.

a) Thermal damage to the endoscope due to electrical spark or capacitively coupling high-frequency current;

b) Image interference on the video screen caused by high-frequency electromagnetic waves;

c) Keep the working part of the charged electrode within the operator's observation range to avoid accidental high-frequency burns;

d) In order to ensure that the charged electrode in the correct position during the operation, it must be kept sufficient distance away from the head end of the endoscope; it shall avoid contacting with the metal parts and other conductors of the endoscope before exciting the high-frequency output, including the liquid vent that may be conductor; application; or information about the material and/or device is otherwise available, and the material has been previously proven to be applicable.

NOTE2. If metallic material uses the medical metallic material suitable for the application range of the national and industry standards, biological test may not be repeated.

4.6 Corrosion resistance (applicable to the non-disposable products)

The martensitic and austenitic stainless-steel materials are tested as per the boiling water test method specified in YY/T 0149-2006, which shall meet the requirements of Class-b; the remaining materials shall be performed once disinfection and sterilization method that is most unfavorable for the device specified by the manufacturer in the instruction manual, which shall meet the requirements of Class-b.

4.7 Disinfection and sterilization

4.7.1 Resistance of the re-disinfected and re-sterilized products

It shall meet the requirements of YY 0068.4-2009.

4.7.2 Sterile supply product

It shall meet the requirements of YY 0068.4-2009.

4.8 Package

It shall meet the requirements of YY 0068.4-2009.

4.9 Electrical safety performance

4.9.1 The electrical safety performance requirements of endoscope shall meet the requirements of YY 0068.4-2009.

4.9.2 The electrical safety performance requirements of surgical electrode shall meet the requirements of GB 9706.4.

5 Test Methods

5.5.4 Test on the dissolved precipitate of polymer material in contract with patient 5.5.4.1 Preparation of test solution. prepare according to the sixth method in Table 1 of GB/T 14233.1-2008.

5.5.4.3 Heavy metal. follow the method specified in 5.6 of GB/T 14233.1-2008.

5.5.4.4 Potassium permanganate reducing substance. follow the method specified in 5.2 of GB/T 14233.1-2008.

5.5.2 Material quality requirement test

The main structure of the polymer material shall be confirmed by verification data provided by the manufacturer.

Chemical composition test of the metallic material. take the method with accuracy greater than or reaching the tolerance or 1/3 limit value to carry out the chemical composition analysist test of the material.

5.5.3 Biocompatibility test

All tests are preferred to use the relevant standards of GB/T 16886 and perform the test as per their methods.

5.6 Corrosion resistance (applicable to the non-disposable products) test

The martensitic and austenitic stainless-steel materials shall be tested as per the boiling water test method in YY/T 0419-2006. The remaining materials shall be disinfected and sterilized once according the specified method in the instruction manual; make them cool off to the room temperature in the air; then check the corrosion marks on the product surface; the test on the corrosion degree shall be evaluated according to the 5.4 of YY/T 0149-2006.

5.7 Disinfection and sterilization test

5.7.1 Resistance test for the re-disinfected and re-sterilized products

Follow the method specified in YY 0068.4-2009; verify the conformity of 4.7.1 requirements.

5.7.2 Sterile supply product test

Fellow the method specified in YY 0068.4-2009; verify the conformity of 4.7.2 requirements.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0068.3-2008|YY 0068.4-2009|YY 0068.1-2008|YY/T 1028-2023|YY/T 1587-2018|YY/T 1603-2018

Editions of YY/T 0619

Edition	Title	Revision	Status
YY/T 0619-2017	Medical endoscopes - Rigid resectoscope	current edition	Current
YY 0619-2007	Medical endoscopes - Rigid resectoscope	previous edition	Superseded

This page sells the current edition, YY/T 0619-2017. Earlier editions are listed for reference only.

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