YY/T 0619-2017 English PDF (YYT0619-2017)

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.

YY/T 0619-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.99
C 40
Replacing YY 0619-2007
Medical Endoscopes – Rigid Resectoscope
ISSUED ON. FEBRUARY 28, 2017
IMPLEMENTED ON. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Classification and Composition ... 6
4 Requirements ... 6
5 Test Methods ... 11
Medical Endoscopes – Rigid Resectoscope
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. All the adopted measures shall at least include the following instructions in the attaching document.
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. 4.2.2.6.2 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. 4.2.2.7 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 3Ω.
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. 4.5.4 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.
4.6 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.
5.5.2 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.
5.5.4 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.
5.5.4.2 pH. follow the method specified in 5.4.1 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.
5.6 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.