YY/T 0619-2017: Translated English of Chinese Standard. YY/T0619-2017: Medical Endoscopes - Rigid Resectoscope
https://www.chinesestandard.net, 10. aug. 2018 - 14 sider
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.
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Add the requirements attaching document Biocompatibility biological tests biosafety blank control solution charged electrode chemical composition closed position connection positions Connection reliability Disinfection and sterilization Dissolved precipitates Edition electrical safety performance electrode and manipulator electrode shall meet eyepiece follow the method head end high-frequency burns high-frequency connection wire high-frequency current inlet and outlet instruction manual label and attaching material quality Maximum width mechanical property test Medical Device Medical Endoscopes meet the requirements metallic material method specified nominal value Optical performance Outer surface quality outlet valve permanganate reducing substance polymer material pressure of 10kPa re-sterilized products requirements of Class-b requirements of YY resectoscope see 4.1 Rigid Endoscope Rigid Resectoscope safety performance requirements source with pressure special measuring gauges specified in GB/T specified in YY Standard Sterile supply product Surface material surgical electrode insertion Surgical electrode stroke test of endoscope test of surgical test Respectively screw verity the conformity wire and surgical YY/T