YY 1075-2007 Translated English of Chinese Standard. YY1075-2007: Rigid hysteroscopehttps://www.chinesestandard.net, 30 มี.ค. 2019 - 26 หน้า This standard specifies the classification and marking, requirements, test methods, inspection rules, signs, labels and instructions for use, packaging, transportation, storage of rigid hysteroscope. This standard applies to rigid hysteroscope (hereinafter referred to as hysteroscope). Hysteroscope is mainly used in the medical clinical diagnosis of uterine cavity disease and treatment together with surgery instruments. This standard does not apply to high-frequency electric hysteroscope. |
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accompanied file angle of view Appendix A Normative biocompatibility Biological evaluation carried out according Check the accompanied cold light source Connect Continuous leakage current Dielectric strength edge endoscope’s evaluation of medical eyepiece field of view firm and reliable following requirements hysteroscope shall meet illuminance value illuminometer probe indexing plate insertion inspection certificate inspection hysteroscope instruction manual instrument channel leakage current tester light guide Magnification matching cold light measuring target medical devices medical electrical equipment meet the following meet the requirements method as specified millimeters nominal value Normal test object side obturator optical bench outer surface packaging perpendicular provisions of GB requirements of 4.4 requirements of clause resolution and illuminance resolution plate results shall comply results shall meet rigid hysteroscope Rotation angle sine wave specified in GB/T standard storage test Table A.2 temperature Test methods Check tested according Type inspection view and angle view is measured wet pretreatment