YY_T 0987.2-2016外科植入物 磁共振兼容性 第2部分：磁致位移力试验方法.pdf

ICS 11.040.40C 35YY中华人民共和国医药行业标准YY/T 0987.2—2016外科植入物1磁共振兼容性第2部分：磁致位移力试验方法Implants for surgery—Magnetic resonance compatibility-Part 2:Magnetically induced displacement force test method2016-03-23发布2017-01-01实施国家食品药品监督管理总局发布 YY/T 0987.2—2016目次前言范围2规范性引用文件术语和定义试验方法概述5意义和应用6仪器设备试验样品步暖数据处理10报告附录A(资料性附录)基本原理参考文献 YY/T 0987.2—2016参考文献[Gegauff, A,G., Laurell, K. A., Thavendrarajah, A,, and Rosenstiel, S.F.,*A Potentisl MRIHazard;Furces un Dental Maget Keepers,Juurmal uf Oral Rehabilitatiun, vul.17,1990 +pp,403-410[2JKagetsil, N.J., and 1.itt, A. W., Important Considerations in Measurement of AttractiveForce on Metallie Implents in MR Imsgera,Radiology,vol.179,1991,pp.505-508[3] Kanal, E., and Shellock, F, G., Aneurysm Clips: Effects of Long-termand MultipleExposures to a 1.,5-T MR System, Radiology,vol.210,1999,pp.563565[4JNew,P.F.,Rosen,B.R.,Brady,T.J.,Buonarmo,F.S,,Kistler,J.P.,Burt,C,T.,Hinshaw, W.S., Newhouse, J. H.. Pohost, G. M., sndTaveras, J. M., Potential Hazards and Artifaets ofFerromagnetic andNonferromagnetic Surgical and Dental Materials and Devices inNuclear MagneticResonance Imaging, Radiology,vol.147,1983.pp.139-148[5]Planert,J.,Modler, H,,and Vosshenrich,R,,Measurements of Magnetism—Related Forcesand Torque Moments Affecting Medicallnstruments, Implants,and Foreign Objects During MagneticResonance Imaging at all Degrees of Freedom, Medical Physics, vol.23,1996,pp.851856[6] Planert,J.,Modler, H.,Lijdecke,and Eger,M.,A MiniaturisedForceTorque Sensor withSix Degrees of Frcedom for Dental Measurements, Clin.Phys.Physiol.Meas. ,vol.13, 1992, pp.241-248[7]Schenek,J.F.,*The Role of Magnctie Susceptibility in MagnetieResonanee Imaging: MRIMagnetic Compatibility of the First andSecond Kinds, Medical Physics,vol,23,1996, pp.815-850[8] Shellock,F.G,, and Kanal, E.,Yasargil Aneurysm Clips; Evalustionof Intersetions with a1.5-T MR Systel, Radiulugy, vol.,207,1998,Pp.587-591[6]Shellock, F. G., and Shellock, V.J., Cardiovasenlar Catheters andAceessories: Ex VivoTeati