医疗器械分类之第三类列表(国外英文资料).doc

医疗器械分类之第三类列表(国外英文资料) A client of the medical equipment service for medical device classification statistics, the state food and drug administration of the classified management of medical equipment, not hierarchical. There are three classes: The first category is medical devices that are routinely managed to ensure their safety and effectiveness. The second category refers to medical devices that are controlled by their safety and effectiveness. The third category is the implant; To support and sustain life; A medical instrument that is potentially dangerous to the body and must be strictly controlled for its safety and efficacy. The most tightly managed is three types of instruments, which are detailed below: The classification directory name is used as an example Ophthalmological surgery of 6804 eye surgery instrument is used in other machine glass body cutter 6815 injection puncture instrument Injection puncture instrument Disposable sterile syringe and the rubber plug, one-time use of sterile needles, disposable venous infusion needle, one-time use optical fiber, intravenous indwelling needle, one-time dispensing with needle, needle 6821 medical electronic instruments and equipment For the treatment of heart, first aid equipment Implantable cardiac pacemakers, heart pacemakers, defibrillators, heart in vitro cardiac modulator, aortic internal capsule counterpulsation device, heart except quiver pacemaker Have the electrophysiological instrument and innovative electrophysiological instrument extracorporeal shock wave lithotriptor, patients have a monitoring system, intracranial pressure monitor, and cardiac output meter, and guide more physiological recorder and the hearts electrical drawing machine, beam heart inside and outside membrane plotter, invasive electronic sphygmomanometer There are medical sensors implanted in the body of a medical sensor The non-invasive monitoring instrument and the monitor of the arrhythmias, the s-t-segment monitor Medical stimul