医疗器械的分类
1一类医疗器械
手术刀柄和刀片、普通止血钳、子弹钳、纱布剥离钳、海绵钳、帕巾钳、皮管钳、器械钳、显微耳针、显微喉针、显微耳钩、显微喉钩、显微枪形麦粒钳、显微喉钳、显微持针钳、角膜镊、眼用镊、眼用结扎镊、纱布绷带、弹力绷带、石膏绷带、创口贴、手术衣、手术帽、口罩、手术垫单、手术洞巾、检查手套,指套、洗耳球、阴道洗涤器、气垫、肛门袋,圈、集尿袋、引流袋等;
2二类医疗器械
如体温计、血压计、助昕器、制氧机、避孕套、针灸针、心电诊断仪器、无创监护仪器、光学内窥镜、便携式超声诊断仪、全自动生化分析仪、恒温培养箱、牙科综合治疗仪、医用脱脂棉、医用脱脂纱布等;
3三类医疗器械
如植入式心脏起搏器、体外震波碎石机、病人有创监护系统、人工晶体、有创内窥镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波治疗仪、医用核磁共振成像设备、X线治疗设备、医用高能设备、人工心肺机、内固定器材、人工心脏瓣膜、人工肾、呼吸麻醉设备、一次性使用无菌注射器、一次性使用输液器、输血器、CT设备等。
llection, urine bag, drainage bag, etc.; 2 Class II medical devices Such as thermometer, blood pressure monitor, aid, oxygen generator, condoms, acupuncture needle, ECG diagnostic instrument, non-invasive monitoring instrument, optical endoscope, portable ultrasonic diagnostic instrument, automatic biochemical analyzer, constant temperature incubator, dental comprehensive treatment instrument, medical skim cotton, medical degreasing gauze, etc.; 3 Class III medical devices Such as implantable cardiac pacemaker, external shock wave lithotripsy machine, patient invasive monitoring system, artificial lens, invasive endoscope, ultrasonic scalpel, color ultrasound imaging equipment, laser surgery