医疗器械中英文

1、hematology and pathology devices血液学和病理学医疗器械中英文对照a亚部总则(general provisions)864.1范围scope864.3有关上市前批准生效日期的要求effective dates of requirement for premarket approval864.9联邦食品、药品和化妆品法第510(k)节的豁免限制limitations of exemptions from section 510(k) of the federal food, drug, and cosmetic act (the act).b亚部生物染色(biolo

2、gical stains)864.1850染料和化学溶液染色剂dye and chemical solution stains864.1860免疫组织化学试剂和试剂盒immunohistochemistry reagents and kitsc亚部细胞和组织培养产品(cell and tissue culture products)864.2220人造细胞和组织培养基及成分synthetic cell and tissue culture media and components864.2240细胞和组织培养供应品及设备cell and tissue culture supplies and

3、equipment864.2260染色体培养试剂盒chromosome culture kit864.2280培养的动物和人体的细胞cultured animal and human cells864.2360支原体检测介质和成分mycoplasma detection media and components864.2800动物和人的血清animal and human sera864.2875平衡盐溶液或配方balanced salt solutions or formulationsd亚部病理学检测设备和附件(pathology instrumentation and accessori

4、es)864.3010组织处理装置tissue processing equipment864.3250标本运送和储存容器specimen transport and storage container864.3260用于药物滥用检测的otc检测样品收集系统otc test sample collection systems for drugs of abuse testing864.3300细胞离心机cytocentrifuge864.3400显微切片封接器械device for sealing microsections864.3600显微镜及其附件microscopes and acce

5、ssories864.3800自动载玻片着色器automated slide stainer864.3875自动组织处理器automated tissue processore亚部标本制备试剂(specimen preparation reagents)864.4010通用试剂general purpose reagent864.4020被分析物特效试剂analyte specific reagents864.4400酶制剂enzyme preparationsf亚部自动和半自动血液学装置(automated and semi-automated hematology devices)864.

6、5200自动细胞计数器automated cell counter864.5220自动差分细胞计数器automated differential cell counter864.5240自动血细胞稀释器automated blood cell diluting apparatus864.5260自动细胞定位装置automated cell-locating device864.5300红细胞指数器械red cell indices device864.5350微沉淀离心机microsedimentation centrifuge864.5400凝结装置coagulation instrumen

7、t864.5425体外凝结研究用多用途系统multipurpose system for in vitro coagulation studies864.5600自动血球容积计automated hematocrit instrument864.5620自动血色素系统automated hemoglobin system864.5680自动肝磷脂分析仪automated heparin analyzer864.5700自动血小板聚集系统automated platelet aggregation system864.5800自动沉降速率装置automated sedimentation rat

8、e device864.5850自动载玻片旋转器automated slide spinner864.5950血液容积测量装置blood volume measuring deviceg亚部手动血液学装置(manual hematology devices)864.6100出血时间测定装置bleeding time device864.6150毛细血液收集管capillary blood collection tube864.6160手动血细胞计数装置manual blood cell counting device864.6400血球容积测量装置hematocrit measuring de

9、vice864.6550潜隐血检测occult blood test864.6600渗透脆性检测osmotic fragility test864.6650血小板粘附检测platelet adhesion test864.6675血小板聚集测量计platelet aggregometer864.6700红血球沉降速率检测erythrocyte sedimentation rate testh亚部血液学试剂盒和工具苞(hematology kits and packages)864.7040三磷酸腺苷释放化验adenosine triphosphate release assay864.7060

10、抗血栓iii化验antithrombin iii assay864.7100红血球酶化验red blood cell enzyme assay864.7140活性全血凝固时间检测activated whole blood clotting time tests864.7250促红细胞生成素化验erythropoietin assay864.7275真球蛋白消散时间检测euglobulin lysis time tests864.7280因子v莱顿dna转变探测系统factor v leiden dna mutation detection systems864.7290因子缺乏检测factor

11、 deficiency test864.7300纤维单体副凝检测fibrin monomer paracoagulation test864.7320纤维蛋白原/纤维蛋白降解产物化验fibrinogen/fibrin degradation products assay864.7340纤维蛋白原测定系统fibrinogen determination system864.7360红血球葡萄糖6磷酸脱氢酶化验erythrocytic glucose-6- phosphate dehydrogenase assay864.7375谷胱甘肽还原酶化验glutathione reductase ass

12、ay864.7400血色素a2化验hemoglobin a2 assay864.7415异常血红蛋白化验abnormal hemoglobin assay864.7425羧络血红蛋白化验carboxyhemoglobin assay864.7440血色素电泳分析系统electrophoretic hemoglobin analysis system864.7455胎儿血红蛋白化验fetal hemoglobin assay864.7470糖基化血色素化验glycosylated hemoglobin assay864.7490含硫血色素化验sulfhemoglobin assay864.750

13、0全血血色素化验whole blood hemoglobin assays864.7525肝磷脂化验heparin assay864.7660白细胞碱性磷酸酶检测leukocyte alkaline phosphatase test864.7675白血病过氧化物酶检测leukocyte peroxidase test864.7695血小板因子4放性免疫测定platelet factor 4 radioimmunoassay864.7720凝血素消耗量检测prothrombin consumption test更多内容请参考医学知识网：，增长医学知识。864.7735凝血素第七因子检测和凝血试验

14、prothrombin-proconvertin test and thrombotest864.7750凝血素时间检测prothrombin time test864.7825镰状细胞检测sickle cell test864.7875凝血酶时间检测thrombin time test864.7900促凝血酶原激酶生成检测thromboplastin generation test864.7925局部促凝血酶原激酶时间检测partial thromboplastin time testsi亚部血液学试剂(hematology reagents)864.8100大具窍蝮蛇试剂bothrops

15、atrox reagent864.8150细胞指数定标器calibrator for cell indices864.8165血色素或血球容积测量定标器calibrator for hemoglobin or hematocrit measurement864.8175血小板计数定标器calibrator for platelet counting864.8185红细胞和白细胞计数定标器calibrator for red cell and white cell counting864.8200血细胞稀释器blood cell diluent864.8500淋巴细胞分离介质lymphocyte

16、 separation medium864.8540红细胞溶解试剂red cell lysing reagent864.8625血液学质量控制混合剂hematology quality control mixture864.8950拉塞尔蛇毒试剂russell viper venom reagentj亚部在生产血液及血液制品的机构中使用的产品(products used in establishments that manufacture blood and blood products)864.9050血库供应品blood bank supplies864.9100用于收集和处理血液及其成分

17、的空容器empty container for the collection and processing of blood and blood components864.9125真空辅助式血液收集系统vacuum-assisted blood collection system864.9145冷冻血液处理系统processing system for frozen blood864.9160体外诊断用非人类的血型物blood group substances of nonhuman origin for in vitro diagnostic use864.9175血型和抗体自动检测系统a

18、utomated blood grouping and antibody test system864.9185血型鉴定观察箱blood grouping view box864.9195血液混合装置和血液称量装置blood mixing devices and blood weighing devices864.9205血液和血浆加温装置blood and plasma warming device864.9225体外诊断用细胞冷冻设备和试剂cell-freezing apparatus and reagents for in vitro diagnostic use864.9245自动血细

19、胞分离器automated blood cell separator864.9275体外诊断觲饫胄幕?br /blood bank centrifuge for in vitro diagnostic use864.9285免疫血液学用自动细胞洗涤离心机automated cell-washing centrifuge for immuno-hematology864.9300自动库姆斯氏试验系统automated coombs test systems864.9320用于比重测定的硫酸铜溶液copper sulfate solution for specific gravity determ

20、inations864.9400稳定酶溶液stabilized enzyme solution864.9550外源凝集素和保护素lectins and protectins864.9575用于血小板浓缩物储存的环境舱environmental chamber for storage of platelet concentrate864.9600体外诊断用增效剂potentiating media for in vitro diagnostic use864.9650血库试剂的质量控制试剂盒quality control kit for blood banking reagents864.970

21、0血液储存的电冰箱和冷藏机blood storage refrigerator and blood storage freezer864.9750热封装置heat-sealing device864.9875转移装置transfer set心血管医疗器械中英文对照a亚部总则（general provisions）870.1范围scope870.3有关上市前批准生效日期的要求effective dates of requirement for premarket approval870.9 联邦食品、药品和化妆品法（federal food, drug, and cosmetic act，fdc

22、a）第510（k）节的豁免限制limitations of exemptions from section 510(k) of the federal food, drug, and cosmetic act (the act)b亚部心血管诊断器械（cardiovascular diagnostic devices）870.1025心律失常探测器和警报器(苞括st段测量和警报)arrhythmia detector and alarm (including st-segment measurement and alarm)870.1100血压警报器 blood pressure alarm87

23、0.1110血压计算机blood pressure computer870.1120血压袖带blood pressure cuff870.1130非侵入式血压测量系统noninvasive blood pressure measurement system870.1140静脉血压计venous blood pressure manometer870.1200诊断觲苣诘脊?br /diagnostic intravascular catheter870.1210连续式冲洗导管continuous flush catheter870.1220电极记录导管或电极记录探针electrode recor

24、ding catheter or electrode recording probe870.1230光纤式血氧计导管fiberoptic oximeter catheter870.1240导流导管flow-directed catheter870.1250经皮导管percutaneous catheter870.1270腔内心音导管系统intracavitary phonocatheter system870.1280可操纵导管steerable catheter870.1290可操纵导管控制系统steerable catheter control system870.1300导管套管cath

25、eter cannula870.1310经皮插入导管用的血管扩张器vessel dilator for percutaneous catheterization870.1330导管导线catheter guide wire870.1340导管插入器catheter introducer870.1350导管球囊修理工具盒catheter balloon repair kit870.1360示踪微球体trace microsphere870.1370导管尖端封闭器catheter tip occluder870.1380导管探针catheter stylet870.1390套管针trocar870

26、.1425可编程的诊断用计算机programmable diagnostic computer870.1435预编程的单功能诊断用计算机single-function, preprogrammed diagnostic computer870.1450光密度计densitometer870.1650血管造影注器和注管angiographic injector and syringe870.1660指示剂注器indicator injector870.1670注器的注管制动器syringe actuator for an injector870.1750体外可编程起搏器脉冲发生器external

27、 programmable pacemaker pulse generator870.1800抽缩式输液泵withdrawal-infusion pump870.1875听诊器stethoscope870.1915热稀释探头thermodilution probec亚部心血管监测器械（cardiovascular monitoring devices）870.2050生物电位放大器和信号调节器biopotential amplifier and signal conditioner870.2060传感器信号放大器和调节器transducer signal amplifier and condi

28、tioner870.2100 心血管血液流量计cardiovascular blood flowmeter870.2120 血管外血流探头extravascular blood flow probe870.2300心脏监测器(苞括心率计和心率警报器)cardiac monitor (including cardiotachometer and rate alarm)870.2310尖端心动描记器(心振动图仪)apex cardiograph (vibrocardiograph)870.2320心冲击描记器ballistocardiograph870.2330 超声波心动图仪echocardio

29、graph870.2340心电图仪electrocardiograph870.2350 心电图仪导线转换接合器electrocardiograph lead switching adaptor870.2360心电图仪电极electrocardiograph electrode870.2370 心电图仪表面电极检测器electrocardiograph surface electrode tester870.2390心音图仪phonocardiograph870.2400心电向量图仪vectorcardiograph870.2450医用荫极线管显示器medical cathode-ray tub

30、e display870.2600信号隔离系统signal isolation system870.2620在线隔离监视器line isolation monitor870.2640便携式漏电流警报器portable leakage current alarm870.2675动脉搏动描记器oscillometer870.2700光电血氧计oximeter870.2710耳光电血氧计ear oximeter870.2750阻抗式静脉搏动描记器impedance phlebograph870.2770阻抗式体积描记器impedance plethysmograph870.2780水压式、气动式或光

31、电式体积描记器hydraulic, pneumatic, or photoelectric plethysmographs870.2800医用磁带记录器medical magnetic tape recorder870.2810纸质图表记录器paper chart recorder870.2840尖端心动描记传感器apex cardiographic transducer870.2850血管外血压传感器extravascular blood pressure transducer870.2860心音传感器heart sound transducer870.2870导管顶端压力传感器cathet

32、er tip pressure transducer870.2880超声式传感器ultrasonic transducer870.2890脉管闭塞传感器vessel occlusion transducer870.2900患者传感器和电极电缆(苞括连接器)patient transducer and electrode cable (including connector)870.2910频生理信号发送器和接收器radiofrequency physiological signal transmitter and receiver870.2920电话式心电图仪发送器和接收器telephone

33、electrocardiograph transmitter and receiverd亚部心血管修复器械（cardiovascular prosthetic devices）870.3250血管夹vascular clip870.3260腔静脉夹vena cava clip870.3300动脉栓塞器械arterial embolization device870.3375心血管内过滤器cardiovascular intravascular filter870.3450血管移植假体vascular graft prosthesis870.3470聚丙烯、聚对苯二甲酸乙癀或聚四氟乙烯制成的心内

34、补片或纱布intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene870.3535大动脉内球囊和控制系统intra-aortic balloon and control system870.3545心室旁路(辅助)器械ventricular bypass (assist) device870.3600体外起搏器脉冲发生器external pacemaker pulse generator870.3610植入式起搏器脉冲发生器implant

35、able pacemaker pulse generator870.3620起搏器导线接合器pacemaker lead adaptor870.3630起搏器发生器功能分析仪pacemaker generator function analyzer870.3640间接式起搏器发生器功能分析仪indirect pacemaker generator function analyzer870.3650起搏器聚合体网袋pacemaker polymeric mesh bag870.3670起搏器充电器pacemaker charger医学英语：870.3680心血管永久性或临时性起搏器电极cardi

36、ovascular permanent or temporary pacemaker electrode870.3690起搏器测试磁铁pacemaker test magnet870.3700起搏器程序器pacemaker programmers870.3710起搏器修复或替换材料pacemaker repair or replacement material870.3720起搏器电极功能检测器pacemaker electrode function tester870.3730起搏器维修工具pacemaker service tools870.3800瓣环成形术环annuloplasty r

37、ing870.3850颈动脉窦神经刺激器carotid sinus nerve stimulator870.3925心脏瓣膜替代品replacement heart valve870.3935心脏瓣膜假体支架prosthetic heart valve holder870.3945心脏瓣膜假体筛选器prosthetic heart valve sizere亚部心血管手术器械（cardiovascular surgical devices）870.4075心肌膜炎活组织检查器械endomyocardial biopsy device870.4200心肺旁路附属设备cardiopulmonary

38、bypass accessory equipment870.4205心肺旁路气泡探测器cardiopulmonary bypass bubble detector870.4210心肺旁路血管导管、套管或管路cardiopulmonary bypass vascular catheter, cannula, or tubing870.4220心肺旁路心肺机控制台cardiopulmonary bypass heart-lung machine console870.4230心肺旁路消泡器cardiopulmonary bypass defoamer870.4240心肺旁路热交换器cardiopu

39、lmonary bypass heat exchanger870.4250心肺旁路温度控制器cardiopulmonary bypass temperature controller870.4260心肺旁路动脉血过滤器cardiopulmonary bypass arterial line blood filter870.4270心肺旁路心切开术抽吸管路血液过滤器cardiopulmonary bypass cardiotomy suction line blood filter870.4280心肺旁路前过滤器cardiopulmonary prebypass filter870.4290心肺

40、旁路接合器、旋塞阀、汇流管或配件cardiopulmonary bypass adaptor, stopcock, manifold, or fitting870.4300 心肺旁路气体控制装置cardiopulmonary bypass gas control unit870.4310心肺旁路冠状动脉压力计cardiopulmonary bypass coronary pressure gauge870.4320心肺旁路脉动流发生器cardiopulmonary bypass pulsatile flow generator870.4330心肺旁路即时血气监测仪cardiopulmonary

41、 bypass on-line blood gas monitor870.4340心肺旁路液面自动检测监视器和/或控制器cardiopulmonary bypass level sensing monitor and/or control870.4350心肺旁路氧合器cardiopulmonary bypass oxygenator870.4360非滚筒型心肺旁路血液泵nonroller-type cardiopulmonary bypass blood pump870.4370滚筒型心肺旁路血液泵roller-type cardiopulmonary bypass blood pump870

42、.4380心肺旁路泵速度控制器cardiopulmonary bypass pump speed control870.4390心肺旁路泵管路cardiopulmonary bypass pump tubing870.4400心肺旁路血液储存器cardiopulmonary bypass blood reservoir870.4410心肺旁路内嵌式血气传感器cardiopulmonary bypass in-line blood gas sensor870.4420心肺旁路心切开术返回吸管cardiopulmonary bypass cardiotomy return sucker870.44

43、30心肺旁路心脏内抽吸控制器cardiopulmonary bypass intracardiac suction control870.4450血管夹vascular clamp870.4475外科手术血管扩张器surgical vessel dilator870.4500心血管手术器具cardiovascular surgical instruments870.4875管腔内动脉剥离器intraluminal artery stripper870.4885体外静脉剥离器external vein stripperf亚部 心血管治疗器械（cardiovascular therapeutic

44、devices）870.5050患者照料吸引装置patient care suction apparatus870.5150栓子切除导管embolectomy catheter870.5175房隔造口导管septostomy catheter870.5200体外心脏挤压器external cardiac compressor870.5225体外反搏装置external counter-pulsating device870.5300dc除颤器(苞括除颤板)dc ear，nose，and throat devices耳鼻喉医疗器械中英文对照a亚部总则（general provisions）874

45、.1范围scope874.3有关上市前批准生效日期的要求effective dates of requirement for premarket approval874.9 联邦食品、药品和化妆品法（federal food, drug, and cosmetic act，fdca）第510（k）节的豁免限制limitations of exemptions from section 510(k) of the federal food, drug, and cosmetic act (the act)b亚部诊断器械（diagnostic devices）874.1050听度计audiomet

46、er874.1060听力测试用听音室acoustic chamber for audiometric testing874.1070短增量灵敏度指数(sisi)适配器short increment sensitivity index (sisi) adapter874.1080听度计校准装置audiometer calibration set874.1090听觉阻抗检测器auditory impedance tester874.1100听力测试用耳机垫earphone cushion for audiometric testing874.1120听力测试用电子噪声发生器electronic n

47、oise generator for audiometric testing874.1325舌动电流描记器electroglottograph874.1500味觉计gustometer874.1800空气或水热量刺激器air or water caloric stimulator874.1820外科神经刺激器/定位器surgical nerve stimulator/locator874.1925托因比诊断管toynbee diagnostic tubec亚部 保留（reserved）d亚部修复器械（prosthetic devices）874.3300助听器hearing aid874.33

48、10助听器校准器与分析系统hearing aid calibrator and analysis system874.3320集体助听器或集体听觉训练器group hearing aid or group auditory trainer874.3330主助听器master hearing aid874.3375电池驱动的人工喉battery-powered artificial larynx874.3400耳鸣遮蔽器tinnitus masker874.3430中耳铸模middle ear mold874.3450局部听小骨置换假体partial ossicular replacement prosthesis874.3495完整听小骨置换假体total ossicular replacement prosthesis874.3540听小骨置换手术用假体修复器具prosthesis modification instrument for ossicular replacement surgery874.3620耳鼻喉合成聚合物材料ear, nose, and throat synthetic polymer material874.