医疗器械临床评估_中英文翻译
常用医学标准的中英文术语翻译
常用医学标准的中英文术语翻译医学标准术语的翻译对于医学界的交流和研究至关重要。
准确地翻译这些术语可以避免误解和混淆，确保专业信息的传递准确无误。
以下是一些常见的医学标准术语的中英文翻译。
1. 临床试验 - Clinical Trial临床试验是一种为了评估新型药物、治疗方法或医疗器械而进行的研究。
这些试验通常包括对人体进行的细致观察和数据收集，以确定疗效和安全性。
2. 疫苗接种 - Vaccination疫苗接种是指通过注射、口服等方式给予人体疫苗，从而提高人体免疫系统对某种疾病的抵抗力。
3. 随机对照试验 - Randomized Controlled Trial (RCT)随机对照试验是一种实验设计，将受试者随机分配到接受不同处理或对照组的不同条件下观察疗效。
4. 细胞培养 - Cell Culture细胞培养是指在实验室中人工创造一种类似于体内环境的培养条件，以培养和研究生物体的细胞。
5. 模拟人体实验 - In Vivo Experiment模拟人体实验是指在活体动物身上进行的实验，以评估药物、治疗方法或其他治疗干预措施的疗效和安全性。
6. 病理研究 - Pathological Research病理研究是通过对病理标本进行组织学、细胞学或分子学等分析，以诊断和研究疾病的方法。
7. 累及人数 - Incidence累及人数是指在一定时间内发生某种疾病或事件的数量，通常以每一万或每一百万人为单位。
8. 重大不良事件 - Adverse Event (AE)重大不良事件是指与药物治疗或其他干预措施相关的严重不良反应或意外事件，可能导致严重的身体伤害甚至死亡。
9. 生物等效性 - Bioequivalence生物等效性是指在给予相同剂量的药物后，在体内的吸收、分布、代谢和排泄等动力学过程中的相似性。
10. 患病率 - Prevalence患病率是指某一特定人群中患有某种疾病的比例或频率，通常以百分比表示。
《医疗器械临床试验方案》(节选)汉译英翻译实践报告
《医疗器械临床试验方案》（节选）汉译英翻译实践报告《医疗器械临床试验方案》（节选）汉译英翻译实践报告摘要：本报告是对《医疗器械临床试验方案》的节选内容进行汉译英的翻译实践。
通过对原文的解读和理解，结合专业知识和翻译技巧，对各种医疗器械临床试验方案中的术语、用语和语言表达进行翻译实践。
本报告旨在总结并分析翻译过程中的问题和技巧，提高翻译质量和翻译能力。
一、引言医疗器械临床试验方案是医疗器械临床试验的重要文件，用于规范医疗器械临床试验的设计、实施和分析过程。
对于这类文献的翻译，需要准确理解和转换原文中的专业术语和句子结构，保持文档的科学性和可读性。
二、翻译实践过程1. 术语翻译在翻译过程中，遇到了许多医学术语的翻译问题。
针对这些术语，我们首先进行了查阅相关文献和翻译工具的工作。
同时，还结合自身的医学专业知识进行适当的解释和转化。
例如，“医疗器械临床试验”我们翻译为“Clinical Trial of Medical Devices”。
2. 句子结构翻译句子结构在医疗器械临床试验方案中通常较为复杂，需要在保持原文意思的前提下改写成英文句子。
在这个过程中，我们注重语法的准确性和句子的流畅性。
例如，“试验组和对照组的受试者之间进行随机分组”的翻译为“Subjects in the test group and the control group were randomly assigned”。
3. 语言表达翻译语言表达是医疗器械临床试验方案中非常重要的一部分。
在翻译过程中，需要保持原文的科学性和严谨性。
同时，还要注意语言的简洁和流畅。
例如，“治疗期间如发生严重不良事件应立即停止试验。
”的翻译为“Clinical trial should be immediately discontinued if any serious adverse events occur during treatment”。
三、问题总结与分析在翻译实践过程中，我们遇到了一些问题，针对这些问题我们进行了总结和分析：1. 术语翻译准确性医学术语翻译的准确性对于文档的科学性和专业性至关重要。
医疗设备英语中英对照
医疗设备英语中英对照1 Myo-electric potential /evoked potential meter肌电/诱发电位仪2 fetal monitor胎儿监护仪3 digital imaging colposcope 数字成像阴道镜4 patient monitoring system 监护系统5 Coblation Plasma Surgery System低温等离子消融治疗仪6 IF Interference currency therapeutic Unit中频干扰电治疗仪7 Central Monitoring System中央监护系统8 Portable multi-parameter monitor便携式多参数监护仪9 MRI(magnetic resonance imaging) system磁共振成像系统10 CT （Computed (axial) Tomography）计算机X线断层摄影术11 X-ray Machine X射线机12 Color Ultrasonic 彩色超声波13 permanent-magnet open MRI system永磁开放式磁共振成像装置14 non-eddy current magnet无涡流磁体15 dynamic ECG动态心电图16 Spiral CT Scanner螺旋CT扫描机17 Full-body CT 全身CT机18 Open bore MR开放口径磁共振19 super high-field MRI超导高场20 Rotating /Rotary Viscometer 旋转式粘度计21 medical testing instrument and equipments 医用检测仪器及设备22 Bechtop超净工作台23 hemorrheology血液流变学24 Platelet Aggregation/Coagulation Analyzer血小板聚集凝血因子分析仪25 Blood Cell Deformation/Aggregation Analyzer血细胞变形/聚集测试仪26 Urine Sediments Microanalyzer尿沉渣显微分析仪27 blood flow rheometer 血流变仪28 X-ray diagnostic equipment X射线诊断设备29 Dental units 牙科仪器30 large-scale angiocardiography system 大型血管造影31 intervention treatment system介入治疗系统32 HF digital Gastrointestinal diagnostic system高频数字胃肠诊断系统33 direct digital imaging system直接数字成像系统34 Doppler spectrum analyzer 多普勒频谱分析器35 Computed & Remote-controlled X-ray diagnostic machine程控遥控医用诊断X射线机36 Magnetic Resonance Imaging System磁共振成像系统37 Comprehensive Dental unit牙科综合治疗机38 Autogenous Blood Recovery Unit自体血液回收机39 remote sensing 遥感40 telemetering 遥测41 He & Ne Laser intravascular irradiation therapeutic unit氦氖激光血管内照射治疗仪42 disposable optical fiber needle一次性使用光纤针43 semiconductor laser therapeutic unit, 半导体激光治疗仪44 optical fiber couplers光纤耦合器45 Laser Sitz bath chair 激光坐浴机46 low- intensity He[-Ne laser intravascular irradiation therapeutic unit47 低强度氦氖激光血管内照射治疗仪48 dressing 敷料49 Disposable Sterile Injector一次性使用无菌注射器50 Disposable venous Needle一次性使用静脉输液针51 Disposable Delivery Kit(operation package ,induced abortion) 一次性使用产包（手术包，人流包）52 Disposable mask and cap一次性口罩，帽子53 Disposable Sterile Hypodermic Needle一次性使用无菌皮下注射针54 Disposable Infusion Set一次性使用输液器55 disposable surgical pad一次性手术洞巾56 disposable surgical gown一次性使用手术衣服57 Gauze Bandage纱布绷带58 medical cotton bud医用棉签59 Universal Operating Table多功能手术床60 intervention treatment介入诊疗手术床61 Catheterization Operating Table 导管手术台62 Microsurgical Operating Table显微外科手术床63 Orthopedics Operating Table骨科手术床64 Orthopedics Navigation Operating Table骨科导航手术床65 carbon fibre material碳纤维复合材料66 Catheterization table 导管台67 catheter guide 导尿管导引器，68 catheter introducing forceps 麻醉导管导引钳.69 catheterization 导管插入术.70 catheterization table 导管台.71 catheter mandrin 导尿管导引针.72 catheter needle 导管针73 go-cart 病人移送车74 360°Rotatory Digitalized Cradle 360度可旋转数字摇篮床75 digital perspective bed 数字透视床76 infrared mammary diagnostic device (portable) 红外乳腺检查仪轻便型77 Infrared, B-ultrasonic mammary diagnostic systems红外B超联合乳腺诊断系统78 medical image-processing system医学影像处理系统79 mammary treatment unit乳腺治疗仪80 Emission Computed Tomography发射体层成像81 Single Photon Emission Computed Tomography单光子断层造影SPECT82 Positron tomography正子断层造影设备83 transmission computed tomography透射式计算机断层（TCT/XCT）84 computerized cerebrovascular comprehensive therapeutic unit 电脑血管综合诊断仪85 line array线阵86 foldaway翻盖87 concave array凹阵88 convex array凸阵89 trolley推车90 Laser therapeutic unit激光治疗仪91 Injection Pump注射泵92 Insufflator气腹机93 single-lens photography/video system单镜片摄像系统94 halogen cold light source 卤素冷光源95 pulmonary function testing system肺功能测量系统96 automatic pulmonary function analyzer自动分析肺功能仪97 HF electrotome高频电刀98 Spirometers 肺活量计99 Spectrophotometer分光光度计100 vertical purified operating table垂直净化工作台101 disk polarimeter圆盘旋光仪102 refractometers折射仪103 Centrifuges离心机、104 spectrophotofluorometer荧光分光光度计105 Constant temperature &freezing microtome恒温冷冻切片机106 infrared elliptical polarized spectrograph红外椭圆偏振光谱仪107 Laser Hemacytometer 激光血球计数仪108 Fluorophotometer荧光光度计109 fluoroscope 荧光屏110 converted biological microscope倒置生物显微镜111 biological microscope with Color T V Screen彩色电视生物显微镜112 biological microscope生物显微镜113 Lab biological microscope实验室生物显微镜114 Transmitted Polarization Microscope透射偏光显微镜115 Metallurgical Phase Microscope大型金相显微镜光学系统116 biological microscope 生物显微镜117 cryostats低温控制器118 stereoscopic microscope立体显微镜119 aerial survey instruments 航测仪器120 Microwave Therapeutic Unit微波治疗仪121 Radionuclide activity measuring equipment放射性核素活度测量仪122 Battery Automatic Testing Equipment自动电池测试仪123 X-ray cassette X射线暗盒124 X-ray tube X射线球管125 X-ray protective clothes X射线防护衣126 Transparent protective screen 全透明型防护屏127 X-ray intensifying screen X射线增感屏128 automatic film-developing machine自动洗片机。
医疗器械不良事件监测和再评价_英文
医疗器械不良事件监测和再评价_英文Monitoring and Re-evaluation of Adverse Events in Medical DevicesIntroduction:Medical devices play a crucial role in diagnosing, treating, and preventing diseases or medical conditions. However, like any other technology, medical devices can have flaws or unforeseen risks that pose a threat to patients' health and safety. To ensure patient safety and improve the quality of medical devices, monitoring and re-evaluation of adverse events are essential. This essay will discuss the importance of monitoring adverse events in medical devices, the current regulatory framework and reporting systems, and the implications for patient safety.Importance of Monitoring Adverse Events:Monitoring adverse events in medical devices is crucial for multiple reasons. Firstly, it allows manufacturers andregulatory authorities to identify potential safety concerns or inadequacies in the design, manufacturing, or use of a device. This information can then be used to make necessary improvements or modifications to enhance the device's safety profile.Current Regulatory Framework and Reporting Systems:In many countries, regulatory bodies require manufacturers and healthcare professionals to report adverse events related tomedical devices. These regulatory frameworks aim to create a transparent and accountable system for monitoring and evaluating adverse events.For instance, in the United States, the Food and Drug Administration (FDA) oversees the reporting system known as the Medical Device Reporting (MDR) program. Under this program, manufacturers, importers, and certain user facilities are required to report any serious injuries, deaths, or device malfunctions to the FDA. Additionally, the FDA maintains the Manufacturer and User Facility Device Experience (MAUDE) database, which allows healthcare professionals and the public to access adverse event reports and track device performance.Implications for Patient Safety:Monitoring and re-evaluation of adverse events in medical devices have significant implications for patient safety. By identifying adverse events, regulatory authorities can assess the risk-benefit profile of devices and take necessary actions to mitigate risks. This may include issuing safety alerts, updating labeling requirements, or even removing unsafe devices from the market.Conclusion:Monitoring and re-evaluation of adverse events in medical devices are critical in ensuring patient safety and maintaining the quality of healthcare. Through robust reporting systems andregulatory frameworks, healthcare professionals, regulatory authorities, and manufacturers can identify potential safety concerns, take necessary actions to mitigate risks, and enhance the overall safety profile of medical devices. By doing so, patients can have greater confidence in the devices used to diagnose, treat, and improve their health.。
医疗器械英语词汇
最牛英语口语培训模式：躺在家里练口语，全程外教一对一，三个月畅谈无阻！洛基英语，免费体验全部在线一对一课程：/（报名网址）医疗器械英语词汇今天洛基小编给大家带来一些医疗器械英语的词汇。
我们即使不出国，学了这些词汇会发现国内的一些英译真是搞笑死啦！大家快来纠纠错吧！医用辐射设备：medical radiological equipment自动纸塑包装机automatic packer生物安全柜Bio-safety Cabinet一次性使用输液器disposable infusion set眼罩eyeshade副作用ADVERSE EFFECT不良反应ADVERSE REACTION审理部门（指FDA）AGENCY简化新药申请ANDA（ABBREVIATED NEW DRUG APPLICATION）动物试验ANIMAL TRIAL存档用副本ARCHIVAL COPY批量生产；分批生产BATCH PRODUCTION生产批号记录BATCH PRODUCTION RECORDS洛基英语是中国英语培训市场上的一朵奇葩，是全球已被验证的东方人英语学习的最佳模式。
洛基英受益BENIFIT（S）（美国）联邦法规CFR（CODE OF FEDERAL REGULATION）临床试验CLINICAL TRIAL食用补充品Dietary supplement药物产品DRUG PRODUCT原料药DRUG SUBSTANCE出口药申请（申请出口不被批准在美国销售的药品）EPA（EXPORT APPLICATION）确定的名称ESTABLISHED NAME（美国）食品药品管理局FDA（FOOD AND DRUG ADMINISTRATION）非专利名称GENERIC NAME人工晶体：IOL三片式人工晶体：3 piece IOLs磨床：Polishing benches灭菌设备：Sterilizing equipment.推注器：Injectors亲水性：hydrophilic疏水性：hydrophobic医用高分子：biomedical polymer高分子粘弹性：polymer viscoelasticity医用脱脂棉：medical absorbent cotton医用垃圾：medical garbage洛基英语是中国英语培训市场上的一朵奇葩，是全球已被验证的东方人英语学习的最佳模式。
【医学英语】耳鼻喉医疗器械中英文对照
【医学英语】耳鼻喉医疗器械中英文对照Ear，Nose，and Throat Devices耳鼻喉医疗器械中英文对照A亚部――总则（General Provisions）874.1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Audiometer874.1060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 set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 noise 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）助听器Hearing Aid874.3310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 prosthesis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 material874.3695颚植入面部假体Mandibular implant facial prosthesis874.3730喉假体(Taub设计)Laryngeal prosthesis (Taub design)874.3760球囊切开钉(科迪钉)Sacculotomy tack (Cody tack)874.3820内淋巴分流器Endolymphatic shunt874.3850带阀门的内淋巴分流管Endolymphatic shunt tube with valve874.3880鼓膜穿刺管Tympanostomy tube874.3900鼻扩张器Nasal dilator带半渗透膜的鼓膜穿刺管Tympanostomy tube with semipermeable membrane874.3950经皮空气传导助听器系统Transcutaneous air conduction hearing aid systemE亚部――手术器械（Surgical Devices）874.4100鼻出血球囊Epistaxis balloon874.4140耳鼻喉圆头锉Ear, nose, and throat bur874.4175鼻咽导管Nasopharyngeal catheter874.4250耳鼻喉电动或气动手术钻Ear, nose, and throat electric or pneumatic surgical drill874.4350耳鼻喉光纤光源与传输体Ear, nose, and throat fiberoptic light source and carrier874.4420耳鼻喉手动手术设备Ear, nose, and throat manual surgical instrument874.4490耳鼻喉科用氩激光器Argon laser for otology, rhinology, and laryngology874.4500耳鼻喉显微手术二氧化碳激光器Ear, nose, and throat microsurgical carbon dioxide laser874.4680气管镜(柔性或刚性)及附件Bronchoscope (flexible or rigid) and accessories874.4710食管镜(柔性或刚性)及附件Esophagoscope (flexible or rigid) and accessories874.4720纵隔镜及附件Mediastinoscope and accessories874.4750喉动态镜Laryngostroboscope874.4760喉动态镜(柔性或刚性)及附件Nasopharyngoscope (flexible or rigid) and accessories874.4770耳镜Otoscope874.4780鼻内夹板Intranasal splint874.4800骨粒收集器Bone particle collectorF亚部――治疗器械（Therapeutic Devices）874.5220耳鼻喉给药装置Ear, nose, and throat drug administration device874.5300耳鼻喉检查与治疗装置Ear, nose, and throat examination and treatment unit874.5350抽吸式抗窒息装置Suction antichoke device874.5370抗窒息夹具Tongs antichoke device874.5550电动鼻清洗器Powered nasal irrigator874.5800鼻外夹板External nasal splint874.5840治疗口吃装置Antistammering device原文来自必克英语/topic-3898.html。
医疗器械类英语及其缩写
医疗器械类英语及其缩写DC （direct current）直流电DAMPER 阻尼器DGC (degaussing coil）消磁线圈DL （delay line ) 延时线DRIVE 激励、推动DRIVE TRANSF 推动变压器DY (deflection yoke）偏转线圈EHT （extra —high tension）极高压EMERGENCY-急停装置ERROR AMP （error amplifier) 误差电压放大器E—W CORRECTION（east — west correction) 东西向校正FBT (fly back transformer) 逆程变压器FILTER 滤波器FLIP FLOP 双稳态触发器FIYEACK BLANKING 回扫消隐FOCUS 焦点FOCUS VR (focus variable rheostat) 聚焦电位器f。
(fuse) （fuse）保险丝GANTRY-机架G (green）绿色的GND （ground) 接地GREEN CUT OFF 绿枪截止调节GREEN OUT 绿色输出GREY 灰度G - Y MATRIX （G - Y )矩阵H。
BLK （horizontal blanking）行消隐H.DY （horizontal deflection yoke) 行偏转线圈HFC (high frequency choke) 高频扼流圈H.HOLD （horizontal hold) 行同步调节H （L）.DRIVE （horizontal driver）行推动放大器HLIN （horizontal linearity）行线性H（L）OUT BOARD 行输出板H 。
M(module）厚膜电路HOR AFC （horizontal automatic frequency control) 行自动频率控制HOR DRIVE TRANS 行激励变压器HORIZONTAL 行（水平）扫描部分HORIZ O/P （horizontal out put ) 行脉冲输出H.OSC（horizontal oscillator) 行振荡器H。
医疗器械医学仪器工程中英文对照外文翻译文献
中英文对照翻译Present status and problems of domestic medical instrument engineering. Biomedical EngineehngIn recent years considerable progress has been achieved in domestic medical instrument engineering. Many plants and scientific-research organizations of machine-making and the defense industry have changed their profile toward production of medical equipment.However, medical equipment often meets a reluctant market because of funding cuts in health services. Medical organizations often cannot satisfy even their basic requirements for diagnostic and therapeutic devices. Also, health service organizations tend to buy foreign rather than domestic medical equipment because the former are easily available on the domestic market and prices for both are comparable because of inflation.The transition to a market economy in Russia has had substantial impact on the relations between domestic manufactur- ers and consumers of medical devices. The spectrum and quality of available items has been significantly extended in recent years. It should be also noted that available models of medical devices are continuously updated, which makes them sufficiently competitive.Representative information on the updating dynamics of domestic medical equipment is summarized in Table 1. The data were provided by the VNIIMP-VITA Joint-Stock Company, which compiles a data bank of such information.Generally, new items account for 37% of total production of medical devices. Routinely produced devices (duration of production, 2-5 years) account for 28%. Medical devices of long-term production (5-10 years) account for 17% and obsolete nomenclature (devices produced for more than 10 years) accounts for 18%.It is seen from Table 1 that in recent years there has been considerable progress in the updating of production of medical equipment. For example, according to the VNIIMP-VITAJoint-Stock Company, the share of the items that have been produced for no longer than 5 years in 1988 did not exceed 35%, while now it is 65%. For the items that have been produced for more than 10 years such shares are 40 and 18%, respectively.Updating of produced medical devices was encouraged by the increase in the number of designers and manufacturers, particularly those of former defense industry facilities. In collaboration with foreign partners they set up joint ventures for producing medical equipment.Analysis of the updating of the various groups of medical equipment is of substantial interest.It is seen from Table 1 that detoxication devices contribute dominantly to the group of items that have been updated within the standard period of up to 5 years (100% of production, including modern devices for hemodialysis and hemosorption).Comparatively high updating indices are observed for devices for functional diagnosis: 72% of these devices have been produced for no longer than 5 years, and obsolete devices account for only 9% of total production. However, it should be noted that although production of some obsolete devices has been terminated, equipment of similar functional capacity is still urgently needed.Relatively low updating indices are observed among the devices for intensive care and resuscitation: 16% of new items and comparatively many obsolete devices (26%). Among new models apparatuses for artificial lung ventilation are worth mention. However, some apparatuses, which have been developed long ago are still on the market because they have good performance, are quite reliable, and still are in demand. This reduces the updating index of the group as a whole.All-Russian Scientific-Research Institute for Medical Instrument Engineering, Rusaian Academy of Medical Sciences (VNIIMP-VITA Joint-Stock Company), Moscow. Translated from Meditsinskaya Tekhnika, No. 1, pp. 4-9, January-February, 1996. Original article submitted August 23, 1995.0006-3398/96/3001-0001515.00 y Plenum Publishing CorporationTABLE 1. Updating of Basic Groups of Medical Devices and Apparatuses (% of total nomenclature)The lowest updating indices are observed for devices for examining a patient's body structures.These are: ophthalmological, otolaryngological, and anthropometric devices, endoscopes, etc. Theshare of obsolete devices is high (44%), while the devices which have been produced for no more than 5 years account for only 20% of total production.It should be noted that these results on medical equipment updating are important generalestimates, although they do not take into consideration specific achievements and shortcomings in the production of individual items. Therefore, some corresponding amendments are required.Our survey of available information, including the VNIIMP-VITA Joint-Stock Company data bank, materials presented at various exhibitions, and recent literature, shows that domestic medical industry has developed a number of original medical devices and apparatuses which were designed to replace similar obsolete models. However, many types of important and necessary medical devices still do not meet contemporary requirements, and some types of devices are not produced at all.For example, in recent years production of some sophisticated medical devices (apparatuses for intensive care, resuscitation, and anesthesiology; devices for artificial lung ventilation, respiratory narcosis devices, extracorporeal circulation) significantly rose, particularly at the former defense industry facilities, and their quality has been significantly improved. The functional performance of the devices is generally on par with foreign analogs.Perfusion units have also been improved and their production has expanded. This allowed the demand of the health service organizations for such equipment to be satisfied completely. Modern domestic hemodialysis devices (Renart-10, Renan- 10RT, etc.) have been developed and brought into wide clinical practice.The development and production of diagnostic magnetic resonance imaging systems (Obraz-3, TOROS) are considerable breakthroughs in domestic medical industry. This substantially extends diagnostic capacities of many health service organizations and provides them with topical diagnosis previously unavailable domestically, although it is quite common in developed foreign countries.Domestic medical industry has begun production of pulse oximeters; these are of particular use in surgery and resuscita-tion. This bridged a substantial gap in the spectrum of available domestic medical devices.The Bilitest bilirubin meter, which has been recently developed and produced in Russia, fully meets the requirements of maternity and children's hospitals in devices for diagnosing jaundice.A high-standard radioimmunochemical laboratory was opened at the VNIIMP-VITA Joint-Stock Company to supply customers with necessary radioimmunochemical assay kits.A number of high-quality medical devices and instruments have been developed at the electronic industry plants and institutes. The following devices are particularly worthy of mention artificial cardiac valves of the Emitron Plant, which are on par with the best foreign analogs;pH meters (Istok State Scientific-Manufacturing Association);Ikar long-term (up to 24 h) cardiomonitors with electronic memory (Kometa Central Scientific-Manufacturing Association);radiothermographs and racliothermoscopes for detecting deeply located thermal fields in the human body (Oktyabr' Manufacturing Association and Design Bureau for Ecological and Medical Equipment);original thermal imaging system (Institute of Radioelectronics and Automatics, Russian Academy of Sciences; OPTROS, Ltd.);original computer-assisted system Cardiac Rhythms for monitoring oatient condition and pulsimetry (Institute of Chemical Physics, Russian Academy of Sciences; Ekos, Ltd.);video system for endoscopic imaging (Zenit Scientific-Manufacturing A~sociation; Elektron Scientific-Research and Manufacturing Association);streamlined technology for producing disposable and reusable syringes, injection needles, and surgical threads.A number of other problems of domestic medical instrument-making industry have been successfully solved in recent years.For example, the number and quality of therapeutic devices, particularly for laser therapy, is quite sufficient. Research studies are carried out by many organizations including former defense industry facilities. Technologies which have been developed for other purposes give fruitful results in medical industry.According to our data, more than 150 models of such medical devices have been developed over the last 5 years. Some 100 of them are commercially available. Although domestic medical devices are often superior ot foreign analogs in terms of working performance and they are definitely less expensive, many of them are not in short demand and are virtually not used.However, this activity in many other areas of medical instrument engineering cannot be considered as sufficiently successful and rational.It should be noted that many newly developed models of domestic medical devices compare unfavorably with foreign analogs. This is particularly the case for X-ray and ultrasonic devices, electrocardiographic monitors, laboratory equipment, etc. Nevertheless, according to the VNIIMP-VITA Joint-Stock Company databank, certain positive trends have been observed in recent years even in these areas. However, most problems still remain unsettled and the conditions required to solve them have not yet been established.It is important to note that the serially produced X-ray apparatus RUM-20 (Mosrentgen Joint-Stock Company) has been significantly updated. The updated model RUM-20M-SG312 is commercially available in combination with the Sapfir domestic image intensifier or an image intensifier of a French manufacturer. The Kruiz fiat image intensifier has been developed at the All-Russian Scientific-Research Institute for Medical Instrument Engineering in collaboration with MELZ Manufacturing Association and Mosrentgen Joint-Stock Company. This device is designed to replace existing fluorescent screens in the X-ray diagnostic apparatuses RUM-10, RUM-20, RUM-20M, and others. The use of the Kruiz image intensifier significantly increases image information content and allows threefold decrease in the radiation load on patients and medical personnel.The G 202-5 system for lit-par-lit raster imaging of patients in lying position has been developed at the Mosrentgen Joint-Stock Company. This device is commercially available with the PURS power source. It allows both manual and automatic X-ray photography and organ-oriented X-ray examination.The RTS-61 mobile X-ray video diagnostic apparatus has been developed at the Elektron Scientific-Research and Manufacturing Association. This device is designed to be used in surgery, orthopedics, and traumatology. Among the defense industry facilities which have reoriented their production to medical market the Scientific-Research Institute for Electromechanics (Istra) is worth mention. In collaboration with Phillips (Germany) and borrowing their technology and circuitry, the Institute for Electromechanics developed the Mammodiagnost mammographic scanner, which meets international standards of operating performance.The Rentgen-48 X-ray tomographic diagnostic systems with a rotary support table and the Rentgen-60 X-ray diagnostic systems with a remote control support table have been developed at the Sevkavrentgen Plant and received positive recognition by practicing physicians.The models of X-ray diagnostic devices listed above are examples of achievements of domestic medical industry.However, many important and significant problems of the development of domestic medical X-ray equipment remain unsettled, and it is unreasonable to expect that they will be solved in the foreseeable future unless special measures are taken.For example, the most common RUM-20 X-ray apparatuses with the Sapfir image intensifier are equipped with the obsolete X-ray image converter REP-1. To replace the REP-1 image converter, the Moscow Plant for Electronic Tubes has developed the Buer image converter of improved design. This device offers better image contrast, reduced clark background noise, and has an output fiberoptic window of improved design. However, the Buer image converter is not yet commercially available.Digital X-ray diagnostic devices are not yet commercially available from domestic manufacturers either.The Design Bureau for Medical Engineering in collaboration with Medtekh, Ltd. (Novosibirsk) have developed the Diaskan X-ray digital scanner. Serial production of this device is in progress at the Design Bureau for Medical Engineering.However, devices of sufficient quality are not yet commercially available.Domestic medical industry does not produce X-ray tomographs. Their production in Chelyabinsk has been suspended.Electrocardiographic monitors are very important devices for functional diagnosis. However, domestic medical industry fails substantially behind leading foreign manufacturers and there is a disproportion in the development and production of necessary devices and apparatuses. Many automatic systems for ECG processing, including syndromal diagnosis, have been developed, but they trove not been tested and are of little demand. However, simple three-channel electrocardiographs of mass- scale application are not produced by domestic manufacturers.Foreign manufacturers offer various ultrasonic scanners and sophisticated imaging systems. Domestic manufacturers produce only simple devices with manual sector-by-sector scanning and a few simplified models with linear electronic scanning.Some positive results have been achieved in the development of endoscopic devices. These achievements are mainly due to the collaboration between LOMO and some companies from Japan. However, even these devices require further improvement of quality and reliability.Although the level of production of domestic laboratory equipment has noticeably risen in recent years, it is still too little to meet the demand. The number of organizations involved in the development of such equipment has risen. However, the available devices are simple and have limited functional capacity. Many important devices (e.g., automatic analyzers and simple routine devices) are not produced at all.Devices for blood transfusion and preparing blood substitute solutions are still in short supply (40 million items have been produced, while the demand is 200 million). The demand in dialyzers and polymer infusion systems reaches 100 and 150 million items, respectively, although such systems are not produced at all.The correspondence between production and demand, quality and technical performance, and adequate testing of medical production are put in the forefront under conditions of a market economy. The problem of competition with foreign manufacturers is also quite important because of increasing import of medical equipment and reduced sale of the production of domesticmanufacturers. In this connection, the following circumstances should be taken into consideration.There is a considerable disproportion between production and demand of some groups of medical devices. For example, there is :~ huge surplus of laser therapeutic devices and their excessive development. Systems for syndromal electrocardiographic diagnosis, magnetotherapy, and electrostimulation are also in excessive supply. However, simple electrocardiographs, routine laboratory equipment, and some other ordinary but necessary devices of mass-scale application are not produced by domestic manufacturers. These disadvantages cause significant economic losses and present difficulties in the development of health service. Domestic and foreign experience show that these problems can be solved by adequate marketing, but this is in its infancy in the domestic medical industry.It should be noted that foreign companies place special emphasis on marketing and market research. They evaluate actual and pending demand as well as consumer requirements. The feedback between consumer and manufacturer gives valuable information on the improvement of the product quality and working performance. The marketing service in most leading companies is of paramount importance. The development of a new product often starts from marketing survey rather than from engineering or design research. Many domestic organizations of medical instrument engineering require cardinal measures for increasing the level of marketing.Testing of medical devices also requires substantial improvement. Considerable experience of foreign manufacturers of medical equipment should be taken into account. It should be noted, however, that this experience is often neglected by domestic manufacturers. Technical testing of medical equipment in foreign companies is usually carried out by independent laboratories which assess performance and quality. The specialists of the laboratories may also give recommendations for further improvement of the tested equipment. The basic goal of the testing is to check if the performance of the device matches its specifications and to conclude if the device can be used in medical organizations. However, the specialists of the laboratories usually go beyond this goal and issue comparative reviews of products of different companies. Such reviews contain the following information: description of tested device, its specifications, and price; results of technical testing, correspondence between specifications and actual performance, advantages and disadvan- tages, recommendations for improvement (if necessary);comparative analysis of similar devices and apparatuses produced by different manufacturers. Such analysis is usually concluded by a most preferable model, which is recommended to medical organizations on the basis of functional capacity, reliability, and economic reasons.In the USA, activity of testing laboratories is controlled by governmental, nongovernmental, and independent nonprofit organizations.In Russia, the problem of balance between the demand in medical devices, their production by domestic manufacturers, and import is of considerable importance.The opinion of the Head of the Department of Medical Industry, Russian Ministry of Health and Medical Industry, Yu. F. Doshchitsin, which was published in the weekly "Meditsinskii Biznes" (No. 9, 1995), is that the requirements of Russian medical market must be met by domestic devices, including products of high technology. Russian medicine should not rely on imported devices alone. We certainly agree with this opinion.The total volume of medical equipment purchased from abroad is presently several times greater than purchases from domestic manufacturers. This situation is definitely unacceptable. Cardinal measures are required to boost and stimulate economically domestic manufacturers ofmedical equipment. This is particularly important for manufacturers of life support systems and devices for military medicine.However, positive aspects of contacts with foreign manufacturers of medical equipment should not be disregarded. International cooperation is very common in foreign practice, but it is clearly insufficient in Russia.International cooperation in medical industry is particularly vital in such areas as computer technology, microprocessors, and electronic engineering. Lack of sufficiently high-quality domestic computers and microprocessors presents considerable problems in the development of sophisticated medical devices and apparatuses.In recent years a number of domestic organizations established joint ventures with leading foreign manufacturers of medical devices. These joint ventures produce high-technology devices on the basis of imported circuitry, modules, and individual finished units. For example, VNIIMP-VITA produces ultrasonic doppler scanners, Kursk Manufacturing Association Pribor in collaboration with Frezenius (Germany) produces mobile apparatuses for hemodialysis and hemosorption, LOMO and some companies from Japan established a joint venture for manufacturing flexible endoscopes of improved design, Moscow Manufac- turing Association EMA produces ultrasonic diagnostic devices, etc.It seems reasonable to continue and extend mutually profitable contacts between domestic and foreign manufacturers of medical equipment.Active participation and patronage of the Russian Ministry of Health and Medical Industry as well as the Russian Government and local authorities are needed to solve the problems of medical industry listed above and to implement programs of development and production of high-quality domestic medical devices.References[1] V. A. Viktorov，V. P. gundarov，A. P. yurkevich. Present status and problems of domestic medical instrument engineering. Biomedical Engineehng~ V oL 30, No. 1, 1996.[2]All-Russian Scientific-Research Institute for Medical Instrument Engineering, Rusaian Academy of Medical Sciences (VNIIMP-VITA Joint-Stock Company), Moscow. Translated from Meditsinskaya Tekhnika, No. 1, pp. 4-9, January-February, 1996. Original article submitted August 23, 1995.国内医学仪器工程的现状和存在的问题近年来，国内在工程医疗器械实现取得了很大进展。
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CLINICAL EVALUATION REPORT临床评估报告For Product: XXXX产品：XXXXDocument No. XXXXXXXX文件编号Version: 1.0版本:Date: 2015-11-24日期:Author:作者:Reviewed by:审阅:Approved by:批准:<Company><公司>Table of Content目录Page页码1. General details总述 (3)2. Description of the device and its intended application器械描述和预期用途.. 33. Intended therapeutic and/or diagnostic indications and claims预期治疗和/或诊断说明和要求 (3)4. Context of the evaluation and choice of clinical data types评估背景和临床数据类型的选择 (3)5. Summary of the clinical data and appraisal总结临床数据和评价 (4)6. Data analysis数据分析 (5)6.1. P erformance性能 (5)6.2. S afety安全 (5)6.3. P roduct Literature and Instructions for Use产品文献和使用说明 (5)7.Conclusions结论 (6)1. General details 总述State the proprietary name of the device and any code names assigned during device development. Identify the manufacturer(s) of the device.描述器械的商品名，以及在器械研发过程中使用的任何编码。
识别器械的生产商。
2. Description of the device and its intended application 器械描述和预期用途Provide a concise physical description of the device, cross referencing to relevant sections of the manufacturer’s technical information as appropriate. The description should cover information such as:materials, including whether it incorporates a medicinal substance (already on the market or new), tissues, or blood products;the device components, including software and accessories;mechanical characteristics; andothers, such as sterile vs. non-sterile, radioactivity etc.State the intended application of the device, single use/reusable; invasive/non invasive; implantable; duration of use or contact with the body; organs, tissues or body fluids contacted by the device.Describe how the device achieves its intended purpose.对该器械进行简明的物理描述，适当参照生产商技术信息的相关章节。
此描述应包含的信息，如：材料，包括是否含药（已经上市的或全新的）、组织或血液产品；器械组成，包括软件和附件；机械特征；和其他，如灭菌，非灭菌，放射能等等。
描述器械的预期用途，一次性使用/多次使用；侵入/非侵入；可植入；使用持续时间或与人体接触；器械接触的器官，组织或体液。
描述器械如何达到它的预期用途。
3. Intended therapeutic and/or diagnostic indications and claims预期治疗和/或诊断说明和要求State the medical conditions to be treated, including target treatment group and diseases.Outline any specific safety or performance claims made for the device描述使用时的医学条件，包括目标治疗群体和疾病。
概述器械的任何特殊安全或性能要求。
4. Context of the evaluation and choice of clinical data types评估背景和临床数据类型的选择Outline the developmental context for the device. The information should include whether the device is based on a new technology, a new clinical application of an existing technology, or the result of incremental change of an existing technology.The amount of information will differaccording to the history of the technology. Where a completely new technology has been developed, this section would need to give an overview of the developmental process and the points in the development cycle at which clinical data have been generated. For long standing technology, a shorter description of the history of the technology (with appropriate references) could be used. Clearly state if the clinical data used in the evaluation are for an equivalent device.Identify the equivalent device(s) and provide a justification of the equivalency, cross-referenced to the relevant non-clinical documentation that supports the claim.概述器械的发展历史。
内容应包括器械是否基于新技术，是否基于现有技术的新临床应用，或者是现有技术增量变化的结果。
根据该技术的历史，信息量将有所不同。
如果是一项全新技术发展起来，本章须概述发展过程和发展周期中产生临床数据的节点。
如果是常规技术，须简短描述该技术的历史（须适当引用）。
明确指出，评估中使用的临床数据是否来自等同器械。
识别等同器械，并给出等同的理由，参照相关非临床文献，以支撑观点。
State the Essential Requirements relevant to the device in question, in particular, any special design features that pose special performance or safety concerns (e.g. presence of medicinal, human or animal components) that were identified in the device risk management documentation and that required assessment from a clinical perspective.陈述有关讨论的器械的基本要求，特别是，任何导致特殊性能或安全特性（如药，人体或动物组织的使用）的特殊设计已经在器械风险管理文件中被识别过，并从临床的角度进行了必要的评估。
Outline how these considerations were used to choose the types of clinical data used for the evaluation. Where published scientific literature has been used, provide a brief outline of the searching/retrieval process, cross-referenced to the literature search protocol and reports.概述这些需要考虑的因素如何用来选择评估中用到的临床数据的类型。
如果引用已出版的科学文献，请简要描述检索/回溯过程，参照文献检索草案和报告。
5. Summary of the clinical data and appraisal 总结临床数据和评价Provide a tabulation of the clinical data used in the evaluation, categorised according to whether the data address the performance or the safety of the device in question. (Note: many individual data sets will address both safety and performance.) Within each category, order the data according to the importance of their contribution to establishing the safety and performance of the device and in relation to any specific claims about performance or safety. Additionally, provide a brief outline of the data appraisal methods used in the evaluation, including any weighting criteria, and a summary of the key results.提供一张评估中用到的临床数据的表格，按照数据是否关系到讨论的器械的性能或安全来分类。