BBM 译员术语库（内部使用）。使用下方搜索框可按英文或中文筛选。
未分类术语
| English | 中文 |
|---|---|
| COVER | 外针帽 |
| SHIELD | 内针帽 |
| Teardrop label | 针盖贴 |
| Single-use lenses for RESIGHT | 一次性使用眼科手术观察镜 |
| ISAAC catheter | 导引导管 |
监护与护理相关术语
| English | 中文 |
|---|---|
| Patient Monitor | 病人监护仪 |
| care area | 病区 |
| Across care areas | 跨病区 |
| neuromuscular transmission (NMT) | 神经肌肉传导 |
| arrhythmia | 心律失常 |
| 4-lead simultaneous arrhythmia analysis | 4导联同步心律失常分析 |
| Uninterrupted workflow | 连续的工作流程 |
| non-invasive blood pressure measurement | 无创血压测量 |
| sidestream | 旁流 |
| anesthetic agents agents |
麻醉气体 |
| venous stasis | 静脉阻滞 |
| NIBP venous stasis feature | NIBP静脉阻滞功能 |
| stasis pressure | 阻滞压 |
| venous cannulation | 静脉穿刺 |
| helping clinicians reduce failed attempts to locate the vein for venous cannulation | 有助于临床医生减少尝试静脉穿刺寻找静脉的失败次数 |
| e-module | E模块 |
| Rack/Slot | 插槽 |
| Frame | 插槽
模块箱 插件槽 插件箱 （酌情使用上述表达） |
| Module rack (integrated) | 模块插槽（集成式） |
| 2nd frame for additional modules connector | 第2个插件槽用于额外模块的连接器 |
| Additional second frame for up to two modules | 最多可加两个模块的第二插件箱 |
| two-slot parameter module frame | 双插槽模块箱 |
| B1X5-F2 Second Frame (optional) | B1X5-F2第二插件箱（选配） |
| B1X5-F2 frame | B1X5-F2插件槽 |
| Slot for a single module | 用于一个模块的插槽 |
| single frame | 单个插槽 |
| Single alarm overview menu to review and set alarm limits for all parameters | 一个报警概览菜单可查看和设置所有参数的报警限值 |
| Adequacy of Anesthesia parameters | 适宜麻醉参数 |
| automatic View on Alarm (AVOA) | 自动查看报警 |
| 12 waveforms | 12道波形 |
| patient acuity | 患者危重程度 |
| USB drive | U盘 |
| Uninterrupted workflow | 连续的工作流程 |
| Wave | 挥手 |
| Bed-to-bed communication | 隔床跨视 |
| Alarm | 报警 |
| Roving | 巡回 |
| spirometry | 肺功能测定 |
| Resolution | 分辨率 |
| 2 channel InvBP | 2通道InvBP |
| Asystole | 停搏 |
| Couplet | Couplet偶联 |
| Bigeminy | 二联律 |
| Accelerated Ventricular | 心室加速 |
| Trigeminy | 三联律 |
| Multifocal PVCs | 多源性室早 |
| A Fib | 房颤 |
| Missing beat | 心搏缺失 |
| Pause | 暂停 |
| Irregular | 不规则 |
| SV Tachy | 室上性心动过速 |
| Frequent PVCs | 频发室性早搏 |
| Frequent SVCs | 频发性室上性早搏 |
| Asystole, V Fib/V Tach, V Tach, Brady, FiO2 Low, EtO2 Low and FiN2O high | 停搏、室颤/室速、室性心动过速、心动过缓、FiO2低、EtO2低和FiN2O高 |
| Adult | 成人 |
| Ohm | 欧姆 |
| Pulse rate | 脉率 |
| APOD (Adaptive Probe Off Detection) | APOD（自适应探头脱落探测） |
| Oscillometric with step deflation | 采用阶梯式放气振荡法 |
| Numerics trend printout | 数值趋势打印输出 |
| customseries cycle time | 自定义序列循环时间 |
| MAP | 平均压 |
| hemodynamic measurement | 血流动力学测量 |
| From integrated hemodynamic measurement | 来自集成式血流动力学测量 |
| SPV (Systolic Pressure Variance) | 收缩压变异率 |
| PPV (Pulse Pressure Variance) | 脉搏压变异率 |
| PP (pulse pressure) | 脉压 |
| Networking services | 网络服务 |
| Connectivity to CIS / HIS through CARESCAPE Gateway | 通过CARESCAPE Gateway连接到CIS/HIS其它网络应用 |
| Clinical precision | 临床精密度 |
| Connectivity to | 连接到 |
| Direct Connectivity to EMR or 3rd party systems for numeric trend | 直接连接到EMR或第三方系统以获得数值趋势 |
| Gateway | Gateway |
| CARESCAPE Gateway | CARESCAPE Gateway |
| Bed to Bed window | 隔床跨视窗口 |
| Monitor alarms for up to view one bed from up to 2048 beds | 查看最多2048张病床中的一张病床的报警 |
| more than 1 beds alarming | 1张以上的病床报警 |
| Roving between units and beds | 在病房和病床之间巡视； |
| I/O peripherals | 输入/输出外围设备 |
| settings | 设置值 |
| import/export settings | 导入/导出设置值 |
| secondary clone display | 第二克隆屏 |
| Vitals | 生命指标 |
| Temp & CO | 体温和心输出量 |
| Neuro parameters | 肌松参数 |
| Vitals, IBP, Gases, Spirometry, Vent Settings, Temp & CO, Neuro parameters | 生命指标、IBP、气体、肺功能测量、通气设置值、体温和心输出量、肌松参数 |
| EtCO2 side-stream measurement, anesthetic agents and cardiac output | EtCO2旁流测量、麻醉气体和心输出量 |
| Remote printer with CARESCAPE Central Station | 通过CARESCAPE中心工作站的远程打印机 |
| V Fib/V Tach | 室颤/室速 |
| VTach rate range | 室性心动过速心率范围 |
| duration criteria for a sustainable VTach alarm | 持续性室性心动过速报警的持续时间标准 |
| separate configurability for low priority alarm volume and rhythm | 单独可配置性低优先级报警音量和节律 |
| Visual alarm | 视觉报警 |
| Red, yellow, cyan | 红、黄、青 |
| General alarm message | 一般报警消息 |
| Audio | 声音 |
| Pause | 暂停 |
| gesturebased audio pause | 手势声音暂停 |
| Gesture-based alarm silencing by simple hand waving in front of the monitor | 在监护仪前挥手，即可基于手势做报警静音 |
| General alarm message | 一般报警消息 |
| Up to | 多达 |
| Snapshot | 快照 |
| Full disclosure | 全息浏览 |
| Tab/page | 选项卡/页 |
| all ECG | 所有ECG |
| 72 hours with all waveform data | 2小时，包括所有波形数据 |
| Integrated link with alarm history | 集成链接报警历史 |
| Resp Rate | 呼吸频率 |
| History | 历史记录 |
| main screen | 主屏幕 |
| green tick | 绿色的钩 |
| red tick | 红色的钩 |
| Storage | 储存 |
| AC input | AC输入 |
| high capacity | 高容量 |
| Charging time | 充电时间 |
| Run time | 运行时间 |
| Ingress protection | 防护等级 |
| no fan inside for cooling | 内部无风扇散热 |
| alarm silencing | 做报警静音 |
| Alarm breakthrough | 报警突破 |
| Surgical Pleth Index (SPI) | 手术体积描记指数（SPI） |
| thermal recorder | 热敏记录仪 |
| Outbound HL7® | HL7®输出 |
| drop | 跌落 |
| lOC (level of consciousness) | LOC（意识水平） |
| Groups supported | 支持的参数分组 |
| Unit and bed name, alarm message, more than 1 beds alarming | 病房和病床名称、报警消息、1张以上的病床报警 |
| Synchronize device clock from an external NTP server | 通过外部NTP服务器同步设备时钟 |
| Supports secondary clone display | 支持第二克隆屏 |
| National Early Warning Score 2(NEWS2) | 国家早期预警评分2（NEWS2） |
| Modified Early Warning Score (MEWS) | 改良早期预警评分（MEWS） |
| Lithium Ion | 锂离子电池 |
| Spirometry and Vent settings from Carestation 6×0 | Carestation 6×0麻醉机的肺功能测量和通气设置值 |
| Remote printer with CARESCAPE Central Station | 通过CARESCAPE中心工作站的远程打印机 |
| Reproduction in any form is forbidden without prior written permission from GE. Nothing in this material should be used to diagnose or treat any disease or condition. Readers must consult a healthcare professional. | 未经GE HealthCare事先书面许可，禁止以任何形式复制。本材料中的任何内容都不应用于诊断 或治疗任何疾病或病症。读者必须咨询专业医疗保健人士。 |
| Not all products or features are available in all markets. Full product technical specification is available upon request. Contact a GE Healthcare Representative for more information. | 产品可能并非在所有国家和地区都可用。可根据客户要求提供完整的产品技术规格。 请联系 GE Healthcare 代表，了解更多信息。 |
| Data subject to change. | 相关数据可能随时变更。 |
BD Diabetes专用术语
| English | 中文 |
|---|---|
| Pen Needle | 注射笔针头 |
| Cover | 外针帽 |
| Shield | 内针帽 |
| Cannula | 针管 |
| Hub | 针座 |
| Tear drop label | 针座盖贴 |
| GE HealthCare Technologies Inc. | 通用电气医疗科技公司 |
| GE Pacific Private Limited. | 通用电气太平洋私人有限公司 |
| English | 中文 |
|---|---|
| Bunker cyclotrons | 非自屏蔽回旋加速器 |
| capsule transfer | 梭体传输 |
| Multi-curie production | 大量生产 |
| Capsule Handling Station | 梭体处理站 |
| target port | 靶端口 |
| pre-plated coin | 预镀靶片 |
| English | 中文 |
|---|---|
| action item | 行动项 |
| adverse event | 不良事件 |
| agenda | 日程 |
| associate | 员工 |
| audit | 审核 |
| audit action plan | 审核行动计划 |
| audit finding | 审核发现项 |
| Audit Lead | 审核领导 |
| audit objective | 审核目的 |
| Audit Owner | 审核负责人 |
| audit plan | 审核计划 |
| audit program | 审核项目 |
| Audit Program Manager | 审核项目经理 |
| audit report | 审核报告 |
| Audit Team | 审核组 |
| auditee | 被审核方 |
| Auditee Management | 被审核方管理 |
| auditor | 审核员 |
| BD Executive Leadership Team | BD 执行领导团队 |
| BD Interventional | BD介入 |
| BD Life Sciences | BD生命科学 |
| BD Medical | BD医疗 |
| BD Quality Policy Statement | BD 质量方针声明 |
| Biosciences | 生命科学 |
| business unit | 事业部 |
| CAPA initiation determination | CAPA 启动决定 |
| Central Quality Group | 核心质量组 |
| Central Team | 核心团队 |
| Chief Executive Officer | 首席执行官 |
| Chief Medical Officer | 首席医疗官 |
| Chief Quality Officer | 首席质量官 |
| Chief Regulatory Officer | 首席监管官 |
| Chief Risk Officer | 首席风险管 |
| classification | 分级 |
| closing meeting | 末次会议 |
| complaint handling unit | 投诉处理单元 |
| conclusion | 结论 |
| confidential disclosure agreement | 保密协议 |
| Core Quality Manual | 核心质量手册 |
| Core Quality System | 核心质量体系 |
| Corporate Quality Audit | 公司质量审核 |
| Corporate Regulatory Compliance Head | 公司法规合规负责人 |
| corrective action and preventive action | 纠正和预防措施 |
| corrective action plan | 纠正措施计划 |
| Diabetes Care | 糖尿病护理 |
| Durable Medical Equipment | 耐用医疗设备 |
| effectiveness verification | 有效性验证 |
| entity | 实体 |
| escalation | 上报 |
| establishment inspection report | 出具的审核报告 |
| Executive Vice President | 执行副总裁 |
| External Audit Information Package | 外部审核信息包 |
| External Audit Team | 外部审核团队 |
| failure at install | 安装时故障 |
| field action | 现场行动 |
| Field Action Committee | 现场行动委员会 |
| Finance | 财务 |
| form | 表格 |
| freedom of information | 信息自由 |
| Global Clinical Development | 全球临床研发 |
| Global Executive Leadership Team | 全球执行领导团队 |
| Global Executive Management Team | 全球执行管理团队 |
| global form | 全球表格 |
| Global Management with Executive Responsibility | 担负执行职责的全球管理团队 |
| global policy | 全球政策 |
| global process | 全球流程 |
| Global Process Owner | 全球流程负责人 |
| global quality policy | 全球质量方针 |
| global quality procedure | 全球质量程序 |
| global quality system | 全球质量体系 |
| global technical standard | 全球技术标准 |
| high compliance risk | 高合规风险 |
| Human Resources | 人力资源 |
| Integrated Diagnostic Solutions | 集成诊断解决方案 |
| integrated supply chain | 集成供应链 |
| internal audit | 内部审核 |
| Lead Auditor | 主任审核员 |
| legacy product | 老产品 |
| legal manufacturer | 法定制造商 |
| line manager | 直线经理 |
| local implementation document | 当地实施文档 |
| low compliance risk | 低合规风险 |
| Management Representative | 管理者代表 |
| management review | 管理评审 |
| Management with Executive Responsibility | 担负执行职责的全球管理团队 |
| Manufacturer | 制造商 |
| manufacturing site | 生产工厂 |
| Medical Affairs | 医学事务 |
| medical device report | 医疗器械报告 |
| Medical Safety Office | 医疗安全办公室 |
| Medical Service and Support | 医疗服务与支持 |
| Medication Delivery Solutions | 药品输注解决方案 |
| Medication Management Solutions | 药品管理解决方案 |
| nonconformance | 不合格 |
| nonconformity | 不合格项 |
| objective evidence | 客观证据 |
| Operations | 运营 |
| opportunity for improvement | 改进机会 |
| out-of-box failure | 开箱故障 |
| Peripheral Intervention | 外周介入 |
| Person Responsible for Regulatory Compliance | 法规合规负责人 |
| Pharmaceutical Systems | 制药系统 |
| pre-assessment | 预评估 |
| preventive action plan | 预防措施计划 |
| Principal of Manufacturing | 生产负责人 |
| procedure | 程序 |
| quality agreement | 质量协议 |
| Quality Glossary | 质量术语表 |
| Quality Group | 质量组 |
| Quality Group Lead | 质量组负责人 |
| Quality Group Legal Support | 质量部法律支持 |
| Quality Head | 质量负责人 |
| quality internal audit | 质量内部审核 |
| Quality Lead | 质量负责人 |
| Quality Management System | 质量管理体系 |
| Quality Management System Framework | 质量管理体系框架 |
| Quality Manual | 质量手册 |
| quality metrics | 质量指标 |
| quality objective | 质量目标 |
| quality record | 质量记录 |
| quality scorecard | 质量记分卡 |
| quality system | 质量体系 |
| rating | 分类 |
| recall | 召回 |
| Region | 区域 |
| Regional Group | 区域组 |
| Regulatory Compliance | 法规合规 |
| Research and Development | 研发 |
| root cause | 根本原因 |
| root cause analysis | 根本原因分析 |
| segment | 板块 |
| shared assessment plan | 共享评估计划 |
| site | 场所 |
| Site Leader | 工厂负责人 |
| situational analysis | 情境分析 |
| subject matter expert | 主题专家 |
| supervisor | 主管 |
| supplier | 供应商 |
| Supplier Audit | 供应商审核 |
| supplier management database | 供应商管理数据库 |
| Supplier Quality Representative | 供应商质量代表 |
| Supply Chain | 供应链 |
| Surgery | 外科 |
| top management | 最高管理层 |
| turn-around-time | 周转时间 |
| Urology & Critical Care | 泌尿和重症护理 |
| Vice President Quality & Regulatory Compliance | 质量和法规合规副总裁 |
| virtual audit | 虚拟审核 |
| work instructions | 作业指导书 |
| world-wide | 全球 |
| English | 中文 |
|---|---|
| Pruitt Occlusion Catheter | 封堵球囊导管（Pruitt Occlusion Catheter） |
| Pruitt Irrigation Occlusion Catheter | 外周血管封堵球囊导管（Pruitt Irrigation Occlusion Catheter） |
| Occlusion and Perfusion Catheter Product Family | 封堵与灌注导管产品系列 |
| Distal Perfusion Catheter | 远端灌注导管 |
| Pruitt Aortic Occlusion Catheter | 主动脉封堵导管 |
一、巴德术语表
输液港部分，包括Slim Port ULP Stamped、Adult MRI Port 6fr CHX 和Pport Duo 9.5Fr植入式给药装置（输液港）
| English | 中文 |
|---|---|
| Bending Resistance | 耐弯曲性 |
| Burst Pressure | 爆破压 |
| Leak Test | 连接气体泄漏 |
| Prime Volume | 冲洗体积 |
| Needle Insertion and Withdrawal | 针的穿刺力和拔出力 |
| Gravity Flow Rate | 重力下流量 |
| Puncture Crumb | 穿刺落屑 |
| English | 中文 |
|---|---|
| Adhesive | 粘合剂 |
| Airguard Valved Introducer | 有阀导入器 |
| AV Stent Graft | 血管覆膜支架 |
| Cath. Clip (white) | 导管夹（白色） |
| Catheter | 导管 |
| Catheter Body | 主管导体 |
| Catheter sleeve | 导管小套袖 |
| Cathlock | 导管锁 |
| Conical fitting | 圆锥接头 |
| Cuff | 卡夫套袖 |
| Delivery system | 输送系统 |
| Dilator | 扩张器 |
| Dualator | 扩张器 |
| End Cap | 肝素帽 |
| Extension Leg | 延长管 |
| fixing wing | 固定翼 |
| Flared Stent graft | 血管覆膜支架（喇叭口型） |
| Flushing Hub | 冲洗接头 |
| Grip/handle | 手柄 |
| Guidewire | 导丝 |
| Hypodermic needle | 皮下注射针 |
| ID Lable | ID标签 |
| Introducer needle | 穿刺针 |
| Introducer Safety Needle | 安全穿刺针 |
| Macrointrod ucer (dilator and peel-apart sheath) | 血管鞘（扩张器，撕裂鞘） |
| Medical Transparent Dressing | 医用透明贴膜 |
| Non-coring needle (straight and curved) | 无损伤针（直形、弯形） |
| Port (MRI) | 输液港（MRI） |
| Port (Ti) | 输液港（Ti) |
| Safety clip | 安全夹 |
| Safety clip wings | 安全夹护翼 |
| Safety Scalpel | 刀片 |
| skylite basket | 无尖端式镍钛取石网篮 |
| Strain relief sleeve | 接头颈圈 |
| Stylet (Straight catheter only) | 管芯针（仅直型导管含） |
| Syringe | 冲洗器 |
| Tunneler | 隧道针 |
| vein pick | 血管拉钩 |
| English | 中文 |
|---|---|
| Stem | （输液港）连接杆 |
| AV Stent Graft | 血管覆膜支架 |
| Flared Stent graft | 血管覆膜支架（喇叭口型） |
| English | 中文 |
|---|---|
| WavelinQ™ EndoAVF System | 射频消融导管 |
| Electrosurgical Unit (ESU) | ESU-1射频消融设备 |
| Electrosurgical Pencil | 电外科笔式探头 |
| ESU-1 Electrosurgical Generator | ESU-1电外科发生器 |
| hemostasis valve crosser | 止血阀垫条 |
| introducer sheath | 导入鞘 |
| grounding pads | 接地端 |
| Rotational Indicators | 旋转指示器 |
| Rapid Exchange Tips | 快速交换端 |
| Arterial Catheter | 动脉导管 |
| Venous Catheter | 静脉导管 |
| backstop | 接收器 |
| Catheter Magnet | 导管磁铁 |
| Catheter Handle | 导管手柄 |
| Venous Catheter Shaft | 静脉导管轴 |
巴德Maxzero留置针术语表
| English | 中文 |
|---|---|
| Component | 新部件名称 |
| Bottom housing | 底部外壳 |
| sliding housing | 滑动外壳 |
| handle | 手柄 |
| safety slit | 安全滑块 |
| back cover | 后盖 |
| guidewire pusher | 推送夹 |
| needle cover | 护针帽 |
| needle cover | 针芯 |
| guidewire | 支撑导丝 |
| overmold cath hub | 包塑导管座 |
| catheter hub base | 导管座基座 |
| septum | 隔离塞 |
| septum cap | 隔离帽 |
| septum block | 隔离堵块 |
| needle septum | 针隔离塞 |
| extension tube | 延长管 |
| straight connector | 导管连接座（直型） |
| Y connector | 导管连接座（Y型） |
| connector cap | 端帽 |
| herparin cap | 肝素帽 |
| MaxzeroTM needless connector | MaxzeroTM透明无针接头 |
| Q-syteTM needless connector | Q-syteTM 分隔膜无针密闭式输液接头 |
| clamp | 封管夹 |
| clamp tag | 封管夹标签 |
| English | 中文 |
|---|---|
| Wireform Catheter | 线形合金盘导管 |
二、巴德血液净化装置术语表
| English | 中文 |
|---|---|
| GLIDEPATH™ Long-Term Hemodialysis Catheter | 血液净化中心静脉导管套件（GlidePath™） |
| Product Code (Kit Code) | 产品型号（套件型号） |
| GlidePath™ Straight Catheter, 14.5Fr, 15cm | GlidePath™ 长期血液透析用中心静脉导管，预装支撑导丝 14.5F 标准套件，直型（15cm） |
| GlidePath™ Straight Catheter, 14.5Fr, 50cm | GlidePath™ 长期血液透析用中心静脉导管，预装支撑导丝 14.5F 标准套件，直型（50cm） |
| GlidePath™ Alpha-curve Catheter, 14.5Fr, 19cm | GlidePath™ 长期血液透析用中心静脉导管，14.5F标准套件，弯型（19cm） |
| GlidePath™ Alpha-curve Catheter, 14.5Fr, 31cm | GlidePath™ 长期血液透析用中心静脉导管，14.5F标准套件，弯型（31cm） |
| This code is the shortest straight catheter code in the product family. | 该型号是Glidepath系列产品中，最短的直型导管。 |
| This code is the longest alpha-curve catheter code in the product family. | 该型号是Glidepath系列产品中，最长的预弯导管。 |
| GlidePath® Long-Term Hemodialysis Catheter consist of a Catheter, an End Cap, a Guidewire, a Safety Scalpel, a Tunneler, a Stylet (Straight catheter only), an Airguard Valved Introducer, a Introducer Safety Needle, a Introducer Needle, a Dilator, a Dualator and , Medical Transparent Dressing. 血液净化中心静脉导管套件由导管、肝素帽、导丝、刀片、隧道针、管芯针（仅直型导管含）、有阀导入器、安全穿刺针、穿刺针、扩张器和Dualator 扩张器和医用透明贴膜组成。 |
| Red Arterial Female Luer Connector红色动脉内圆锥鲁尔接头（座） Blue Venous Female Luer Connector蓝色静脉内圆锥鲁尔接头（座） Red Arterial Crimp Collar红色动脉接头颈圈 Blue Venous Crimp Collar蓝色静脉接头颈圈 Extension Legs延长管 Bifurcation固定翼 Cuff卡夫 bonding sleeve tapered锥形固定套管 Catheter Shaft主导管体 Ink墨水 Silicone Sleeve导管小套袖 ID Tag (Priming Volume)ID 标签 （预充容量） Thumb Clamp导管夹EleVation Driver 乳房活检与旋切系统（产品名称） |
| English | 中文 |
|---|---|
| 3DMax MID Anatomical Mesh | 疝修补补片 |
| 3DMax MID Medium Left | 中号中量型疝修补补片，左 |
三、蔡司术语表
| English | 中文 |
|---|---|
| Display
Monitor |
显示器 |
| Invertertube
Invertertubu Inverter tubus |
倒像镜筒 |
| Tube | 镜筒 |
| slit | 裂隙 |
| Camera | 摄像头 |
| Microscope Head | 显微镜体 |
| Milano
Callisto eye Torino IDIS EDIS K TRACK |
不翻译，保持原文 |
| Xenon | 氙灯 |
| Internal data injection | 内置数据投射装置 |
| External data injection | 外置数据投射装置 |
| laterality | 眼别 |
| anterior | 眼前节 |
| posterior | 眼后节 |
| English | 中文 |
|---|---|
| Flat Applicators | 平板施用器 |
| Surface Applicators | 表面施用器 |
| Surgical Drapes, Surgical Drapes sterile | 手术显微镜无菌罩 |
| English | 中文 |
|---|---|
| Display
Monitor |
显示器 |
| Invertertube
Invertertubu Inverter tubus |
倒像镜筒 |
| Tube | 镜筒 |
| slit | 裂隙 |
| Camera | 摄像头 |
| Microscope Head | 显微镜体 |
| Milano
Callisto eye |
不翻译，保持原文 |
| Xenon | 氙灯 |
人工晶状体术语
| English | 中文 |
|---|---|
| Anterior chamber (intraocular) lens | 前房人工晶状体 |
| Body | 主体 |
| Clear optic | 有效光学区 |
| Haptic | 支撑部分 |
| In situ | 模拟眼内状态 |
| In situ | 眼内状态 |
| Intraocular lens (IOL) | 人工晶状体 |
| Loop | 襻（是支撑部分的一部分或支撑本身） |
| Monofocal intraocular lens | 单焦人工晶状体 |
| multifocal intraocular lens | 多焦人工晶状体 |
| Multi-piece intraocular lens | 多件式人工晶状体 |
| One-piece intraocular lens | 单件式人工晶状体 |
| Optic | 光学区 |
| Overall diameter | 总直径 |
| Phakic intraocular lens | 有晶体眼人工晶状体 |
| Positioning hole | 定位孔 |
| Posterior chamber (intraocular) lens | 后房人工晶状体 |
| Dioptric power | 光焦度 |
| Paraxial focal length | 近轴焦距 |
| Reduced focal length | 折合焦距 |
| Optic decentration | 光学偏心 |
| Optic tilt | 光学倾角 |
| Sagitta | 骑跨高度 |
| Vault height | 拱顶高度 |
| Additional wrapping | 附加包装 |
| Custom-made device | 定制装置 |
| Device intended for clinical investigation | 临床调查使用装置 |
| Manufacturer | 制造商 |
| Primary packaging | 原包装 |
| Self-adhesive label | 自粘标签 |
| Storage container | 外包装 |
| Material degradation test | 材料降解性试验 |
| Nd-YAG laser exposure test | Nd-YAG激光照射试验 |
| Non-ocular implantation test | 非眼植入试验 |
| Ocular implantation test | 眼植入试验 |
| Test material | 测试材料 |
| Test of photostability | 光照稳定性试验 |
| Accelerated shelf-life study | 有效期加速试验 |
| Device history record (DHR) | 器械历史记录 |
| Expiration date | 失效日期 |
| Finished intraocular lens lot | 人工晶状体成品批次 |
| Package integrity | 包装完整性 |
| Shelf-life | 有效期 |
| Stability | 稳定性 |
| Sterilization load | 灭菌负荷 |
| Far power | 远焦度 |
| Near power | 近焦度 |
| Cartridge | 导入头 |
| Injection system | 植入系统 |
| Injector | 推注器 |
| Injection channel | 推注通道 |
| Injection course | 推注行程 |
| Preloaded system | 预装式系统 |
| English | 中文 |
|---|---|
| IOL | 人工晶状体 |
| loading chamber | 装载盒 |
| IOL holder | 人工晶状体固定器 |
| injection | 推注 |
| English | 中文 |
|---|---|
| Lens | 晶状体 |
| Toric lens | 环曲面晶状体 |
| Spheric lens | 球面晶状体 |
| Spherical Equivalent (SE) | 等效球镜值 |
另外，以下网址有更多关于光学成像的术语：https://www.zeiss.com.cn/microscopy/service-support/glossary.html#inpagetabs-0
| English | 中文 |
|---|---|
| tubular-access minimally invasive spine surgery (MISS) | 经椎管入路的微创脊柱外科手术（MISS） |
| rebubbling procedure | 再次注气步骤 |
| unmasked | 非盲法 |
| Descemet membrane endothelial keratoplasty (DMEK) | 后弹力层角膜内盘移植术（DMEK） |
| The heads-up 3-D image offers an unprecedented depth of view during internal limiting membrane peeling. | 抬头显示的3D图像能在内界膜剥离术过程中提供了前所未有的景深。 |
| gonioprism lens | 前房角棱镜 |
| gonio structures | 房角结构 |
| two-tailed P value | 双侧检验P值 |
| Clinical Affairs | 临床事务 |
| Ophthalmic Information System | 眼科手术导航工作站 |
| sterilizable caps | 可消毒的盖子 |
| Key components | 核心部件 |
| Characters of Keratoscope | 角膜观察光源 |
| Live video | 动态视频 |
| LRI | LRI（角膜缘松懈切口） |
| “Rhexis” function | “撕囊”功能 |
| preliminary examination | 预先检查 |
| 3D monitor system | 3D显示器系统 |
| 3D visualization | 3D显示 |
| Follow-up | 后续工作 |
| video images | 视频影像 |
| a blue filter | 防蓝光滤光片 |
| alcohol (tested with 2-propanol) | 醇类（用异丙醇测试） |
| aldehyde (tested with glutaraldehyde) | 醛类（用戊二醛测试） |
| quaternary compounds (tested with DDAC) | 四价化合物（用DDAC测试） |
| Monitor Cart | 显示器推车 |
| integrated micro display (Multi Vision (optional)) | 内置微型显示（内投射（选配）） |
| Angled optics | 弯角光楔 |
| Cover, main observer tube | 主镜筒盖 |
| Cover, co-observer tube | 助手镜筒盖 |
| Keratoscope | 角膜镜观察光源 |
| Fractionated vacuum process | 脉动真空法 |
| circularly polarized | 圆偏光 |
| 3D Full HD cameras | 3D 全高清(Full HD)摄像头 |
| UHD cameras | 超高清(UHD)摄像头 |
| Integrated Data Injection System (IDIS) | 镜内投射系统（IDIS） |
| 3D Heads Up Display Systems | 3D平视显示系统 |
| BM | 标准双目显微镜（BM） |
| minimally invasive transforaminal lumbar interbody fusion | 微创经椎间孔入路的腰椎椎间融合术 |
| 统计类术语属于专业术语，是不需要翻译成中文 | |
| Mann–Whitney U test | Mann–Whitney U检验 |
| Wilcoxon signedrank test | Wilcoxon signedrank 检验 |
| Fisher’s exact test | Fisher精确检验 |
| Student’s t-test | Student检验 |
| Pearson’s chi-squared test | Pearson卡方检验 |
| Schlemm’s canal | Schlemm管 |
| English | 中文 |
|---|---|
| vitritis | 玻璃体炎 |
| iritis | 虹膜炎 |
| iridocyclitis | 虹膜睫状体炎 |
| hypopyon | 前房积脓 |
| Cyclitic membrane | 睫状体炎性假膜 |
| ocular infection | 眼部感染 |
| endophthalmitis | 眼内炎 |
| microbial keratitis | 感染性角膜炎 |
| toxic anterior segment syndrome (TASS) | 毒性眼前节综合征 |
| wound leakage | 伤口渗漏 |
| iris prolapse | 虹膜脱出 |
| pupillary block | 瞳孔阻滞 |
| elevated intraocular pressure requiring treatment | 眼内压升高（需治疗） |
| corneal edema | 角膜水肿 |
| corneal endothelial damage | 角膜内皮细胞损伤 |
| retinal detachment | 视网膜脱离 |
| cystoid macular edema | 黄斑囊样水肿 |
| salt precipitation | 盐沉淀 |
| secondary cataract | 继发性白内障 |
| decentration of the lens | 人工晶状体偏心 |
| deviation from target refraction | 偏离目标屈光度 |
| posterior capsule rupture | 晶状体后囊膜破裂 |
| zonular damage | 悬韧带损伤 |
| vitreous loss | 玻璃体脱出 |
| significant anterior chamber bleeding | 严重的前房出血 |
| choroidal hemorrhage | 脉络膜出血 |
| uncontrollable positive intraocular pressure | 无法控制的眼内压升高 |
| glaucoma | 青光眼 |
| aniridia | 无虹膜 |
| microphthalmos or macrophthalmos | 小眼球/大眼球 |
四、MicroVention术语表
| English | 中文 |
|---|---|
| Advertising and Promotional Material | 广告宣传材料管理 |
| Aneurysm | 动脉瘤 |
| Animal Study | 动物试验 |
| BER(Biocompatibility Evaluation Report) | 生物相容性能评估报告 |
| Biocompatibility Evaluation Study | 生物相容性能评价研究 |
| Biological Safety Study | 生物安全研究 |
| Calibration Measurement Uncertainty | 校准不确定度管理 |
| Calibration Program | 校准程序 |
| CER(Clinical Evaluation Report) | 临床评价报告 |
| CF019 Supplier Assessment Survey User Guide | CF019供应商调查问卷使用指南表格 |
| Chemical Property | 化学性能 |
| Coating | 涂层 |
| Coil (As a component) | 线圈 |
| Coil (As a Product) | 弹簧圈 |
| Complaint Data Trending | 质量投诉数据趋势分析 |
| Contract Request Review and Approval | 合同申请评审和批准程序 |
| Contract Review | 合同评审 |
| Contraindications | 禁忌症 |
| Control and Distribution of Finished Goods | 成品出货控制流程 |
| Core Wire | 芯丝 |
| Corrective and Preventive Action （CAPA） | 纠正预防措施 |
| Corrosion | 耐腐蚀性 |
| Degradation | 降解 |
| Design and Development Change Control | 设计和开发文件的变更控制 |
| Design Control | 设计控制 |
| Design Development | 设计开发 |
| Design Review | 设计评审 |
| Design Verification and Validation | 设计验证和确认 |
| Detachment Controller | 分离控制盒 |
| Detachment time | 解脱时间 |
| Dimension | 尺寸 |
| Dimethylacramide-glycidyl methacrylate copolymer | 二甲基丙烯酰胺-缩水甘油基丙烯酸甲酯共聚物 |
| Dispense Coil | 包装盘管 |
| dispenser | 盘管 |
| Distal | 远端 |
| Distal Access Catheter | 远端通路导管 |
| Document Approval Matrix | 文件批准表 |
| Document Change Control | 文件变更控制 |
| Document Control System | 文件控制程序 |
| Document Nomenclature | 文件命名管理 |
| Documents of External Origin | 外来文件管理 |
| E-Beam sterilization | 电子束灭菌 |
| EHS | 环境健康安全 |
| Electronic DraWIHng Procedure | 电子图纸管理 |
| Electronic Records and Electronic Signatures for QMS Software | 质量管理体系软件的电子记录和电子签名 |
| Embolization | 栓塞术 |
| Emergency Response and Fire Protection | 应急响应和消防安全管理 |
| Environmental Control | 环境控制 |
| Equipment Development Qualification and Maintenance | 设备开发、确认于维护保养 |
| Ergonomics Program | 人体工程学管理 |
| ERIC device 和Trevo Device | ERIC 和Trevo |
| ERIC Retrieval Device | ERIC颅内远端取栓系统 |
| Ethics Committee | 伦理委员会 |
| Ethylene Oxide Management Plan | 环氧乙烷管理计划 |
| Ethylene oxide(EO) residue | 环氧乙烷残留 |
| EtO sterilization | 环氧乙烷灭菌 |
| Field Corrective Actions | 现场纠正措施 |
| Filling Coil | 填充弹簧圈 |
| Final Products | 终产品 |
| Finished Goods Inventory Adjustments for Cycle Counts and Lot Realignment Policy and Procedure | 成品库存调整，周期盘点和批次重新调整政策和程序 |
| Finished Product Inspection | 成品检验 |
| Finishing coil | 收尾弹簧圈 |
| First Article Inspection | 首件确认 |
| Flexibility | 灵活性，柔顺性 |
| Flexibility (a test item) | 弯曲性能 |
| Framing coil | 成篮弹簧圈 |
| Framing performance | 成篮性能 |
| General Training Requirements | 通用培训要求 |
| Good Documentation Practices | 良好的书写规范 |
| Guide Catheter | 导引导管 |
| Guide Wire | 导丝 |
| Handling, Storage, Packing, Preservation and Delivery | 物料搬运、贮存、包装、防护和交货程序 |
| Hazard Communication Program | 危害信息交流沟通流程 |
| Hazardous Waste Control | 危害废弃物控制流程 |
| HDPE | 高密度聚乙烯 |
| Hub | 座 |
| Hydrophilic Coating | 亲水涂层 |
| ID | 内径 |
| IFU | 使用说明书 |
| IFU Generation and Revision Procedure | 说明书编制和修订程序 |
| In-Process Inspection | 过程检验 |
| Insert Tool | 插入工具 |
| Inspection by a Regulatory Agency | 法规监管机构检查 |
| Institutional Review Board (IRB) | 研究审查委员会 |
| Intended Use | 适应症 |
| Internal Assessment Process | 内审程序 |
| Interventional | 神经介入 |
| Intracranial | 颅内 |
| Invention Documentation Procedure and Submission for Patent Application | 发明记录程序及专利申请的提交 |
| IQ(Install Qualifcation)/OQ(Operate Qualfication) | 安装确认/操作确认 |
| IT Applications Software Development Life Cycle | IT应用软件开发生命周期 |
| IT Data Backup and Restore Policy | IT 数据备份和恢复政策 |
| IT Support Request | IT支持申请 |
| Label Creation and Revision Procedure | 标签的创建和修订程序 |
| Labeling Requirements | 标签要求 |
| Limits for acidity or alkalinity(PH) | 酸碱度 |
| Lockout Tagout Program | 挂牌上锁程序 |
| Maintenance System | 维护系统 |
| Management Responsibility | 管理职责 |
| Mandrel | 塑形杆 |
| Manufacture Information | 生产信息 |
| Mechanical Property | 机械性能 |
| Metal ions | 金属离子 |
| Microbial Monitoring in CEA | 洁净区微生物监测 |
| Microcatheter Catheter | 微导管 |
| MicroVention Costa Rica | 美科微先哥斯达黎加 |
| MicroVention Europe | 美科微先欧洲有限公司 |
| MicroVention Hangzhou | 美科微仙杭州有限公司 |
| MicroVention Inc. | 美科微先公司 |
| MicroVention IT – Associate Status Procedure | 员工IT权限管理程序 |
| MP2 Computer Maintenance Management System | MP2 预防性维护管理系统 |
| NCR Guidance | 不合格报告填写指南 |
| Neurovasculature | 神经血管 |
| Nitinol | 镍钛合金 |
| Nitinol Wire | 镍钛诺丝 |
| Normality and Gage R&R Assessment | 正态性检验和量具重复性和再现性评估 |
| Occlusion | 闭塞 |
| OD | 外径 |
| Packaging Material | 包装材料 |
| Particulate Monitoring in CEA | 洁净区微粒监测 |
| Particulate testing | 微粒控制试验 |
| Patient Risk Evaluation | 患者风险评估 |
| Personal Protective Equipment | 个人防护设备 |
| Pest Control | 害虫控制 |
| Pivotal Study of The MicroVention Flow Re-Direction Endoluminal Device System In The Treatment Of Intracranial Aneurysms | MicroVention FRED血流导向装置用于颅内动脉瘤治疗的关键研究 |
| Platinum/Nickel | 铂/镍合金 |
| Polycarbonate | 聚碳酸酯 |
| Polypropylene | 聚丙烯 |
| POQ | 工艺过程操作鉴定 |
| Post Market Clinical Follow-up (PMCF) Plan and Report | 上市后临床随访(PMCF)计划和报告 |
| Post Market Surveillance Report | 上市后监管报告 |
| Post-Marketing Evaluations | 上市后监管 |
| PPQ | 工艺过程性能鉴定 |
| Primary Sterile Barrier | 初级无菌屏障 |
| Process Flow Chart | 生产过程流程图 |
| Process Operational Qualfication | 生产过程操作确认 |
| Process Validation | 生产过程验证 |
| Process Validation | 过程验证 |
| Product Carton Box | 产品包装盒 |
| Product Complaint Handling | 产品质量投诉处理流程 |
| Product Identification and Traceability | 产品标识和追溯性管理 |
| Product Investigations | 产品调查 |
| Product Performance Qualification | 产品性能确认 |
| Product Returns | 产品退货程序 |
| Proximal | 近端 |
| PTFE（Polytetrafluoroethylene） | 聚四氟乙烯 |
| PTR（Product Technical Requirement ） | 技术要求 |
| Purchasing | 采购管理 |
| Pusher | 递送推杆 |
| Pusher resistant | 递送推杆电阻 |
| Pyrogen | 热原 |
| QMS Software Development Life Cycle | 质量管理体系软件开发生命周期 |
| QMS Software Project / Change Request | 质量管理体系软件项目/变更请求 |
| QMS Software Requirements Risk Assessment | 质量管理体系软件要求的风险评估 |
| QMS Software Testing Guidelines | 质量管理体系软件测试指南 |
| Quality Management System | 质量管理体系 |
| Quality Planning | 质量计划 |
| Quality Records | 质量记录 |
| Quality Reporting | 质量报告 |
| Quality System Corrective and Preventive Action Process | 质量体系纠正预防措施 |
| Quality System Training | 质量体系培训程序 |
| Radiopacity | 射线不透性 |
| Raw Material | 原材料 |
| Receiving Inspection | 来料检验 |
| Repated release fatigue | 反复释放疲劳试验 |
| Research Information | 研究资料 |
| Resistance to bending | 弯曲性能 |
| Resistance to corrosion properties | 耐腐蚀性 |
| Resistance to rupture | 破裂性能 |
| Resource Management | 资源管理 |
| Returned Product Decontamination | 退货产品去污流程 |
| Review of Nonconforming Materials | 不合格品评审 |
| Risk Management | 风险管理 |
| Risk Management for Software | 软件风险管理 |
| Saccular | 囊状 |
| Schematic Drawing | 结构示意图 |
| Shaping Mandrel | 塑形杆 |
| Sheath | 鞘套, 护套 |
| Shelf life | 货架有效期 |
| Simulated Use | 模拟使用 |
| Software Controls | 软件控制 |
| Software Controls of Automated Process Equipment | 自动化设备的软件控制 |
| Software Controls of Non-Equipment Production software | 生产用非设备软件控制 |
| Software Validation | 软件验证 |
| Spreadsheet Control | 电子表格控制 |
| Spring constant | 弹簧常数 |
| Stainless Steel (SS) | 不锈钢 |
| Statistical Methods | 统计方法 |
| Statistical Process Control | 统计过程控制 |
| Stent | 支架 |
| Stent-Assisted Coiling | 支架辅助弹簧圈 |
| Sterility | 无菌 |
| Sterilization | 消毒灭菌 |
| Sterilization /Disinfection Methods | 消毒灭菌方式 |
| Sterilization Process Control | 灭菌过程控制 |
| Stretch resistant tensile | 抗解旋性能 |
| Subassembly | 组建 |
| Summary | 综述资料 |
| Supplier Audit Process | 供应商审核程序 |
| Supplier Control Process | 供应商控制程序 |
| Supplier Corrective Action Request (SCAR) Process | 供应商纠正措施 (SCAR) 程序 |
| Tensile Strength | 抗拉强度，拉伸强度 |
| Tensile Test | 拉力试验 |
| Terumo | 泰尔茂公司 |
| Test Protocols, Test Reports and Test Methods | 测试方案、测试报告和测试方法 |
| Testing report | 检测报告 |
| Tip Shaping | 尖端塑形 |
| Torque Device | 扭矩装置 |
| Training Production Assemblers | 生产操作员培训程序 |
| Training Quality Control Inspectors | 质量检验员培训程序 |
| Transfer Project Management Procedure | 项目转移管理程序 |
| Trevo Pro Retriever | Trevo支架 |
| Type Test | 型式试验 |
| Tyvek/Polyethylene/Polyester | 特卫强/聚乙烯/聚酯纤维（涤纶） |
| Ultraviolet absorbance | 紫外吸光度 |
| Validation | 验证 |
| Verfication | 确认 |
| Vigilance Incident Reporting | EU MEDDEV Vigilance系统不良 事件上报管理 |
| Visual Appearance | 外观 |
| WEB-IT Study | WEB腔内疗法研究 |
| Whitebox Testing Process | 白盒测试程序 |
| Wide Neck Bifurcation Aneurysm (WNBA) | 颅内分叉部宽颈动脉瘤 |
| Work Orders | 工单管理 |
| English | 中文 |
|---|---|
| EPD Delivery and Retrieval Catheter Visual Inspection | EPD 输送和回收导管外观检查 |
| EPD and Catheters Dimensional lnspection | EPD 和导管尺寸检查 |
| EPD Deployment and Retrieval Forces | EPD 布放力和回撤力 |
| Delivery and Retrieval Catheter Destructive Tensile Test | 输送和回收导管破坏性拉力试验 |
| EPD Destructive Tensile Test | EPD 破坏性拉力试验 |
| EPD Pore Measurement | EPD 孔径测量 |
| EPD Buckle Test | EPD 屈曲试验 |
| EPD Tracking/kink Resistance Test | EPD 追踪/抗扭结性试验 |
| EPD Particulate Capture Test | EPD 颗粒捕获试验 |
| Delivery and Retrieval Catheter Destructive Torque Test | 输送和回收导管破坏性扭矩试验 |
| EPD Guidewire Coating Adherence Testing | EPD 导丝涂层附着力试验 |
| Radial Force Testing | 径向力试验 |
| EPD Capacity | EPD 能力 |
| EPD System Guidewire Compatibility | EPD 系统导丝兼容性 |
| Delivery Dispenser Coil | 递送包装盘管 |
| Retrieval Catheter Subassembly | 回收导管装配 |
| EPD | 栓塞保护器 |
| English | 中文 |
|---|---|
| Force at break | 峰值拉力 |
| Occlusion catheter | 封堵球囊导管 |
| HydroSoft 3D | 三维膨胀弹簧圈 |
血管支架术语
| English | 中文 |
|---|---|
| Balloon-assisted deployment | 球囊辅助释放装置 |
| balloon winging | 球囊翼效应 |
| delivery system | 输送系统 |
| Determine | 测定 |
| Evaluate | 评价 |
| Dogboning | 狗骨头效应 |
| Coating | 涂层 |
| drug content | 载药量 |
| lumen reduction | 管腔狭窄 |
| reportable clinical events | 应报告临床事件 |
| stent configuration | 支架构型 |
| stent outer surface area | 支架外表面积 |
| stent-free surface area | 支架空白表面积 |
| stent system | 支架系统 |
| vascular stent | 血管支架 |
| Implant | 植入物 |
| articulated stent | 铰接支架 |
| bare stent | 裸支架 |
| bioabsorbable stent | 生物可吸收支架 |
| balloon-expandable stent | 球囊扩张支架 |
| coated stent | 涂层支架 |
| composite stent | 复合支架 |
| covered stent | 覆膜支架 |
| drug-eluting stent (DES) | 药物洗脱支架 |
| self-expanding stent | 自扩张支架 |
| Acute coating integrity | 短期涂层完整性 |
| Stent integrity | 支架完整性 |
| Biocompatibility | 生物相容性 |
| Haemostasis | 止血性 |
| Balloon deflation time | 球囊卸压时间 |
| Balloon inflation time | 球囊充压时间 |
| Ability to deploy | 释放性能 |
| Balloon rated burst pressure (RBP) | 球囊额定爆破压 |
| Balloon rated fatigue | 球囊额定疲劳 |
| Bond strength | 结合强度 |
| Ability to access | 通过性能 |
| Ability to withdraw | 回撤性能 |
| Coating dimensions | 涂层尺寸 |
| Coating durability | 涂层耐久性 |
| Coating particulate generation | 涂层颗粒形成 |
| Component dimension compatibility | 组件尺寸兼容性 |
| Conformability to vessel wall | 贴壁性 |
| Fixation effectiveness | 固定有效性 |
| Corrosion | 耐腐蚀性 |
| Crush resistance with parallel plates | 抗平行挤压性能 |
| Patency | 畅通性 |
| Crush resistance with radially applied load | 径向抗挤压性能 |
| Dimensional verification | 尺寸验证 |
| Sizing | 尺寸 |
| Dislodgment force | 移除力 |
| Drug content/amount | 载药量 |
| Drug identity | 药物定性 |
| Elution profile | 洗脱曲线 |
| Fatigue durability testing | 疲劳耐久测试 |
| Flex/kink | 弯曲/打折 |
| Force to deploy | 释放力 |
| Local compression | 局部抗挤压 |
| MRI safety and compatibility | MRI安全性和兼容性 |
| Profile/diameter | 轮廓/直径 |
| Profile effect/flaring | 轮廓效应/喇叭口 |
| Ability to accurately deploy | 准确释放性能 |
| Pushability | 推送性 |
| Radial force | 径向支撑力 |
| Recoil | 回缩 |
| Simulated use | 模拟使用 |
| Stent diameter to balloon inflation pressure | 支架直径与球囊充盈压力 |
| Stent-free surface area and stent outer surface area | 支架空白表面积和支架外表面积 |
| Stent length to diameter relationship | 支架长度与直径的关系 |
| Stress/strain analyses (e.g. finite element analysis) | 应力/应变分析（如有限元分析） |
| Torquability | 扭转性 |
| Torsional bond strength | 扭转结合强度 |
| Trackability | 跟踪性 |
| Tubing tensile strength | 管材拉伸强度 |
| Visibility | 可视性 |
| Visual inspection | 外观检验 |
| Access failure | 未能达到预期位置 |
| Accessory device failure | 辅件器械失效 |
| Adverse biological response (toxicity) to stent coating or drug elution (if applicable) | 支架涂层或药物洗脱（如适用）引起的不良生物反应（毒性） |
| Aneurysm | 动脉瘤 |
| Angina | 心绞痛 |
| Arrhythmia | 心律失常 |
| Atelectasis/pneumonia | 肺不张/肺炎 |
| Branch vessel occlusion | 分支血管堵塞 |
| Coagulopathy | 凝血障碍 |
| Congestive heart failure | 充血性心力衰竭 |
| Damage to stent | 支架损坏 |
| Deep vein thrombosis | 深静脉血栓 |
| Deployment failure (delivery system failure) | 释放失效（输送系统失效） |
| Embolization | 栓塞 |
| Haematoma | 血肿 |
| Hepatic encephalopathy | 肝性脑病 |
| Hypotension | 低血压 |
| Impotence, vasculogenic | 血管性阳痿 |
| In-segment restenosis | 节段中再狭窄 |
| Insertion site infection, deep | 插入部位感染，深度 |
| Insertion site infection, superficial | 插入部位感染，表破 |
| In-stent restenosis | 支架内再狭窄 |
| Ischemia | 局部缺血 |
| Late mortality | 晚期死亡率 |
| Lymphocele/lymphatic fistula | 淋巴囊肿/淋巴瘘 |
| Malaposition of stent | 支架贴壁不良 |
| Myocardial infarction | 心肌梗死 |
| Neurological deficit | 神经功能障碍 |
| Periprocedural mortality | 与手术相关的死亡率 |
| Post-procedure bleeding | 术后出血 |
| Procedural bleeding | 术中出血 |
| Pulmonary embolism | 肺栓塞 |
| Recurrence of portal hypertension | 门静脉高压复发 |
| Renal insufficiency | 肾功能衰竭 |
| Residual stenosis | 残余狭窄 |
| Respiratory failure | 呼吸衰竭 |
| Restenosis | 再狭窄 |
| Spinal neurological deficit | 脊髓神经功能障碍 |
| Stent fracture | 支架断裂 |
| Stent infection | 支架感染 |
| Stent migration | 支架移位 |
| Stent thrombosis | 支架血栓 |
| Trauma to adjacent structures | 邻近结构损伤 |
| Vascular trauma | 血管损伤 |
| Vessel occlusion, intraprocedural | 术中血管闭塞 |
| Vessel occlusion, late | 血管闭塞，后期 |
| Vessel occlusion, periprocedural | 血管闭塞，与手术相关 |
| English | 中文 |
|---|---|
| low-profile stent | 超精细支架 |
五、BD一次性给药装置留置针术语表
| English | 中文 |
|---|---|
| winged infusion set | 一次性使用植入式给药装置留置针 |
| Small Medi Clamp | 拇指夹 |
| Tubing | 延长管 |
| Wings | 针翼翻板 |
| Needle | 输液针 |
| Needle Protector | 输液针保护套 |
| Female Luer Lock Adaptor | 鲁尔接头 |
| Male Luer Lock Cap | 鲁尔接头盖 |
| Needleless | 无针接头 |
| non-coring needle | 无损伤针 |
| Insertion Force | 穿刺力 |
| Resistance to breakage | 韧性 |
| Stiffness | 刚度 |
| Gauging | 计量 |
| Unscrewing torque | 卸针扭矩 |
| Ease of assembly | 易装配性 |
| Resistance of overriding | 抗过载性（抗滑丝性） |
| Stress cracking | 应力开裂 |
六、BD微生物和临床试验术语表
| English | 中文 |
|---|---|
| Affirm VPIII Microbial Identification Test | 阴道炎微生物检测试剂盒 |
| Affirm VPIII Ambient Temperature Transport System | 阴道炎检测恒温运输系统 |
| Affirm VPIII Sample Collection Set | 阴道样本采集器 |
| BD MicroProbeTM Processor | 微探针自动处理仪 |
| swab | 采样拭子 |
| Candida | 念珠菌 |
| Gardnerella vaginalis | 阴道加德纳菌 |
| Trichomonas vaginalis | 阴道毛滴虫 |
| Detection, identification | 检测 |
| DNA Probe Test | DNA探针检测 |
| Predicate device | 对比试剂 |
| Culture | 培养 |
| Microscopy | 显微镜检查 |
| Sabouraud’s Dextrose Agar with Chloramphenicol | 带有氯霉素的沙氏葡萄糖琼脂 |
| Wet mount | 湿涂片 |
| Gram stain | 革兰氏染色法 |
| Slide Latex Agglutination Test | 载玻片乳胶凝集试验 |
| Nucleic acid hybridization test | 核酸杂交检测 |
| Multi-well reagent cassette | 多孔试剂板 |
| Color-development probe | 显色探针 |
| Capture probe | 捕获探针 |
| Target organism | 目标微生物 |
| Lysis solution | 裂解液/溶血素 |
| Affirm Sample Processor | Affirm样本处理器 |
| Enzyme conjugate | 酶标记物 |
| Caputre | 捕获 |
| Bind | 结合 |
| Bead | 微球 |
| blue-colored product | 蓝色产物 |
| Enzyme substrate | 酶底物（酶基质） |
| Probe | 探针 |
| Wash away | 洗除 |
| Conjugate | 标记物 |
| Sodium azide | 叠氮化钠 |
| Preservative | 保存剂 |
| Negative control | 阴性对照 |
| Positive control | 阳性对照 |
| Patient sample reservoir | 患者样本储液槽 |
| Hybridization solution | 杂交液 |
| Formamide | 甲酰胺 |
| Buffered chaotropic solution | 缓冲离液 |
| Wash solution | 洗液 |
| Detergent | 洗涤液 |
| Buffer solution | 缓冲液 |
| Substrate solution | 底物溶液 |
| Indicator substrate | 指示剂底物 |
| Stabilizing agent | 稳定剂 |
| Timer | 计时器 |
| Thermometer | 温度计 |
| Foil pouch | 铝箔袋 |
| Dropper tube | 试剂点滴管 |
| Filter tip | 过滤吸头 |
| Package insert | 说明书 |
| Guidelines for Registration Technical Review on Nucleic Acid Amplification Test Reagents | 核酸扩增法检测试剂注册技术审查指导原则 |
| Guidelines | 指导原则 |
| main raw materials | 主要原材料 |
| process techniques | 生产工艺 |
| reaction system | 反应体系 |
| applicant | 申请人 |
| rationales | 理由 |
| regulatory reviewer | 审查人员 |
| administrative affairs | 行政事项 |
| regulations | 法规 |
| study data | 研究资料 |
| verification data | 验证资料 |
| registration-purpose technical review | 注册技术审查 |
| manufacturer | 生产企业 |
| Medical Device Manufacturing License | 医疗器械生产许可证 |
| auxiliary materials | 辅料 |
| quality standards | 质量标准 |
| nucleic acid extraction | 核酸提取 |
| amplification | 扩增 |
| contamination | 污染 |
| nucleic acid-based detection of bacterial pathogens | 病原微生物核酸检测 |
| biosafety | 生物安全 |
| Implementing Rules for Production of In-vitro Diagnostic Reagents (Trial) | 体外诊断试剂生产实施细则（试行） |
| Evaluation Criteria for the Quality Management System of Manufacturers of In-vitro Diagnostic Reagents (Trial) | 体外诊断试剂生产企业质量管理体系考核评定标准（试行） |
| primer | 引物 |
| inner-marker | 内标 |
| outer-marker | 外标 |
| analytical pure (A.P.) | 分析纯 |
| probe | 探针 |
| manufacturer’s reference product | 企业参考品 |
| standard product | 标准品 |
| preparation process | 制备过程 |
| factory inspection report | 出厂检定报告 |
| free from DNase and RNase contamination | 无脱氧核糖核酸酶（DNase）和核糖核酸酶（RNase）污染 |
| deoxynucleotide triphosphate (dNTP) | 脱氧三磷酸核苷（dNTP） |
| Components of nucleic acid | 核酸的组成成分 |
| high performance liquid chromatography (HPLC)-pure | 高效液相色谱（HPLC）纯 |
| Specific sequence composed of certain dNTP | 由一定数量的dNTP构成的特定序列 |
| in general artificially synthesized with DNA synthesizer | 通常采用脱氧核糖核酸（DNA）合成仪人工合成 |
| After synthesizing, the primer is purified with polyacrylamide gel electrophoresis (PAGE) or by other appropriate methods. | 合成后经聚丙烯酰胺凝胶电泳（PAGE）或其他适宜方法纯化 |
| freeze-dry powder | 冻干粉 |
| with correct sequencing | 序列正确 |
| PAGE-level | 电泳级（PAGE） |
| HPLC-level | HPLC级 |
| impurity band | 杂带 |
| the quality inspection evidence issued by the agency of synthetization shall be provided. | 应提供合成机构出具的合成产物的质检证明 |
| PAGE results and HPLC chromatogram | PAGE电泳结果或高效液相色谱法（HPLC）分析图谱 |
| UV absorption analysis | 紫外光吸收分析 |
| UV spectrophotometer | 紫外分光光度计 |
| qualified primer | 合格引物 |
| Known nucleic acid fragment (oligonucleotide fragment) with specific tracer (marker), can be hybridized in annealing with the complementary nucleic acid, and is used for detection of specific nucleic sequence | 是指特定的带有示踪物（标记物）的已知核酸片段（寡聚核苷酸片段），能与互补核酸序列退火杂交，用于特定核酸序列的探测 |
| marked at 5′-end (and/or 3′-end) | 在5′-端(和/或3′-端)进行标记 |
| fluorescent reporter group | 荧光素报告基团 |
| luminescent marker | 发光标记物 |
| fluorescent quenching group marked at 3′-end | 在3′-端标记荧光素淬灭基团 |
| nucleic acid sequence | 核酸序列 |
| marked fluorescence | 标记的荧光素 |
| chemiluminescent | 化学发光物 |
| absorption peak | 吸收峰 |
| In addition, there should be absorption peak at the excitation wavelength of fluorescence depending on the specific property of marked fluorescence. | 另外，根据标记荧光素的不同，还应该在荧光素的激发波长处有吸收峰 |
| specific absorption peak | 特异的吸收峰 |
| hybridization probe | 杂交探针 |
| DNA polymerase | DNA聚合酶 |
| DNA polymerase shall have the vitality of DNA polymerase but not that of endonucleautomotive service engineers | 具有DNA聚合酶活性，无核酸内切酶活性 |
| thermal-stability | 热稳定性 |
| Uracil-DNA Glycosylase (UNG) | 尿嘧啶糖基化酶（UNG） |
| have no vitality of exonucleautomotive service engineers and endonucleautomotive service engineers | 无核酸外切酶及核酸内切酶活性 |
| All U-contained templates under 10^3 duplicates shall be fully degraded | 10^3拷贝以下含U模板应完全降解 |
| No amplification products shall be generated | 不能产生扩增产物 |
| reverse transcriptase | 逆转录酶 |
| shall have the vitality of reverse transcriptase | 具逆转录酶活性 |
| preparation of working fluid | 配制工作液 |
| verification of half-finished product | 半成品检定 |
| sub-packing and packing | 分装和包装 |
| proportions | 配比 |
| conductivity rate | 电导率 |
| critical parameters | 关键参数 |
| specimen | 样本 |
| calibration method | 校准方法 |
| quality control method | 质控方法 |
| critical value | 临界值 |
| stability | 稳定性 |
| shelf life | 有效期 |
| lot number | 批号 |
| reference/control product | 参考品/对照品 |
| national standard or reference product | 国家标准品或参考品 |
| manufacturer’s reference product | 企业参考品 |
| State Food and Drug Administration (SFDA) | 国家食品药品监督管理局 |
| negative/positive reference conformity rate | 阴/阳性参考品符合率 |
| sensitivity | 灵敏度 |
| specificity | 特异性 |
| precision | 精密度 |
| kits | 试剂盒 |
| amount of trial production | 试生产量 |
| verification of analytical performance | 分析性能验证 |
| clinical trial | 临床试验 |
| self-testing and registration testing | 自测及注册检验 |
| sampling | 抽样 |
| linearity range (quantitative products) | 线性范围（定量产品） |
| Nucleic Acid Amplification Test Reagents: The Nucleic Acid Amplification Technique generally refers to the techniques used to detect specific nucleic acid sequence or screen specific genes based on amplified DNA or RNA, including PCR, LCR or TMA, etc. | 核酸扩增法检测试剂：核酸扩增技术泛指以扩增脱氧核糖核酸（DNA）或核糖核酸（RNA）为手段，检测特定核酸序列或筛查特定基因的检测技术，如聚合酶链反应（PCR）、连接酶链反应（LCR）、转录依赖的扩增反应（TMA）等。 |
| In-vitro Diagnostic Reagents | 体外诊断试剂 |
| pathogen detection | 病原体检测 |
| early-stage diagnosis of specific diseases | 特定疾病的早期诊断 |
| type identification of substance in vivo | 体内物质的型别鉴定 |
| Basic Requirements for the Registration Application Data of Immunohistochemical Reagents and Test Kits | 免疫组织化学抗体试剂及检测试剂盒注册申报资料的基本要求 |
| The Immunohistochemical Reagents and Test Kits refer to the test reagents using the chemical technique of immunology theory in combination of enzyme substrate-based color development, to detects the antigens in tissue specimens. | 免疫组织化学抗体试剂及检测试剂是指一类利用免疫学原理结合酶催化底物显色的化学方法，检测组织标本中抗原的检测试剂。 |
| This kind of reagents are test packages containing target antigen-specific monoclonal or multi-clonal antibodies, or containing antibodies, color development system, control reagent, calibrator, and other auxilliary reagents, packed in kit form. | 此类试剂为待测抗原特异性单克隆或多克隆抗体，或抗体与显色系统、对照试剂、质控片及其它辅助试剂一同包装成试剂盒形式的检测试剂盒 |
| color development system | 显色系统 |
| control reagent | 对照试剂 |
| calibrator | 质控片 |
| auxilliary reagent | 辅助试剂 |
| multi-stage detection | 多步骤检测 |
| cell-specific antigen | 细胞的特异性抗原 |
| cell phenotype | 细胞的表型 |
| identification diagnosis | 鉴别诊断 |
| prognosis evaluation | 预后判断 |
| administration guide | 指导用药 |
| Class III IVD Reagent | 三类体外诊断试剂 |
| registration application | 注册申报 |
| Administrative Measures on In-vitro Diagnostic Reagent Registration (Trial) | 体外诊断试剂注册管理办法（试行） |
| Guidelines on Techniques Involved in Clinical Investigation of IVD Reagents | 体外诊断试剂临床研究技术指导原则 |
| Cuidelines on Compilation of Instructions for Use of IVD Reagent | 体外诊断试剂说明书编写指导原则 |
| pathological test | 病理检测 |
| technical review | 技术审评 |
| reviewer | 审评人员 |
| adjust from time to time | 适时调整 |
| applicant | 申请人 |
| detailed rationales | 详细说明 |
| performance verification data | 性能验证资料 |
| different IHC markers | 免疫组化不同标志物 |
| markers whose use is associated with various indexes | 临床使用多个指标综合诊治的标志物 |
| disease monitoring | 病情监测 |
| instructions for use (IFU) | 产品说明书 |
| primary antibody reagent | 第一抗体试剂 |
| secondary antibody reagent | 第二抗体试剂 |
| generic name | 通用名称 |
| target antigen-specific antibodies | 待测抗原特异性抗体 |
| immunohistochemistry (IHC) | 免疫组织化学法 |
| estrogen receptor antibody reagent | 雌激素受体抗体试剂 |
| progesterone receptor antibody kit | 孕酮受体检测试剂盒 |
| specimen | 样本 |
| frozen and paraffin-embedded specimen | 冰冻和/或石蜡包埋样本 |
| clone no. | 克隆号 |
| positive staining | 阳性着色 |
| Interpretation to any positive or negative results shall be made by pathologist in combination of morphology, clinical signs and other detection methods, and shall never be used as diagnosis basis independently. | 对任何阳性或阴性结果的解读，应由病理医生结合病理形态学、临床表现及其它检测方法进行，不作为单独的诊断指标 |
| sample acquisition, fixing, embedding and stability | 取材、固定、包埋及稳定性 |
| decalcification treatment | 脱钙处理 |
| pre-staining processing steps | 染色前处理步骤 |
| antigen retrieval means | 抗原修复方式 |
| concentrated antibody | 浓缩型抗体 |
| working solution | 抗体工作液 |
| diluent | 稀释液 |
| interpretation of test results | 检测结果的解释 |
| positive staining characteristics | 阳性着色特点 |
| staining locations | 着色部位 |
| reference value (reference range) | 参考值（参考范围） |
| testing | 检验 |
| detection | 检测 |
| study data | 研究资料 |
| immunogen data | 免疫源资料 |
| epitope identification of antibody | 抗体识别表位 |
| affinity | 亲和力 |
| titer | 效价 |
| double agar diffusion method | 双向琼脂扩散法 |
| internal calibrator | 内部质控片 |
| accompanying kit calibrator | 试剂盒配套质控片 |
| confining liquid | 封闭液 |
| endogenous enzyme activity | 内源性酶活性 |
| endogenous biotin | 内源性生物素 |
| staining temperature | 染色温度 |
| immunoreaction | 免疫反应性 |
| precision | 精密度 |
| testing time (within-day, between-days） | 检测时间（日内/日间） |
| applied machine | 适用机型 |
| semi-quantitative | 半定量 |
| supporting references | 文献支持资料 |
| to prove the relations among markers, efficacy, and viability | 论证标记物与疗效、生存率之间的关系 |
| lab/multi-center clinical study data | 实验室/多中心临床试验资料 |
| stability study data | 稳定性研究资料 |
| unpacked/diluted | 开瓶/稀释 |
| shelf stability | 货架稳定性 |
| onboard stability | 机载稳定性 |
| clinical trial data | 临床试验资料 |
| clinical trial institutions | 临床试验机构 |
| sample collection | 样本选取 |
| clinical indications | 临床适应症 |
| normal tumor-adjacent control | 癌旁正常对照 |
| benign and malignant diseases | 良、恶性疾病 |
| tissue microarray | 组织芯片 |
| international authority bodies | 国际权威机构 |
| raw data | 原始数据 |
| positive conformity rate | 阳性符合率 |
| negative conformity rate | 阴性符合率 |
| confidence interval | 置信区间 |
| statistical check | 统计检验 |
| classification statistics | 分级统计 |
| between-lab staff variance | 实验人员间差异 |
| between-lab variance | 实验室间差异 |
| staining slide | 染色片 |
| ready-to-use type | 即用型 |
| manual type | 手工操作 |
| onboard type | 上机操作 |
| BD CD10 Kit (flow cytometry – FITC) | 白细胞分化抗原CD10检测试剂（流式细胞仪法-FITC） |
| BD CD34 Kit (flow cytometry – PE) | 白细胞分化抗原CD34检测试剂（流式细胞仪法-PE） |
| BD CD19 Kit (flow cytometry – APC) | 白细胞分化抗原CD19检测试剂（流式细胞仪法-APC） |
| BD CD45 Kit (flow cytometry – PerCP) | 白细胞分化抗原CD45检测试剂（流式细胞仪法-PerCP） |
| BD CD7 Kit (flow cytometry – FITC) | 白细胞分化抗原CD7检测试剂（流式细胞仪法-FITC） |
| BD CD117 Kit (flow cytometry – PE) | 白细胞分化抗原CD117检测试剂（流式细胞仪法-PE） |
| BD CD33 Kit (flow cytometry – APC) | 白细胞分化抗原CD33检测试剂（流式细胞仪法-APC） |
| Clinical Trial Permission | SFDA批件 |
| CRF Transmission Form | CRF收集运送表 |
| CSR Review Form | CSR审核表 |
| SAE Submission Letter to Sponsor/EC /SFDA/PFDA | SAE递交信 |
| SAE General Tracking Form (PL) | SAE汇总跟踪记录表（PL） |
| Filing Receipt from SFDA/PFDA | SFDA/省局备案 |
| SOP Waiver Request Form | SOP豁免申请表 |
| SUSAR Submission Letter to EC | SUSAR递交信 |
| SUSAR General Tracking Form (PL) | SUSAR汇总跟踪表（PL） |
| Safety Plan | 安全计划 |
| Insurance Statement | 保险责任声明 |
| Blank Case Report Form & Updates (Sample) | 病例报告表及更新件（样本） |
| Financial Disclosure Form & Updates | 财务状况声明及新增件 |
| Shipping Records for Products Supply from CRO/Sponsor to Site | 从CRO或申办方到研究中心试剂运送记录 |
| Shipping Records for Products Supply from Sponsor to CRO | 从申办方到CRO试剂运送记录 |
| IVD Ordering Form | 订试剂表 |
| Reference Product Package Insert | 对比试剂说明书 |
| IVD Dispensing Log | 发试剂记录表 |
| Protocol Approval Form/Protocol Approval Form for Revision | 方案批准表/试验方案/及修正版和更新后批准表 |
| Protocol Signature Page & Updates | 方案认可签署页及更新件 |
| Protocol Violation Form/Violation Log | 方案违反表/方案违反登记记录 |
| Protocol Violation Tracker | 方案违反追踪记录表 |
| Clinical Trial Expense Application and Record | 付款申请及记录 |
| Communication and Escalation Plan | 沟通和问题上报计划 |
| Audit Certificate (if applicable) | 稽查证明（如果适用） |
| Monitoring Plan & Updates | 监查计划及更新 |
| Confirmation Letter/ Monitoring Report/Follow-up Letter | 监查确认函/监查报告/监查跟进函 |
| Handover Checklist between CRAs/PLs | 监查员/项目负责人交接表 |
| Handover Checklist of Investigator Site File/Monitor File for CRAs | 监查员研究文件交接核查清单 |
| Handover Checklist of Investigator Site File/Monitor File for CRAs | 监查员研究文件交接核查清单 |
| Master Randomization List after Un-blinding | 揭盲后的总随机表 |
| Randomization List Release Form | 揭盲记录表 |
| Emergency Un-blinding Form | 紧急揭盲记录表 |
| IEC Submission Letter /IEC Approval Form & Member List, and Updates | 伦理递交信/伦理批件及组成名单及更新 |
| Internal IVD Dispatch Form | 内部试剂发放表 |
| Internal Study Material Dispatch Form | 内部试验用品发放表 |
| Others | 其他 |
| Others | 其他 |
| Others（Industrial Standard） | 其他（产品标准） |
| Qualified Certification of Manufactory, Entrustment | 企业三证、申办方委托证明 |
| Control Checklist for Study Initiation Visit | 启动访视批准表 |
| IVD Management Agreement before Study Initiation | 启动前试剂管理签字页 |
| Control Checklist for First IVD Shipment | 启动前首次试剂发放批准表 |
| Study Authorization Form & Updates | 任务授权表及更新 |
| Record of Retained Biologic Samples | 生物样本保存记录 |
| Biologic Sample Temperature Log | 生物样本温度记录 |
| Record of Shipment of Biologic Samples | 生物样本运送记录 |
| Lab Normal Values & Updates | 实验室正常值范围及更新件 |
| Lab Validation/other Certification & Updates | 实验室资质证书 |
| IVD Dispensing/Return/Destruction Form | 试剂当场发放回收销毁记录表 |
| IVD Dispatch Form | 试剂发放表 |
| IVD Supply Tracking Form (CRA) | 试剂供应跟踪记录表（CRA） |
| IVD Supply Tracking Form (PL) | 试剂供应跟踪记录表（PL） |
| IVD Return Form | 试剂回收记录 |
| IVD Inventory Log | 试剂库存表 |
| IVD Temperature Log | 试剂温度记录表 |
| IVD Destruction Document | 试剂销毁记录 |
| Product Recall (if applicable) | 试剂召回（如果适用） |
| Protocol/Protocol Modification(Approved) | 试验方案及方案修正版 |
| ICF/CRF/Subject Diary Approval Form & Updates | 试验基本文档批准表及更新 |
| Essential Documents Review Comments | 试验基本文档审核意见表 |
| Record of Study Essential Documents Review | 试验基本文档审阅记录 |
| Study Close Down Form | 试验结束访视表 |
| Study Close-down | 试验结束阶段 |
| Study Close-down | 试验结束阶段 |
| Confirmation Letter/ Pre-Study Contact Form/Follow-up Letter | 试验开始前访视确认函/试验开始前访视表/试验开始前访视跟进函 |
| Initiation Meeting (Confirmation Letter, Agenda, Attendance Record, Minutes, Initiation visit, Follow-up Letter) | 试验启动会（确认函、日程、出席签到、会议记录、启动访视表、跟进函） |
| Study Specific Document | 试验特定文件 |
| Study Specific Document | 试验特定文件 |
| Study Related Material Supply Form | 试验相关用品供应表 |
| Study Related Material Return Form | 试验相关用品回收记录 |
| Study Related Material Destruction Form | 试验相关用品销毁记录 |
| Sample of Labels Attached to Product Container & Label Design Approval | 试验药物标签及设计批准表 |
| Study Start-up and on-going | 试验准备及进行阶段 |
| Study Start-up and on-going | 试验准备及进行阶段 |
| Clinical Study Report | 试验总结报告 |
| Database Closure Form | 数据关闭表 |
| Database Re-Opening Form | 数据库再次打开表 |
| Treatment Allocation /Emergency Code Documentation Form | 随机/应急信封记录表 |
| Statistical Analysis Report | 统计分析报告 |
| Statistical Analysis Plan & Updates | 统计分析计划及更新件 |
| Relevant Correspondence (incl. email, Progress Report, Newsletter, Contact Report) | 相关联系往来沟通记录（包括电子邮件、进展报告、通讯、沟通报告等） |
| SUSAR and other Safety Information | 向EC上报的SUSAR和其他药物安全信息 |
| Name List of PLs & CRAs | 项目负责人及监查员名单 |
| Handover Checklist of Trial Master File for PLs | 项目负责人试验总文档交接核查清单 |
| Project Management Plan & Updates | 项目管理计划及更新 |
| Co-visit Report | 协同访视报告 |
| Co-visit Tracking Log | 协同访视追踪表 |
| Site Study Report | 研究分中心报告 |
| Confirmation of Study Close-Down (PL) | 研究结束确认表（PL） |
| Investigator Request for Change Form | 研究者更正数据申请表 |
| Investigator Meeting (Agenda, Attendance Record, Minutes) | 研究者会议（日程、出席签到、会议记录） |
| Confirmation of Receipt of Products by Investigator | 研究者接收试剂签收 |
| Investigator Training Record | 研究者培训记录 |
| Investigator’s Brochure & Updates/Product Package Insert | 研究者手册及更新/产品说明书 |
| Confirmation Letter /Selection of Investigator/Follow-up Letter | 研究者选择确认函/研究者选择评估表/研究者选择跟进函 |
| SAE Report to Sponsor/EC/SFDA/PFDA | 研究者致申办者/EC/SFDA/PFDA的严重不良事件报告 |
| No. of Investigators & CV of Investigator(s) / Certificate & Updates | 研究者总数及研究者简历/资质证书及更新 |
| Signed Agreement with Sites (contract)/CDA | 研究中心合同/保密协议 |
| Subject Diary (Sample) | 样本日记（样本） |
| Subject Identification Code List Final / Completed | 样本入组编码（完整）（即样本入选情况一览表） |
| Subject Screening Log | 样本筛选表 |
| Patient Recruitment and Retention Plan | 样本招募和保留计划 |
| Certificate(s) of Analysis of Products & Updates | 药检报告及新的药检报告 |
| Medical Monitoring Plan | 医学监查计划 |
| Suspected Serious Non-Compliance Form | 疑似严重违反GCP记录表 |
| Signed and Dated CRFs | 已签字的CRF |
| Discrepancy Report | 已签字的差异表 |
| Handover Checklist with Sponsor | 与申办方交接记录 |
| Source Document (Sample) | 原始病历（样本） |
| Advertisement for Subject Recruitment | 招募广告 |
| Informed Consent Form & Updates (Sample) | 知情同意书及更新件（样本） |
| Informed Consent QC Checklist | 知情同意书要素核查 |
| Notification to EC for Study Completion | 致伦理信告试验结束 |
| Reports to Authority/IEC (Interim or Annual) | 中期或年度报告 |
| Site Specific Document | 中心特定文件 |
| Site Specific Document | 中心特定文件 |
| Document Dispatch Form | 资料发送签收单 |
| Printing Request Form | 资料印刷申请表 |
| ID | 鉴定 |
| MIC | 最小抗菌药浓度 |
| Phoenix ID Broth | 不译 |
| Phoenix AST Broth | 不译 |
| Phoenix AST Indicator | 不译 |
| BD PhoenixSpec Nephelometer | BD PhoenixSpec比浊仪 |
| Phoenix GP Panel | Phoenix GP板条 |
| Phoenix Inoculation Station | Phoenix接种台 |
| well | 微孔 |
| isolate | 分离菌株 |
| Antimicrobial Susceptibility Testing System | 药敏试验系统 |
| Accuracy Testing | 准确性试验 |
| essential agreement (EA) | MIC总一致率 |
| category agreement (CA) | 敏感性判定一致率（CA） |
| error rate | 敏感性判定错误率 |
| sensitivity | 灵敏度 |
| specificity | 特异性 |
| AST-Only Panel | 仅AST型板条 |
| Broth Microdilution Method (BMD) | 肉汤微量稀释法（BMD） |
| Challenge Set Isolates | 挑战用分离菌株集 |
| Evaluable EA | 可评估的EA |
| Fresh isolate | 新鲜分离菌株 |
| Gentamicin Screen (GMS) | 庆大霉素筛选法 |
| High Level Aminoglycoside Resistance (HLAR) | 氨基苷类高水平耐药性（HLAR） |
| ID/AST Combination (Combo) Panel | ID/AST复合（Combo）板条 |
| Intermediate interpretive category | 中间类别解读结果 |
| Major error (ME) | 重大错误（ME） |
| Minimum inhibitory concentration (MIC) | 最小抗菌药浓度（MIC） |
| Minor error (MIE) | 小错误（MIE） |
| On-scale result | 量程范围内结果 |
| Recent isolate | 近期分离菌株 |
| Resistant interpretive category | 耐药类别解读结果 |
| Sensitive interpretive category | 药敏类别解读结果 |
| Skipped Well | 跳过的孔 |
| Stock isolate | 储备分离菌株 |
| Streptomycin Screen (STS) | 链霉素筛选法（STS） |
| TSA II | TrypticaseÔ带有5%羊血的胰蛋白胨大豆琼脂 |
| Very major error (VME) | 非常重大错误（VME） |
| “X” MIC | “X” MIC |
| site | 试验中心（或研究中心） |
七、百思路得术语表
| English | 中文 |
|---|---|
| transducer | 探头 |
| user guide/guide | 穿刺架（专指产品名称时） |
| needle guide | 穿刺架 |
| plane guide | 平面参考线 |
| biopsy guide | 穿刺架 |
| puncture guide | 穿刺架 |
| Biopsy and Needle guides | 穿刺架 |
| Needle & Puncture guides | 穿刺架 |
| Hoods and Biopsy & dummy channel brackets | 套件和活检通道支架 |
网络安全术语系列
| English | 中文 |
|---|---|
| ALOF | 自动注销 |
| AUDT | 审核控制 |
| AUTH | 授权 |
| CNFS | 安全特性配置 |
| CSUP | 网络安全产品升级 |
| DIDT | 健康数据身份信息去除 |
| DTBK | 数据备份与灾难恢复 |
| EMRG | 紧急访问 |
| IGAU | 健康数据完整性与真实性 |
| MLDP | 恶意软件探测与防护 |
| NAUT | 网络节点鉴别 |
| PAUT | 人员鉴别 |
| PLOK | 物理锁 |
| RDMP | 第三方组件维护计划 |
| SAHD | 系统与应用软件硬化 |
| SGUD | 安全指导 |
| STCF | 健康数据存储保密性 |
| TXCF | 传输保密性 |
| TXIG | 传输完整性 |
八、诺沃兰
| English | 中文 |
|---|---|
| Cassette / Cartridge | 暗盒/样品盒 |
| Fluidic Compartment | 射流隔室 |
| Thermal block | 热模块 |
| Enclosure Deck Surface | 外壳甲板面 |
| Plenum | 增压室 |
| weak tab hinge | 弱袢（tab hinge）结合度稍弱 |
| English | 中文 |
|---|---|
| Mammotome Dual Vacuum Assisted Biopsy (VAB) System | 双向真空辅助乳房活检与旋切系统 |
| Mammotome Revolve 8G EX Ultrasound Probe | 一次性使用乳房穿刺旋切（探）针 |
| Specimen Management System | 样本管理装置 |
| Protective Cap | 保护帽 |
| Sample Aperture | 取样槽 |
| Cutter | 旋切刀 |
| Tissue Sample View Window | 组织样本观察窗 |
| Alignment Indicator | 对准指示符 |
| Fluid Management Manifold | 液体分离管 |
| Single Sample Tray | 单个样本托盘 |
| Tray 1 | 托盘1 |
| Tray 2 | 托盘3 |
| Tray 3 | 托盘2 |
| Probe Tip | 旋切刀尖端 |
| Trocar Shaft | 穿刺针轴 |
| Distal Gear | 远端齿轮 |
| Probe Body | 旋切刀主体 |
| Locking/Release Tab | 锁定/释放键 |
| Vacuum Tube Set | 真空管套件 |
| Sleeve Retainer | 护套 |
| Sterile Sleeve | 无菌套管 |
| Sleeve Ring | 护套环 |
| Probe | 穿刺旋切针 |
| Translation/ Window-seal assy/ Drive nut | 平移/窗口 – 密封组件/驱动螺母 |
| Drive nut Assy-Cutter Assy (UV) | 驱动螺母组件 – 旋切刀组件（UV） |
| Needle Crimping | 针头压接 |
| Needle Assy and elbow (UV-Crimping) /Lateral Vacauum Tube Assy | 针头组件和弯头（UV-压接）/横向真空管组件 |
| Ensamble Needle with Lateral Vacuum Tubing Assembly | 将针头与横向真空管件组件装配在一起 |
| Ensamble Transfer with axial Vacuum Tubing Assembly | 将转接装置与轴向真空管件组件装配在一起 |
| Latch Press | 闩锁按压 |
| Sample Management Assy/ Sample Management Leak Test | 样品管理组件/样品管理泄漏测试 |
| Final Assy and Final Press | 最终装配和最终按压 |
| Functional Tester | 功能测试仪 |
| Sleeve Assy | 套筒组件 |
| Folder Assy Probe/Tube Set/ Sleeve | 折叠包装组件穿刺旋切（探）针刀头/管套件/套筒 |
| Final packaging (Pouch assy and seal) | 最终包装（袋装配和密封） |
AbacusBio术语
| English | 中文 |
|---|---|
| knowledge transfer project | 知识转化项目 |
| target breeding | 有针对性的育种目标 |
| target breed | 目标品种 |
| market engagement | 市场参与 |
| Economic selection index | 经济选择指标 |
| production opportunities | 生产机会 |
| dissemination | 规模放大 |
| genetic groups | 遗传群体 |
| composite | 复合杂交品种 |
| Stabilising a breed | 稳定品种 |
| Faecal Egg Counting | 粪便卵计数 |
| objective measurements | 目标衡量指标 |
| The power of progeny testing | 后裔测定 |
| Rate of genetic progress | 遗传进展速率 |
| Pedigree | 系谱 |
| level of inbreeding | 近交水平 |
| Mate allocation | 交配配置 |
| Visual evaluation | 外貌鉴定 |
| Performance | 性状 |
| English | 中文 |
|---|---|
| Amplification | 扩繁 |
核医学专业术语
| English | 中文 |
|---|---|
| MIBI | 甲氧基异丁基异腈 |
| Exercise study | 运动负荷成像 |
| Extra cardiac activity | 心外活性 |
| Nuclear cardiology laboratories | 核医学检查 |
| Coronary CT Angiography | 冠脉CT血管造影（CCTA） |
| Hybrid imaging | 混合成像 |
| Hard events | 硬终点 |
| Contractile reserve | 收缩储备 |
| Revascularization (CR) | 血运重建（CR） |
| Myocardial perfusion scintigraphy | 心肌灌注显像 |
| Heart-to-extra-cardiac ratios | 心脏-心外活度比值 |
| Mechanical dyssynchrony | 机械不同步 |
| Normalization | 同步化治疗 |
| Cardiac death | 心源性死亡 |
| Non-fatal myocardial infarction (MI) | 非致死性心肌梗死（MI） |
| Unstable angina pectoris (UAP) | 不稳定性主绞痛（UAP） |
| Severe heart failure | 重度心力衰竭 |
| Non-contrast computed tomography (CT) as | 平扫计算机体层成像（CT） |
VERITON术语表
| 英文 | 中文翻译，请确认 |
|---|---|
| Windowing | 窗口 |
| Window width | 窗宽 |
| Feet First Prone | 脚先进，俯卧位(Feet First Prone) |
| Feet First Supine | 脚先进，仰卧位(Feet First Supine) |
| Slice | 层/排 |
| Slice thickness | 层厚 |
| 64 Slices | 64层/排 |
| Ring rotation | （机架）环旋转 |
| Swivel rotation | 摇摆式旋转 |
| Localizers | 定位扫描（若后接scan，则统一翻译成定位扫描；若是一个程序名称，则保留英文不译） |
| Table | 扫描床 |
| Bed | 床位 |
| Bed positioning | 床位定位 |
| Bed position | 床位位置 |
| Multi-Bed | 多检查床 |
| orientation | 朝向 |
| Patient Position | 患者体位 |
| Tube is COLD | 射线管低温 |
| Tube is WARM | 射线管已热 |
| Study | 扫描检查 |
| Exam | 检查 |
| Standby Controls | 待机控制 |
| Ground Label | 接地标签 |
| Inside Door | 门内侧 |
| P-Scope | P-Scope |
| Modality | 模式-形容某类产品，通常可以翻译成产品
形容某类图像，可以翻译成模态 |
| Scan Pattern | 扫描样式 |
| Scan mode | 扫描模式 |
| Persistence | 余辉 |
| Monitor | 显示器（或监护仪，如ECG监护仪） |
| Display | 显示器/显示界面/显示屏
（根据语境灵活翻译） |
| Persistence display | 余辉显示 |
| Screen | 界面（指物理显示屏时翻译成屏幕） |
| Main screen | 主界面 |
| Pane | 窗格 |
| Handle | 手柄 |
| Jig Interface | 夹具接口 |
| temperature level | 温度级别 |
| intermediate Reports | （各检查床床位的）直接报告 |
| stitched Reports | （多检查床扫描）组合报告 |
| Transfer of data | 数据传输 |
| Preconfigured repositories | 预配置的存储库 |
| Document | 文档 |
| Documentation | 文档 |
| File | 文件 |
| Log Files | 日志文件 |
| Validate | 确认 |
| Verify | 验证 |
| Filter | 滤波器 |
| data filters | 数据筛选器 |
| Date Filter | 日期筛选器 |
| Active | 激活 |
| inactive | 非激活 |
| expected delay | 预期延迟 |
| Time-to-Cold | Time-to-Cold（冷却所需时间） |
| absolute target | 绝对目标值 |
| time window | 时间窗 |
| Tube Heat | 射线管温度 |
| worst-case | 最坏情况 |
| scenario | 场景（或情况） |
| Counts in ROI | Counts in ROI（ROI内计数值） |
| Focus ROI | 焦点ROI |
| tracer bolus | 示踪剂 |
| radioactive fiducial marker | 放射性基准标志 |
| Frame Duration | Frame Duration（影像帧时长） |
| Splash view | 打散排列视图 |
| ROI circle | ROI环 |
| Bottom views | 底视图 |
| PL (Penalized Likelihood) | PL（惩罚概率） |
| Cine | 电影扫描（Cine） |
| Scatter Correction | 散射校正 |
| technetium isotope | 锝同位素 |
| Dual-Energy Window | 双能窗口 |
| Photopeak | Photopeak（能峰） |
| Down Scatter | Down Scatter（下散射） |
| Down-Scatter Correction | Down-Scatter Correction（下散射校正） |
| Anatomical groups | 解剖组 |
| anatomic location | 解剖位置 |
| Assign Multiple | Assign Multiple（多重协议关联） |
| Uncheck All | Uncheck All（取消全选） |
| second monitor | 副监视器 |
| parent protocol properties and limitations | 母协议的特性及局限性 |
| default factory protocols | 出厂默认协议 |
| Reorder Scans | Reorder Scans（对扫描重新排序） |
| Multi-Bed Acquisition | Multi-Bed Acquisition（多检查床采集） |
| ROI Ratio | ROI Ratio （ROI比率） |
| Computer | 计算机 |
| on-the-fly | 实时 |
| Count Optimization | Count Optimization（计数优化） |
| Dynamic Acquisition | Dynamic Acquisition（动态采集） |
| Time per Frame | Time per Frame（每帧所需时间） |
| Link to | 关联 |
| technical dose-saving factors | 技术性降线参数 |
| Automatic Exposure Correction | 自动曝光校正 |
| current modulation | 电流调制 |
| Wedge/bowtie filter size | 楔形/蝴蝶结形滤波器尺寸 |
| Protocol Entry | 协议条目 |
| Reformat | Reformat（重构） |
| Slice Increment | Slice Increment（层厚步进值） |
| Weighting factor | 加权因子 |
| single plan box | 单一重建计划方案 |
| default Length | 默认长度 |
| Myocardium Dynamic | Myocardium Dynamic（心肌动态） |
| Rest Dynamic | Rest Dynamic（静息动态） |
| SPECT Gated | SPECT Gated（SPECT门控） |
| Rest Gated | Rest Gated（静息门控） |
| Stress Dynamic | Stress Dynamic（负荷动态） |
| Stress Gated | Stress Gated（负荷门控） |
| Three Phase Bone | Three Phase Bone（骨三相） |
| Flow | Flow（血流） |
| Bloodpool | Bloodpool（血池） |
| Bone Phase | Bone Phase（骨相） |
| Gastric Emptying | Gastric Emptying（胃排空） |
| Gastric Accommodation | Gastric Accommodation（胃适应性舒张） |
| Salivary Glands | Salivary Glands（唾液腺） |
| Esophogeal | Esophogeal（食道） |
| Renogram | Renogram（肾图） |
| Mebrofenin | Mebrofenin |
| DISIDA (Disofenin) | DISIDA (Disofenin) |
| Tetrosfosmin | Tetrosfosmin |
| Hepatobiliary Hida | Hepatobiliary Hida（肝胆HIDA） |
| 111In Pentetreotide | 111In Pentetreotide |
| Pedi Three Phase Bone | Pedi Three Phase Bone（儿科三相骨骼） |
| Pedi Renogram | Pedi Renogram（儿科肾图） |
| usage patterns | 使用样式（指使用人体样式图） |
| system incident | 系统事故 |
ASP清洗消毒机术语
| English | 中文 |
|---|---|
| Cycle | 循环 |
| Basin | 消毒盆 |
| Detergent | 洗涤剂 |
| Prime | 预充 |
| Self disinfection (SD) | 自消毒（SD） |
| Thermal SD | 热自消毒 |
| Rinse | 漂洗 |
| Flush | 冲洗 |
| Wash | 清洗 |
| Walkthrough | 走查 |
| Sequence | 序列 |
| Purge | 净化（或作吹扫） |
| Service | 服务 |