北京译海腾飞翻译公司
联系电话:010-81534401,65677906
公司传真:010-65677906
项目经理:13241835386
联系信箱:81534401@163.com
联系地址:北京市朝阳区南郎家园1号大北写字楼512室(国贸桥东南角,紧邻招商局、海航大厦)
邮政编码:100022
公司网址:http://www.bjyhtf.com
(《联邦规章典集》第21篇第868部[21CFR868])
目录
节号 | 中译文 | 原英文 |
A亚部――总则(General Provisions) | ||
868.1 | 范围 | Scope |
868.3 | 有关上市前批准生效日期的要求 | Effective dates of requirement for premarket approval |
868.9 | 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) | ||
868.1030 | 手动痛觉计 | Manual algesimeter |
868.1640 | 电动痛觉计 | Powered algesimeter |
868.1075 | 氩气分析仪 | Argon gas analyzer |
868.1100 | 动脉血取样工具箱 | Arterial blood sampling kit |
868.1120 | 心内血氧基血红素浓度分析仪 | Indwelling blood oxyhemoglobin concentration analyzer |
868.1150 | 心内血二氧化碳分压 (PCO2) 分析仪 | Indwelling blood carbon dioxide partial pressure (PCO2) analyzer |
868.1170 | 心内血氢离子浓度 (pH) 分析仪 | Indwelling blood hydrogen ion concentration (pH) analyzer |
868.1200 | 心内血氧分压 (PO2) 分析仪 | Indwelling blood oxygen partial pressure (PO2) analyzer |
868.1400 | 二氧化碳气体分析仪 | Carbon dioxide gas analyzer |
868.1430 | 一氧化碳气体分析仪 | Carbon monoxide gas analyzer |
868.1500 | 安氟醚气体分析仪 | Enflurane gas analyzer |
868.1575 | 气体收集容器 | Gas collection vessel |
868.1620 | 氟烷气体分析仪 | Halothane gas analyzer |
868.1640 | 氦气分析仪 | Helium gas analyzer |
868.1670 | 氖气分析仪 | Neon gas analyzer |
868.1690 | 氮气分析仪 | Nitrogen gas analyzer |
868.1700 | 一氧化二氮气体分析仪 | Nitrous oxide gas analyzer |
868.1720 | 氧气分析仪 | Oxygen gas analyzer |
868.1730 | 耗氧量计算机 | Oxygen uptake computer |
868.1750 | 压力体积描记器 | Pressure plethysmograph |
868.1760 | 容量描记器 | Volume plethysmograph |
868.1780 | 吸气呼吸道压力计 | Inspiratory airway pressure meter |
868.1800 | 鼻气流计 | Rhinoanemometer |
868.1840 | 诊断用肺活量计 | Diagnostic spirometer |
868.1850 | 监测用肺活量计 | Monitoring spirometer |
868.1860 | 肺活量测定用最大气流量计 | Peak-flow meter for spirometry |
868.1870 | 气体容积定标器 | Gas volume calibrator |
868.1880 | 肺功能数据计算器 | Pulmonary-function data calculator |
868.1890 | 预测用肺功能值计算器 | Predictive pulmonary-function value calculator |
868.1900 | 诊断用肺功能说明计算器 | Diagnostic pulmonary-function interpretation calculator |
868.1910 | 食道听诊器 | Esophageal stethoscope |
868.1920 | 电导体式食道听诊器 | Esophageal stethoscope with electrical conductors |
868.1930 | 听诊器头 | Stethoscope head |
868.1965 | 转换阀 | Switching valve (ploss) |
868.1975 | 水蒸气分析仪 | Water vapor analyzer |
C亚部――监测装置(Monitoring Devices) | ||
868.2025 | 超声空气栓子监测器 | Ultrasonic air embolism monitor |
868.2300 | 波登表流量计 | Bourdon gauge flowmeter |
868.2320 | 非补偿式thorpe管流量计 | Uncompensated thorpe tube flowmeter |
868.2340 | 补偿式thorpe管流量计 | Compensated thorpe tube flowmeter |
868.2350 | 气体校准流量计 | Gas calibration flowmeter |
868.2375 | 呼吸频率监测器 | Breathing frequency monitor |
868.2377 | 呼吸暂停监测器 | Apnea monitor |
868.2380 | 氧化氮分析仪 | Nitric oxide analyzer |
868.2385 | 二氧化氮分析仪 | Nitrogen dioxide analyzer |
868.2450 | 肺水监测器 | Lung water monitor |
868.2480 | 皮肤二氧化碳 (PcCO2) 监测器 | Cutaneous carbon dioxide (PcCO2) monitor |
868.2500 | 皮肤氧气 (PcO2) 监测器 | Cutaneous oxygen (PcO2) monitor |
868.2550 | 呼吸流速计 | Pneumotachometer |
868.2600 | 呼吸道压力监测器 | Airway pressure monitor |
868.2610 | 气体压力计 | Gas pressure gauge |
868.2620 | 气体压力定标器 | Gas pressure calibrator |
868.2700 | 压力调节器 | Pressure regulator |
868.2775 | 末梢神经电动刺激仪 | Electrical peripheral nerve stimulator |
868.2875 | 压差传感器 | Differential pressure transducer |
868.2885 | 气流传感器 | Gas flow transducer |
868.2900 | 气压传感器 | Gas pressure transducer |
D-E亚部 [保留] (Reserved) | ||
F亚部 ――治疗设备(Therapeutic Devices) | ||
868.5090 | 紧急呼吸道针 | Emergency airway needle |
868.5100 | 鼻咽导气管 | Nasopharyngeal airway |
868.5110 | 口咽导气管 | Oropharyngeal airway |
868.5115 | 减轻急性上呼吸道梗塞用设备 | Device to relieve acute upper airway obstruction |
868.5120 | 麻醉引流导管 | Anesthesia conduction catheter |
868.5130 | 麻醉引流过滤器 | Anesthesia conduction filter |
868.5140 | 麻醉引流工具箱 | Anesthesia conduction kit |
868.5150 | 麻醉引流针 | Anesthesia conduction needle |
868.5160 | 麻醉或痛觉丧失用气体麻醉机 | Gas machine for anesthesia or analgesia |
868.5165 | 氧化氮给药装置 | Nitric oxide administration apparatus |
868.5170 | 喉气管局部麻醉涂药器 | Laryngotracheal topical anesthesia applicator |
868.5180 | 摇床 | Rocking bed |
868.5220 | 吹气瓶 | Blow bottle |
868.5240 | 麻醉呼吸管路 | Anesthesia breathing circuit |
868.5250 | 呼吸管路循环器 | Breathing circuit circulator |
868.5260 | 呼吸管路细菌过滤器 | Breathing circuit bacterial filter |
868.5270 | 呼吸系统加热器 | Breathing system heater |
868.5280 | 呼吸管支撑物 | Breathing tube support |
868.5300 | 二氧化碳吸收剂 | Carbon dioxide absorbent |
868.5310 | 二氧化碳吸收体 | Carbon dioxide absorber |
868.5320 | 储气袋 | Reservoir bag |
868.5330 | 呼吸气体混合器 | Breathing gas mixer |
868.5340 | 鼻氧套管 | Nasal oxygen cannula |
868.5350 | 鼻氧导管 | Nasal oxygen catheter |
868.5365 | 心脏或肺部治疗用体位椅 | Posture chair for cardiac or pulmonary treatment |
868.5375 | 加热和湿气冷凝器 (人造鼻) | Heat and moisture condenser (artificial nose) |
868.5400 | 电麻醉装置 | Electroanesthesia apparatus |
868.5420 | 乙醚钩 | Ether hook |
868.5430 | 气体净化装置 | Gas-scavenging apparatus |
868.5440 | 便携式氧发生器 | Portable oxygen generator |
868.5450 | 呼吸气体增湿器 | Respiratory gas humidifier |
868.5460 | 家用治疗增湿器 | Therapeutic humidifier for home use |
868.5470 | 高压舱 | Hyperbaric chamber |
868.5530 | 柔韧性喉镜 | Flexible laryngoscope |
868.5540 | 刚性喉镜 | Rigid laryngoscope |
868.5550 | 麻醉剂防毒面罩 | Anesthetic gas mask |
868.5560 | 防毒面罩头带 | Gas mask head strap |
868.5570 | 非再呼吸性面罩 | Nonrebreathing mask |
868.5580 | 氧气面罩 | Oxygen mask |
868.5590 | 换气面罩 | Scavenging mask |
868.5600 | 文氏管面罩 | Venturi mask |
868.5610 | 长期肺部支持用的膜式肺 | Membrane lung for long-term pulmonary support |
868.5620 | 呼吸吹口 | Breathing mouthpiece |
868.5630 | 喷雾器 | Nebulizer |
868.5640 | 药用非换气式喷雾器 (雾化器) | Medicinal nonventilatory nebulizer (atomizer) |
868.5650 | 食道闭塞器 | Esophageal obturator |
868.5655 | 便携式液氧装置 | Portable liquid oxygen unit |
868.5665 | 动力叩诊器 | Powered percussor |
868.5675 | 再呼吸设备 | Rebreathing device |
868.5690 | 刺激用肺活量计 | Incentive spirometer |
868.5700 | 非动力氧气帐 | Nonpowered oxygen tent |
868.5710 | 电动氧气帐 | Electrically powered oxygen tent |
868.5720 | 支气管套管 | Bronchial tube |
868.5730 | 气管套管 | Tracheal tube |
868.5740 | 气管/支气管差异性换气管 | Tracheal/bronchial differential ventilation tube |
868.5750 | 充气式气管套管袖带 | Inflatable tracheal tube cuff |
868.5760 | 袖带涂铺器 | Cuff spreader |
868.5770 | 气管套管固定装置 | Tracheal tube fixation device |
868.5780 | 套管导入镊子 | Tube introduction forceps |
868.5790 | 气管套管探针 | Tracheal tube stylet |
868.5795 | 气管套管清洁刷 | Tracheal tube cleaning brush |
868.5800 | 气管切开插管和套管袖带 | Tracheostomy tube and tube cuff |
868.5810 | 导气管连接器 | Airway connector |
868.5820 | 牙齿保护器 | Dental protector |
868.5830 | 自体输血装置 | Autotransfusion apparatus |
868.5860 | 压力管道系统和附件 | Pressure tubing and accessories |
868.5870 | 非再呼吸阀 | Nonrebreathing valve |
868.5880 | 麻醉剂蒸发器 | Anesthetic vaporizer |
868.5895 | 连续式呼吸器 | Continuous ventilator |
868.5905 | 非连续式呼吸器 (IPPB) | Noncontinuous ventilator (IPPB) |
868.5915 | 手动急救呼吸器 | Manual emergency ventilator |
868.5925 | 电动急救呼吸器 | Powered emergency ventilator |
868.5935 | 外用负压呼吸器 | External negative pressure ventilator |
868.5955 | 间歇式强制换气附件 | Intermittent mandatory ventilation attachment |
868.5965 | 正呼气末压式呼吸附件 | Positive end expiratory pressure breathing attachment |
868.5975 | 呼吸器管道系统 | Ventilator tubing |
868.5995 | T型排水管 (脱水器) | Tee drain (water trap) |
G亚部 ――其它器械(Miscellaneous) | ||
868.6100 | 麻醉柜、桌或托盘 | Anesthetic cabinet, table, or tray |
868.6175 | 心肺急救车 | Cardiopulmonary emergency cart |
868.6225 | 鼻夹 | Nose clip |
868.6250 | 便携式空气压缩机 | Portable air compressor |
868.6400 | 校准气体 | Calibration gas |
868.6700 | 麻醉凳 | Anesthesia stool |
868.6810 | 气管支气管吸引导管 | Tracheobronchial suction catheter |
868.6820 | 患者体位支持器 | Patient position support |
868.6885 | 医用气体连接部件 | Medical gas yoke assembly |