1、医疗器械中英文对照麻醉学器械 (Anesthesiology Devices)（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 Scope868.3 有关上市前批准生效日期的要求 Effective dates of requirement for premarket approval868.9 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
2、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 algesimeter868.1640 电动痛觉计 Powered algesimeter868.1075 氩气分析仪 Argon gas analyzer868.1100 动脉血取样工具箱 Arterial blood sampling kit868.1120 心内血氧基血红素浓度分析仪 Indwelling blood oxyhemoglobin conce
3、ntration analyzer868.1150 心内血二氧化碳分压 (PCO2) 分析仪 Indwelling blood carbon dioxide partial pressure (PCO2) analyzer868.1170 心内血氢离子浓度 (pH) 分析仪 Indwelling blood hydrogen ion concentration (pH) analyzer868.1200 心内血氧分压 (PO2) 分析仪 Indwelling blood oxygen partial pressure (PO2) analyzer868.1400 二氧化碳气体分析仪 Carbo
4、n dioxide gas analyzer868.1430 一氧化碳气体分析仪 Carbon monoxide gas analyzer868.1500 安氟醚气体分析仪 Enflurane gas analyzer868.1575 气体收集容器 Gas collection vessel868.1620 氟烷气体分析仪 Halothane gas analyzer868.1640 氦气分析仪 Helium gas analyzer868.1670 氖气分析仪 Neon gas analyzer868.1690 氮气分析仪 Nitrogen gas analyzer868.1700 一氧化二
5、氮气体分析仪 Nitrous oxide gas analyzer868.1720 氧气分析仪 Oxygen gas analyzer868.1730 耗氧量计算机 Oxygen uptake computer868.1750 压力体积描记器 Pressure plethysmograph868.1760 容量描记器 Volume plethysmograph868.1780 吸气呼吸道压力计 Inspiratory airway pressure meter868.1800 鼻气流计 Rhinoanemometer868.1840 诊断用肺活量计 Diagnostic spirometer8
6、68.1850 监测用肺活量计 Monitoring spirometer868.1860 肺活量测定用最大气流量计 Peak-flow meter for spirometry868.1870 气体容积定标器 Gas volume calibrator868.1880 肺功能数据计算器 Pulmonary-function data calculator868.1890 预测用肺功能值计算器 Predictive pulmonary-function value calculator868.1900 诊断用肺功能说明计算器 Diagnostic pulmonary-function inte
7、rpretation calculator868.1910 食道听诊器 Esophageal stethoscope868.1920 电导体式食道听诊器 Esophageal stethoscope with electrical conductors868.1930 听诊器头 Stethoscope head868.1965 转换阀 Switching valve (ploss)868.1975 水蒸气分析仪 Water vapor analyzerC 亚部监测装置（Monitoring Devices）868.2025 超声空气栓子监测器 Ultrasonic air embolism m
8、onitor868.2300 波登表流量计 Bourdon gauge flowmeter868.2320 非补偿式 thorpe 管流量计 Uncompensated thorpe tube flowmeter868.2340 补偿式 thorpe 管流量计 Compensated thorpe tube flowmeter868.2350 气体校准流量计 Gas calibration flowmeter868.2375 呼吸频率监测器 Breathing frequency monitor868.2377 呼吸暂停监测器 Apnea monitor868.2380 氧化氮分析仪 Nitr
9、ic oxide analyzer868.2385 二氧化氮分析仪 Nitrogen dioxide analyzer868.2450 肺水监测器 Lung water monitor868.2480 皮肤二氧化碳 (PcCO2) 监测器 Cutaneous carbon dioxide (PcCO2) monitor868.2500 皮肤氧气 (PcO2) 监测器 Cutaneous oxygen (PcO2) monitor868.2550 呼吸流速计 Pneumotachometer868.2600 呼吸道压力监测器 Airway pressure monitor868.2610 气体压
10、力计 Gas pressure gauge868.2620 气体压力定标器 Gas pressure calibrator868.2700 压力调节器 Pressure regulator868.2775 末梢神经电动刺激仪 Electrical peripheral nerve stimulator868.2875 压差传感器 Differential pressure transducer868.2885 气流传感器 Gas flow transducer868.2900 气压传感器 Gas pressure transducerDE 亚部 保留 (Reserved)F 亚部 治疗设备（T
11、herapeutic Devices）868.5090 紧急呼吸道针 Emergency airway needle868.5100 鼻咽导气管 Nasopharyngeal airway868.5110 口咽导气管 Oropharyngeal airway868.5115 减轻急性上呼吸道梗塞用设备 Device to relieve acute upper airway obstruction868.5120 麻醉引流导管 Anesthesia conduction catheter868.5130 麻醉引流过滤器 Anesthesia conduction filter868.5140
12、麻醉引流工具箱 Anesthesia conduction kit868.5150 麻醉引流针 Anesthesia conduction needle868.5160 麻醉或痛觉丧失用气体麻醉机 Gas machine for anesthesia or analgesia868.5165 氧化氮给药装置 Nitric oxide administration apparatus868.5170 喉气管局部麻醉涂药器 Laryngotracheal topical anesthesia applicator868.5180 摇床 Rocking bed868.5220 吹气瓶 Blow bo
13、ttle868.5240 麻醉呼吸管路 Anesthesia breathing circuit868.5250 呼吸管路循环器 Breathing circuit circulator868.5260 呼吸管路细菌过滤器 Breathing circuit bacterial filter868.5270 呼吸系统加热器 Breathing system heater868.5280 呼吸管支撑物 Breathing tube support868.5300 二氧化碳吸收剂 Carbon dioxide absorbent868.5310 二氧化碳吸收体 Carbon dioxide abs
14、orber868.5320 储气袋 Reservoir bag868.5330 呼吸气体混合器 Breathing gas mixer868.5340 鼻氧套管 Nasal oxygen cannula868.5350 鼻氧导管 Nasal oxygen catheter868.5365 心脏或肺部治疗用体位椅 Posture chair for cardiac or pulmonary treatment868.5375 加热和湿气冷凝器 (人造鼻) Heat and moisture condenser (artificial nose)868.5400 电麻醉装置 Electroanes
15、thesia apparatus868.5420 乙醚钩 Ether hook868.5430 气体净化装置 Gas-scavenging apparatus868.5440 便携式氧发生器 Portable oxygen generator868.5450 呼吸气体增湿器 Respiratory gas humidifier868.5460 家用治疗增湿器 Therapeutic humidifier for home use868.5470 高压舱 Hyperbaric chamber868.5530 柔韧性喉镜 Flexible laryngoscope868.5540 刚性喉镜 Rig
16、id laryngoscope868.5550 麻醉剂防毒面罩 Anesthetic gas mask868.5560 防毒面罩头带 Gas mask head strap868.5570 非再呼吸性面罩 Nonrebreathing mask868.5580 氧气面罩 Oxygen mask868.5590 换气面罩 Scavenging mask868.5600 文氏管面罩 Venturi mask868.5610 长期肺部支持用的膜式肺 Membrane lung for long-term pulmonary support868.5620 呼吸吹口 Breathing mouthpi
17、ece868.5630 喷雾器 Nebulizer868.5640 药用非换气式喷雾器 (雾化器 ) Medicinal nonventilatory nebulizer (atomizer)868.5650 食道闭塞器 Esophageal obturator868.5655 便携式液氧装置 Portable liquid oxygen unit868.5665 动力叩诊器 Powered percussor868.5675 再呼吸设备 Rebreathing device868.5690 刺激用肺活量计 Incentive spirometer868.5700 非动力氧气帐 Nonpowe
18、red oxygen tent868.5710 电动氧气帐 Electrically powered oxygen tent868.5720 支气管套管 Bronchial tube868.5730 气管套管 Tracheal tube868.5740 气管/支气管差异性换气管 Tracheal/bronchial differential ventilation tube868.5750 充气式气管套管袖带 Inflatable tracheal tube cuff868.5760 袖带涂铺器 Cuff spreader868.5770 气管套管固定装置 Tracheal tube fixa
19、tion device868.5780 套管导入镊子 Tube introduction forceps868.5790 气管套管探针 Tracheal tube stylet868.5795 气管套管清洁刷 Tracheal tube cleaning brush868.5800 气管切开插管和套管袖带 Tracheostomy tube and tube cuff868.5810 导气管连接器 Airway connector868.5820 牙齿保护器 Dental protector868.5830 自体输血装置 Autotransfusion apparatus868.5860 压力
20、管道系统和附件 Pressure tubing and accessories868.5870 非再呼吸阀 Nonrebreathing valve868.5880 麻醉剂蒸发器 Anesthetic vaporizer868.5895 连续式呼吸器 Continuous ventilator868.5905 非连续式呼吸器 (IPPB) Noncontinuous ventilator (IPPB)868.5915 手动急救呼吸器 Manual emergency ventilator868.5925 电动急救呼吸器 Powered emergency ventilator868.5935
21、外用负压呼吸器 External negative pressure ventilator868.5955 间歇式强制换气附件 Intermittent mandatory ventilation attachment868.5965 正呼气末压式呼吸附件 Positive end expiratory pressure breathing attachment868.5975 呼吸器管道系统 Ventilator tubing868.5995 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
22、托盘 Anesthetic cabinet, table, or tray868.6175 心肺急救车 Cardiopulmonary emergency cart868.6225 鼻夹 Nose clip868.6250 便携式空气压缩机 Portable air compressor868.6400 校准气体 Calibration gas868.6700 麻醉凳 Anesthesia stool868.6810 气管支气管吸引导管 Tracheobronchial suction catheter868.6820 患者体位支持器 Patient position support868.6885 医用气体连接部件 Medical gas yoke assembly
