欧盟医疗器械CE认证（MDD）协调标准
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杨坤
Jun 21, 2009, 10:06:42 PM6/21/09
to nqa_certification
93/42/EEC 协调标准
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 285:2006Sterilization - Steam sterilizers - Large sterilizers消毒 蒸气消毒 大型消毒设备EN 285:1996
EN 375:2001Information supplied by the manufacturer with in vitro diagnostic reagents for professional use由生产商提供的专业用活体外诊断试剂的信息
EN 376:2002Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing生产者在实验室中用自检测诊断试剂提供信息
EN 455-1:2000Medical gloves for single use - Part 1: Requirements and testing for freedom from holes医疗专用手套.防洞要求和试验EN 455-1:1993
EN 455-2:2000Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996)医疗专用手套.物理性能要求和试验EN 455-2:1995
EN 455-3:2006Medical gloves for single use - Part 3: Requirements and testing for biological evaluation医疗专用手套.生物评价的要求和试验EN 455-3:1999
EN 556-1:2001Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-1:2001/AC:2006医疗设备的灭菌.拟被认定为无菌的医疗设备的要求.对最终灭菌设备的要求EN 556:1994 + A1:1998
EN 556-2:2003Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices医疗器械的消毒 标明为“消过毒”的医疗器械的要求 第2部分：消毒处理的医疗器械的要求
EN 591:2001Instructions for use for in vitro diagnostic instruments for professional use专用试管诊断仪的使用说明
EN 592:2002Instructions for use for in vitro diagnostic instruments for self-testing实验室条件下自测试诊断仪的使用说明
EN 737-1:1998Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum医疗气体管道系统.压缩医疗气体用终端设备和真空终端设备
EN 737-4:1998Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems医疗气体管道系统.麻醉气体净化系统的终端设备
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 738-4:1998Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment
EN 738-4:1998/A1:2002医用气体用压力调节器.医疗设备用低压压力调节器Note 3
EN 739:1998Low-pressure hose assemblies for use with medical gases
EN 739:1998/A1:2002医疗气体设备用低压软管组件Note 3
EN 740:1998Anaesthetic workstations and their modules - Particular requirements
EN 740:1998/A1:2004
EN 740:1998/AC:1998麻醉工作站及其工作舱特殊要求Note 3
EN 794-1:1997Lung ventilators - Part 1: Particular requirements for critical care ventilators
EN 794-1:1997/A1:2000肺呼吸器.临危看护呼吸器的特殊要求Note 3
EN 794-3:1998Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
EN 794-3:1998/A1:2005肺呼吸器.紧急情况和移动通风器的特殊要求Note 3
EN 980:2003Graphical symbols for use in the labelling of medical devices医疗器械标签用图形符号EN 980:1996
EN 1041:1998Information supplied by the manufacturer with medical devices医疗产品生产者提供的信息
EN 1060-1:1995Non-invasive sphygmomanometers - Part 1: General requirements
EN 1060-1:1995/A1:2002非侵入式血压计.第1部分:一般要求.修改件A1Note 3
EN 1060-2:1995Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers非侵入式血压表.第2部分:机械血压表的补充要求
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 1060-3:1997Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
EN 1060-3:1997/A1:2005非侵入式血压表.第3部分:电机血压表的补充要求Note 3
EN 1060-4:2004Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers非介入式血压计.第4部分:自动非介入式血压计整体系统精确度测定的试验过程
EN 1089-3:2004Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding可移动式气瓶.气瓶标识(不包括LPG).第3部分:色码EN 1089-3:1997
EN 1280-1:1997Agent specific filling systems for anaesthetic vaporizers - Part 1: Rectangular keyed filling systems
EN 1280-1:1997/A1:2000麻醉气化装置制剂特殊添充系统.拒形键控填充系统Note 3
EN 1281-2:1995Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified)麻醉和呼吸设备圆锥形接头第2部分：螺纹承重连接头
EN 1282-2:2005Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)气体切开插管.第2部分:儿科婴幼儿用管EN 1282-2:1997
EN 1422:1997Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods医用灭菌器.环氧乙烷灭菌器.要求和检验方法
EN 1618:1997Catheters other than intravascular catheters - Test methods for common properties=管内导管除外的其它导管.通用性能的测试法
EN 1639:2004Dentistry - Medical devices for dentistry - Instruments牙科学.牙科用医疗装置.器械EN 1639:1996
EN 1640:2004Dentistry - Medical devices for dentistry - Equipment牙科学.牙科用医疗装置.设备EN 1640:1996
EN 1641:2004Dentistry - Medical devices for dentistry - Materials牙科学.牙科用医疗装置.材料EN 1641:1996
EN 1642:2004Dentistry - Medical devices for dentistry - Dental implants牙科学.牙科用医疗装置.牙科植入物EN 1642:1996
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 1707:1996Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings注射器、针头和其它特定医疗器械用有6%(路厄)锥度的圆锥形配件.锁定配件
EN 1782:1998Tracheal tubes and connectors气管和连接件
EN 1820:2005Anaesthetic reservoir bags (ISO 5362:2000, modified)麻醉贮袋EN 1820:1997
EN 1865:1999Specifications for stretchers and other patient handling equipment used in road ambulances救护车里的担架和其他病人运送设备规范
EN 1970:2000Adjustable beds for disabled persons - Requirements and test methods
EN 1970:2000/A1:2005残疾人用可调整的床.要求和试验方法Note 3
EN 1985:1998Walking aids - General requirements and test methods助步器.一般要求和试验方法
EN ISO 4074:2002Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)天然胶乳橡胶避孕套--技术要求和试验方法EN 600:1996
EN ISO 4135:2001Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)麻醉和呼吸设备.词汇EN ISO 4135:1996
EN ISO 5356-1:2004Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)麻醉和呼吸设备.锥形接头.第1部分:锥体和锥套EN 1281-1:1997
EN ISO 5366-1:2004Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)麻醉和呼吸设备 气管造口插管 第1部分:成人用插管和接头EN 1282-1:1996
EN ISO 5840:2005Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)心血管植入物.心脏瓣膜修复术EN 12006-1:1999
EN ISO 7197:2006Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006)神经外科植入物一次性使用无菌脑积水分流管和组件
EN ISO 7376:2003Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)麻醉和呼吸设备.气管插管术用喉镜EN 1819:1997
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 7396-1:2007Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)医用气体管道系统第1部分：医用压缩气体和真空用管道系统EN 737-3:1998
EN ISO 7396-2:2007Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)医用气体管道系统第2部分：麻醉气体净化处理系统EN 737-2:1998
EN ISO 7439:2002Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)含铜的宫内节育避孕器具.要求、试验
EN ISO 7886-3:2005Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)一次性使用无菌皮下注射器.第3部分:固定剂量免疫接种用自动报废注射器
ENISO 7886-4:2006Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)一次性使用无菌皮下注射器第4部分：具有预防特征重复使用的注射器
EN ISO 8185:1997Humidifiers for medical use - General requirements for humidification systems (ISO 8185:1997)医用增湿器.增湿系统的一般要求
EN ISO 8185:2007Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)医用增湿器.增湿系统的一般要求EN ISO 8185:1997
EN ISO 8359:1996Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)医疗电气设备.医用氧气浓缩器的安全要求
ENISO 8536-4:2007Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)医用输液设备.一次性使用重力输液式输液器
EN ISO 8835-2:2007Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)吸入式麻醉剂系统.第2部分:活性麻醉气体清除系统的传输和容纳系统EN 740:1998
EN ISO 8835-3:2007Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)吸入式麻醉剂系统.第3部分: 麻醉剂呼吸系统EN 740:1998
ENISO 8835-4:2004Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
EN ISO 8835-4:2004/AC:2006吸入式麻醉剂系统.麻醉剂蒸气输送设备
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 8835-5:2004Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)EN ISO 8835-5:2004/AC:2006吸入式麻醉剂系统. 麻醉剂通风设备
EN ISO 9360-1:2000Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)麻醉和呼吸设备.对人体呼吸气体进行加湿的热气和湿气交换器(HMEs).与最小潮量为250 ml的设备一起使用的热气和潮气交换器
EN ISO 9360-2:2002Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)麻醉和呼吸设备.使人体呼吸的气体变湿润用的热和潮气交换器(HMEs).气管造口病人用最小潮流量为250ml的热和潮气交换器
EN ISO 9713:2004Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)神经外科植入物.颅内动脉瘤自闭合夹
EN ISO 9919:2005Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求EN 865:1997
EN ISO 10079-1:1999Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)医用吸引设备.电驱动吸引设备.安全要求EN ISO 10079-1:1996
EN ISO 10079-2:1999Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)医疗吸引设备.手动吸引设备EN ISO 10079-2:1996
EN ISO 10079-3:1999Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)医疗吸引设备.真空或压力吸引设备EN ISO 10079-3:1996
EN ISO 10079-3:1999Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)医疗吸引设备.真空或压力吸引设备EN ISO 10079-3:1996
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 10328:2006Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)修复术.假腿的结构试验.要求和试验报告
EN ISO 10524-1:2006Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)医用气体设备用的压力调节器和带流量计的压力调节器EN 738-1:1997
EN ISO 10524-2:2006Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)与医疗气体共同使用的压力调节器.支管和输送管压力调节器EN 738-2:1998
EN ISO 10524-3:2006Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)医用气体压力调节器第3部分：气瓶阀压力调节器 EN 738-3:1998
EN ISO 10535:2006Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)残疾人用电梯.要求和试验方法EN ISO 10535:1998
EN ISO 10555-1:1996Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995)
EN ISO 10555-1:1996/A1:1999
EN ISO 10555-1:1996/A2:2004一次性使用、无菌管内导管.一般要求Note 3
EN ISO 10651-2:2004Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)医用肺通气机.基本安全和性能的特殊要求.通气机依赖型病人用家庭护理通气机EN 794-2:1997
EN ISO 10651-4:2002Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)肺换气机.对操作人员控制的复苏器的特殊要求
EN ISO 10651-6:2004Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)医用肺通气机.基本安全和性能的特殊要求.家庭保健通气机支撑装置
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 10993-1:2003Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)医疗器械的生物学评价 第1部分:评价和试验
EN ISO 10993-3:2003Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)医疗器械的生物学评价 第3部分:遗传毒性,致癌性毒性和生殖毒性试验EN 30993-3:1993
EN ISO 10993-4:2002Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002)
EN ISO 10993-4:2002/A1:2006医疗器械生物学评价 第4部分 血液交感的试验选择EN 30993-4:1993
Note 3
EN ISO 10993-5:1999Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)医疗器械的生物学评价 第5部分:体外细胞毒性试验EN 30993-5:1994
EN ISO 10993-6:2007Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)医疗器械的生物学评价 第6部分:植入后局部反应试验EN 30993-6:1994
EN ISO 10993-9:1999Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)医疗器械的生物学评价.第9部分:用于可降解产物识别与评定的结构
EN ISO 10993-10:2002Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)
EN ISO 10993-10:2002/A1:2006医疗器械生物学评价 第10部分:刺激与延迟型致敏试验EN ISO 10993-10:1995
Note 3皮肤刺激
眼刺激
皮内刺激
致敏
EN ISO 10993-11:2006Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)医疗器械的生物学评价 第11部分 全身毒性试验EN ISO 10993-11:1995急性全身毒性
热原
内毒素
EN ISO 10993-12:2004Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)医疗器械的生物评定.第12部分:样品制备和参考材料EN ISO 10993-12:1996
EN ISO 10993-13:1998Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)医学化合物的生物评定.第13部分:聚合医学化合物中降解物的质量和数量验证
EN ISO 10993-14:2001Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)医疗器械的生物评定.第14部分:陶瓷降解产品的识别与量化
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 10993-15:2000Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)医疗器械的生物评定.第15部分:金属及合金中降解产物的识别与量化
EN ISO 10993-16:1997Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)医疗器械的生物评定.第16部分:对退化产品和可滤清物的毒理动力学研究的方案和计算
EN ISO 10993-17:2002Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)医疗器械的生物评定.第17部分:可浸出物质容许限值的确定
EN ISO 10993-18:2005Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)医疗器械的生物评定.第18部分:材料的化学表征
EN ISO 11135-1:2007Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)医疗保健产品的灭菌环氧乙烷第1部分：医疗设备灭菌过程的研发、确认和常规控制的要求EN 550:1994
EN ISO 11137-1:2006Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)保健产品的灭菌.辐射.医疗器械消毒程序的建立、确认、和常规控制的要求EN 552:1994
EN ISO 11137-2:2007Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)医疗保健产品灭菌辐照第2部分：灭菌剂量的确定EN 552:1994
EN ISO 11138-2:2006Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)医疗保健产品灭菌生物指示物第2部分：环氧乙烷灭菌过程用生物指示物
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 11138-3:2006Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)医疗保健产品灭菌生物指示物第3部分：温热灭菌过程用生物指示物
EN ISO 11140-1:2005Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)保健产品的灭菌.化学指示剂.第1部分:一般要求EN 867-2:1997
EN ISO 11140-3:2007Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)医疗保健产品灭菌 化学指示物 第3部分:二级指示物 蒸气穿透试验纸EN 867-3:1997
EN ISO 11197:2004Medical supply units (ISO 11197:2004)医用供电装置EN 793:1997
EN ISO 11607-1:2006Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)终端无菌医学设备的包装.原材料、消毒阻挡系统和包装的要求
EN ISO 11607-2:2006Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)终端无菌医学设备的包装.组成、密封和装配过程的确认要求
EN ISO 11737-1:2006Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)医学器材的消毒.微生物学方法.产品上微生物群体的测定
EN ISO 11810-2:2007Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)激光以及与激光相关的设备 手术单和/或患者保护罩的耐激光性试验方法及分类 第2部分：二级点燃EN ISO 11810:2002
EN ISO 11979-8:2006Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006) 眼科植入物眼内透镜第8部分：基础要求EN 13503-8:2000
EN ISO 11990:2003Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)光学和光学仪器.激光和激光设备.气管柄激光抗性的测定EN ISO 11990:1999
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 12006-2:1998Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits非活性外科植入物.心脏和血管植入物的特殊要求.第2部分:人造血管包括心瓣血管接头,
EN 12006-3:1998Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices非活性外科植入物心脏和血管植入物的特殊要求第3部分：血管内植入物,
EN 12010:1998Non-active surgical implants - Joint replacement implants - Particular requirements非活性外科植入物关节替换植入物特殊要求
EN 12011:1998Instrumentation to be used in association with non-active surgical implants - General requirements使用上与非活性外科植入物有关的器具.一般要求
EN 12182:1999Technical aids for disabled persons - General requirements and test methods残疾人技术辅助器具.一般要求和试验方法.
EN 12322:1999In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
EN 12322:1999/A1:2001试管诊断医疗装置.微生物用培养基.培养的效能功率标准Note 3
EN 12342:1998Breathing tubes intended for use with anaesthetic apparatus and ventilators 用于麻醉器和人工呼吸器的呼吸器
EN 12442-1:2000Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk医疗设备生产专用动物产品及其衍生物.风险分析和管理
EN 12442-2:2000Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling医疗设备生产专用动物产品及其衍生物.来源控制、采集和处理
EN 12442-3:2000Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents医疗设备生产专用动物产品及其衍生物.病毒和传染性试剂消除和/或僵化的验证
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 12470-1:2000Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device体温计.第1部分:大刻度的玻璃内有金属液体的温度计
EN 12470-2:2000Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers临床温度计第2部分：相变型（点阵）温度计,
EN 12470-3:2000Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device\体温计.第3部分:大刻度的小型电测温度计的性能(可预测和不可预测的),
EN 12470-4:2000Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement临床温度计 第4部分：用于连续测量的电子温度计的性能
EN 12470-5:2003Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)体温计.第5部分:(大刻度的)耳蜗式红外测温计的性能
EN 12563:1998Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants稳定的外科植入物 关节替代植入物 髋关节替代植入物的特殊要求
EN 12564:1998Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants非有源外科植入物骨接合植入物特殊要求,
EN ISO 12870:2004Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)
EN ISO 12870:2004/AC:2005眼科光学.镜框.要求和试验方法EN ISO 12870:1997
EN 13014:2000Connections for gas sampling tubes to anaesthetic and respiratory equipment麻醉和呼吸设备用气体取样管的连接
EN 13060:2004Small steam sterilizers小型蒸汽灭菌器
EN 13220:1998Flow-metering devices for connection to terminal units of medical gas pipeline systems医用燃气管道系统终端元件连接用流量计装置
EN 13328-1:2001Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance麻醉和呼吸用呼吸系统过滤器 第1部分：评估过滤性能的盐试验
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 13328-2:2002Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
EN 13328-2:2002/A1:2003麻醉和呼吸用呼吸系统过滤器.非过滤状态Note 3
EN ISO 13485:2003Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
EN ISO 13485:2003/AC:2007医疗设备.质量管理体系.管理要求EN ISO 13488:2000 EN ISO 13485:2000
EN 46003:1999
EN 13544-1:2007Respiratory therapy equipment - Part 1: Nebulizing systems and their components呼吸治疗设备.第1部分:雾化系统及其元部件EN 13544-1:2001
EN 13544-2:2002Respiratory therapy equipment - Part 2: Tubing and connectors呼吸治疗设备.管道和连接件
EN 13544-3:2001Respiratory therapy equipment - Part 3: Air entrainment devices呼吸疗法设备.第3部分:气体传输设备
EN 13624:2003Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)
EN 13718-1:2002Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care航空、水域和困难地形区域用救护车.连续救护患者用医疗器械接口要求
EN 13726-1:2002Test methods for primary wound dressings - Part 1: Aspects of absorbency主要伤口敷料试验方法.吸收度
EN 13726-2:2002Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings主要伤口敷料试验方法.可渗透薄膜敷料湿气蒸发传输率
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 13727:2003Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)化学消毒剂和防腐剂.医疗器械用化学消毒剂杀菌活性评价的定量悬浮试验.试验方法和要求(第2阶段/第1步)
EN 13795-1:2002Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products用作医疗用品的病人、医护人员和设备用外科窗帘、工作服和空气清新器.生产者、加工者和产品的一般要求
EN 13795-2:2004Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods作为医务用品的病人、医疗人员和医用设备用手术盖单、长外衣和无污染套装.第2部分:试验方法
EN 13795-3:2006Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels患者、医务人员和设备作为医疗器材使用的外科被单、睡衣、超净套装.第3部分:性能要求和性能水平
EN 13824:2004Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements医疗设备的灭菌.液体医疗设备的无菌操作.要求
EN 13826:2003Peak expiratory flow meters呼气峰值流量表
EN 13867:2002Concentrates for haemodialysis and related therapies血液透析和有关治疗用浓缩物
EN 13976-1:2003Rescue systems - Transportation of incubators - Part 1: Interface conditions营救系统.婴儿保温箱的运输.接口条件
EN 13976-2:2003Rescue systems - Transportation of incubators - Part 2: System requirements营救系统.婴儿保温箱的运输.系统要求
EN 14079:2003Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze非放射性的医疗装置.脱脂纱布、脱脂棉和脱胶纱布的性能要求和试验方法
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 14155-1:2003Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)人用医疗设备的临床调查.一般要求EN 540:1993
EN ISO 14155-2:2003Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)医学研究受验者用医疗器械的临床调查.临床调查计规划
EN ISO 14160:1998Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)包含有动物来源材料的一次性医用设备的消毒.液体化学消毒液消毒的确认和常规管理
EN 14180:2003Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验
EN 14299:2004Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents非活性外科植入物.心脏和血管植入物的特殊要求.动脉用斯滕特固定模的特殊要求
EN 14348:2005Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)化学消毒剂和防腐抗菌剂.评定包括仪器消毒剂在内的医用化学消毒剂灭分支杆菌活性用定量悬浮试验.试验方法和要求(阶段2,步骤1)
EN ISO 14408:2007Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)激光手术用设计的气管导管.标志和附带信息的要求
EN ISO 14534:2002Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)眼科光学.接触镜片和接触透镜保护制品.基础要求EN ISO 14534:1997
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 14561:2006Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)化学消毒剂和防腐剂.评估医学领域用器械灭菌作用的定量病媒试验.试验方法和要求(第2阶段，第2步).
EN 14562:2006Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)化学消毒剂和防腐剂.评估医学领域用器械灭真菌或酵母菌作用的定量病媒试验.试验方法和要求(第2阶段，第1步)
EN ISO 14602:1998Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)外科固定植入物.骨接合术植入物.特殊要求
EN ISO 14607:2007Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)外科植入物.乳房植入物的特殊要求
EN ISO 14630:2005Non-active surgical implants - General requirements (ISO 14630:2005)非活性外科植入物通用要求EN ISO 14630:1997
EN 14683:2005Surgical masks - Requirements and test methods外科手术面罩.要求和试验办法
EN ISO 14889:2003Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)眼科光学.眼镜镜片.未切精加工眼镜片的基本要求EN ISO 14889:1997
EN 14931:2006Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing病员用高压仓(PVHO).高压疗法用多位置高压室.性能、安全要求和试验
EN ISO 14937:2000Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)医疗保健产品灭菌消毒剂的特性及医疗装置消毒的开发、确认和程序控制的一般要求
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 14971:2007Medical devices - Application of risk management to medical devices (ISO 14971:2007)医疗器械 风险管理的应用EN ISO 14971:2000
EN ISO 15001:2004Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)麻醉和呼吸设备.与氧气的兼容性
EN ISO 15004-1:2006Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)眼科仪器基本要求和试验方法第1部分：适用于各类眼科仪器的一般要求EN ISO 15004:1997
EN ISO 15225:2000Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) EN ISO 15225:2000/A1:2004眼科仪器基本要求和试验方法第1部分：适用于各类眼科仪器的一般要求Note 3
EN 15424:2007Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices医疗设备灭菌.低温蒸汽和甲醛.医疗设备灭菌过程的制定、确认和常规控制的要求
EN ISO 15747:2005Plastics containers for intravenous injection (ISO 15747:2003)静脉注射用塑料容器
EN ISO 15883-1:2006Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)洗涤消毒器.第1部分:一般要求、术语、定义和试验.
EN ISO 15883-2:2006Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)\洗涤消毒器.对外科手术器具、麻醉器具、碗、碟、接收器、器具和玻璃器具等进行热消毒的洗涤消毒器的要求和试验
EN ISO 15883-3:2006Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)\洗涤消毒器.对人类废弃物容器进行热消毒的洗涤消毒器的要求和试验
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 16201:2006Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)用于残障人员的技术辅助设备日常生活用环境控制系统
EN ISO 17510-1:2002Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002)睡眠窒息呼吸治疗.第1部分:睡眠窒息呼吸治疗设备
EN ISO 17510-2:2003Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2003)睡眠窒息呼吸治疗.第2部分:面具和使用附件
EN ISO 17664:2004Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)医疗器械的消毒.生产商提供的可重复消毒医疗器械的处理信息
EN ISO 17665-1:2006Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)医疗保健产品灭菌.湿热.医疗器械灭菌过程技术革新、检验、日程控制的要求EN 554:1994
EN ISO 18777:2005Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)医用可移动的液氧装置.特殊要求
EN ISO 18778:2005Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)呼吸装置.婴儿监视器.特殊要求
EN ISO 18779:2005Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)储备氧气和氧气混合物的医疗设备.特殊要求
EN ISO 19054:2006Rail systems for supporting medical equipment (ISO 19054:2005) 支架式医用设备的导轨系统EN 12218:1998
EN 20594-1:1993Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
EN 20594-1:1993/A1:1997注射器、针头及其他医疗器械为6%（鲁尔）的锥形接头 第1部分：一般要求Note 3
EN ISO 21171:2006Medical gloves - Determination of removable surface powder (ISO 21171:2006)医疗专用手套.可移动表面粉末的测定
EN ISO 21534:2007Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)无源外科植入物关节置换植入物特殊要求EN 12010:1998
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 21535:2007Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)无源外科植入物关节置换植入物髋关节置换植入物的特殊要求EN 12563:1998
EN ISO 21536:2007Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)无源外科植入物关节置换植入物膝关节置换植入物的特殊要求EN 12564:1998
EN ISO 21647:2004Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004) EN ISO 21647:2004/AC:2006医疗电气设备.呼吸气监测器的基本安全和主要性能的特殊要求.EN 12598:1999
EN ISO 11196:1997
EN 864:1996
EN ISO 21649:2006Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)医用无针头式注射器.要求和试验方法
EN ISO 21969:2006High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)同医疗气体设备一起使用的高压挠性连接件EN 13221:2000
EN ISO 22523:2006External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)外肢假体和矫形外支架.要求和试验方法EN 12523:1999
EN ISO 22610:2006Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)病人和门诊医务人员作为医疗器械使用的外科用布帘、长袍工作服和套服.测定防潮湿细菌渗透的试验方法
EN ISO 22612:2005Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)传染介质防护服.防干微生物渗入的试验方法
EN ISO 22675:2006Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)假肢.脚踝器械和脚部件试验.要求和试验法
EN ISO 23747:2007Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)麻醉和呼吸设备.自然呼吸者肺功能评定用呼气峰值流量计EN 13826:2003
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 27740:1992Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
EN 27740:1992/A1:1997外科器械.可拆卸刀片的手术刀.装配尺寸Note 3
EN 46003:1999 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003 质量体系.医疗设备.EN ISO 9003实施的特殊要求
EN 60118-13:1997 Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:1997)电声学.助听器.电磁兼容性(EMC
EN 60118-13:2005 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004)电声学.助听器.电磁兼容性(EMCEN 60118-13:1997
Note 2.1
EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies (IEC 60522:1999)X射线管装置的永久滤波的测定
EN 60580:2000 Medical electrical equipment - Dose area product meters
(IEC 60580:2000)放射区域剂量计
EN 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988)
Amendment A1:1993 to EN 60601-1:1990(IEC 60601-1:1988/A1:1991)
Amendment A2:1995 to EN 60601-1:1990(IEC 60601-1:1988/A2:1995)
Amendment A13:1996 to EN 60601-1:1990医疗电气设备.安全的一般要求Note 3
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
(IEC 60601-1-1:2000)医用电气设备.安全性的一般要求.副标准.医用电气设备的安全要求EN 60601-1-1:1993
+ A1:1996
Note 2.1
EN 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2001)医疗电气设备 第1-2部分：对安全性的一般要求 电磁兼容性 要求和试验EN 60601-1-2:1993
Note 2.1
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-1-3:1994 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
(IEC 60601-1-3:1994)医疗电气设备 第1-3部分：对安全性的一般要求 对诊断用X射线设备辐射防护的一般要求
EN 60601-1-4:1996 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems(IEC 60601-1-4:1996)
Amendment A1:1999 to EN 60601-1-4:1996
(IEC 60601-1-4:1996/A1:1999)医院电气设备.安全的一般要求.副标准. 可编程的医院电气设备的一般要求Note 3
EN 60601-1-6:2004 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
(IEC 60601-1-6:2004)医疗电气设备 .第1-6部分：对安全性的一般要求 .附属标准:使用性
EN 60601-2-1:1998 Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
(IEC 60601-2-1:1998)Amendment A1:2002 to EN 60601-2-1:1998
(IEC 60601-2-1:1998/A1:2002)医用电气设备.1MeV到50MeV范围之内电子加速器安全的特殊要求Note 3
EN 60601-2-2:2000 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
(IEC 60601-2-2:1998)医疗电气设备 第2-2部分：对高频外科设备的特殊要求EN 60601-2-2:1993
Note 2.1
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-3:1993 Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment
(IEC 60601-2-3:1991)
Amendment A1:1998 to EN 60601-2-3:1993
(IEC 60601-2-3:1991/A1:1998)医疗电气设备.特殊要求.短波治疗设备规范Note 3
EN 60601-2-4:2003 Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002)医疗电气设备.第2-4部分：心脏除颤器安全的特殊要求
EN 60601-2-5:2000 Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000)医疗电气设备 第2-5部分：超声治疗设备安全性的特殊要求
EN 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
(IEC 60601-2-7:1998)医疗电气设备 第2-7部分：对诊断用X射线发生器的高压发生器安全性的特殊要求
EN 60601-2-8:1997 Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
(IEC 60601-2-8:1987)
Amendment A1:1997 to EN 60601-2-8:1997
(IEC 60601-2-8:1987/A1:1997)医疗电气设备 第2-8部分：对在10KV~1 MV范围内治疗用X射线设备的安全性的特殊要求Note 3
EN 60601-2-9:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
(IEC 60601-2-9:1996)医疗电气设备 第2-9部分：对放射治疗中使用的带电连接辐射探测器的病人接触剂量计安全性的特殊要求
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-10:2000 Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
(IEC 60601-2-10:1987)Amendment A1:2001 to EN 60601-2-10:2000
(IEC 60601-2-10:1987/A1:2001)医疗电气设备 第2-10部分：神经和肌肉刺激器安全性的特殊要求Note 3
EN 60601-2-11:1997 Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
(IEC 60601-2-11:1997)
Amendment A1:2004 to EN 60601-2-11:1997
(IEC 60601-2-11:1997/A1:2004)医疗电气设备 第2-11部分：对伽玛束治疗设备安全性的特殊要求Note 3
EN 60601-2-16:1998 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:1998)医疗电气设备 第2-16部分：对血液透析，血液透析过滤和血液过滤设备安全的特殊要求
EN 60601-2-17:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment
(IEC 60601-2-17:1989)Amendment A1:1996 to EN 60601-2-17:1996
(IEC 60601-2-17:1989/A1:1996)医疗电气设备 第2-17部分：对遥控自动驱动伽玛射线装载后设备安全性的特殊要求Note 3
EN 60601-2-17:2004 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
(IEC 60601-2-17:2004)医疗电气设备.安全的特殊要求.修正和补充的试验EN 60601-2-17:1996
and its amendment
Note 2.1
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-18:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
(IEC 60601-2-18:1996)
Amendment A1:2000 to EN 60601-2-18:1996
(IEC 60601-2-18:1996/A1:2000)医用电气设备.内窥镜设备安全的特殊要求Note 3
EN 60601-2-19:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators
(IEC 60601-2-19:1990)
Amendment A1:1996 to EN 60601-2-19:1996
(IEC 60601-2-19:1990/A1:1996)医疗电气设备 第2-19部分：对婴儿保育箱安全性的特殊要求Note 3
EN 60601-2-20:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of transport incubators (IEC 60601-2-20:1990
+ A1:1996)医疗电气设备 第2-20部分：对运输保育箱安全的特殊要求
EN 60601-2-21:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers
(IEC 60601-2-21:1994)
Amendment A1:1996 to EN 60601-2-21:1994
(IEC 60601-2-21:1994/A1:1996)医院电气设备.安全的特殊要求.婴幼儿辐射加热器规范Note 3
EN 60601-2-22:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
(IEC 60601-2-22:1995)医疗电气设备 第2-22部分：对诊断和治疗用激光设备安全性的特殊要求
EN 60601-2-23:2000 Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
(IEC 60601-2-23:1999)医疗电气设备 第2-23部分：对经皮分压强监视设备安全性的特殊要求EN 60601-2-23:1997
Note 2.1
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-24:1998 Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
(IEC 60601-2-24:1998)医疗电气设备.输液泵和控制器的特殊安全要求
EN 60601-2-25:1995 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
(IEC 60601-2-25:1993)
Amendment A1:1999 to EN 60601-2-25:1995
(IEC 60601-2-25:1993/A1:1999)医疗电气设备 第2-25部分：对心电图仪安全性的特殊要求Note 3
EN 60601-2-26:2003 Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
(IEC 60601-2-26:2002医用电气设备.脑电描记器安全的特殊要求EN 60601-2-26:1994
Note 2.1
EN 60601-2-27:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
(IEC 60601-2-27:1994)医疗电气设备 第2-27部分：对心电图描记监视设备安全性的特殊要求
EN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
(IEC 60601-2-27:2005)医用电气设备.第2部分第27节:心电描速器监视设备安全的特殊要求EN 60601-2-27:1994
Note 2.1
EN 60601-2-28:1993 Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
(IEC 60601-2-28:1993)医疗电气设备 第2-28部分：对医疗诊断用X射线源组件和X射线管组件安全性的特殊要求
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-29:1999 Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators
(IEC 60601-2-29:1999)医疗电气设备.安全的特殊要求.放射疗法模拟器安全的特殊要求EN 60601-2-29:1995
+ A1:1996
Note 2.1
EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
(IEC 60601-2-30:1999)医疗电气设备 第2-30部分：对自动循环血压间接监视设备安全性的特殊要求EN 60601-2-30:1995
Note 2.1
EN 60601-2-31:1995 Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
(IEC 60601-2-31:1994)
Amendment A1:1998 to EN 60601-2-31:1995
(IEC 60601-2-31:1994/A1:1998)医疗电器设备.安全的特殊要求.具有内部功率源的外部心脏起搏器Note 3
EN 60601-2-32:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
(IEC 60601-2-32:1994)医疗电气设备 第2-32部分：对X射线相关设备安全性的特殊要求
EN 60601-2-33:2002 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
(IEC 60601-2-33:2002)
Amendment A1:2005 to EN 60601-2-33:2002
(IEC 60601-2-33:2002/A1:2005)医用电气设备.安全特殊要求.医疗诊断用磁共振设备的特殊要求EN 60601-2-33:1995
+ A11:1997
Note 2.1 Note 3
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-34:2000 Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
(IEC 60601-2-34:2000)医疗电气设备 第2-34部分：对直接式血压监视设备安全性的特殊要求EN 60601-2-34:1995
Note 2.1
EN 60601-2-35:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
(IEC 60601-2-35:1996)医疗电气设备 第2-35部分：对医用保温毯、垫、床垫安全性的特殊要求
EN 60601-2-36:1997 Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
(IEC 60601-2-36:1997)医疗电气设备 第2-36部分：对体外诱发碎市术设备安全性的特殊要求
EN 60601-2-37:2001 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
(IEC 60601-2-37:2001)
Amendment A1:2005 to EN 60601-2-37:2001
(IEC 60601-2-37:2001/A1:2004)
Amendment A2:2005 to EN 60601-2-37:2001
(IEC 60601-2-37:2001/A2:2005)医疗电气设备.超声医疗诊断和监测设备安全的特殊要求Note 3
Note 3
EN 60601-2-38:1996 Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds
(IEC 60601-2-38:1996)
Amendment A1:2000 to EN 60601-2-38:1996
(IEC 60601-2-38:1996/A1:1999)医疗电器设备.安全的特殊要求.电动医院用床的安全特殊要求Note 3
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-39:1999 Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
(IEC 60601-2-39:1999医疗电气设备.安全的特殊要求.腹膜透析设备规范
EN 60601-2-40:1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
(IEC 60601-2-40:1998)医疗电气设备 第2-40部分:电子肌动描记器及诱发反应设备安全性的特殊要求
EN 60601-2-41:2000 Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
(IEC 60601-2-41:2000)医疗电气设备.外科手术灯和诊断用灯的安全特殊要求
EN 60601-2-43:2000 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures IEC 60601-2-43:2000 医用电气设备.安全的特殊要求.插入过程X射线设备的特殊安全要求
EN 60601-2-44:2001 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
(IEC 60601-2-44:2001)Amendment A1:2003 to EN 60601-2-44:2001
(IEC 60601-2-44:2001/A1:2002)医用电气设备.计算机断层摄影用X射线设备安全的特殊要求EN 60601-2-44:1999
Note 2.1 Note 3
EN 60601-2-45:2001 Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
(IEC 60601-2-45:2001)医疗电气设备.安全的特殊要求.乳腺X射线设备和定位装置安全性的特殊要求EN 60601-2-45:1998
Note 2.1
EN 60601-2-46:1998 Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables
(IEC 60601-2-46:1998)医用电气设备.安全的特殊要求.手术台规范
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-47:2001 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
(IEC 60601-2-47:2001)医用电气设备.特定安全要求.流动心电图测试系统的特定安全要求(包括基本性能)
EN 60601-2-49:2001Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
(IEC 60601-2-49:2001)医疗电气设备.多功能病人监测设备安全的特殊要求
EN 60601-2-50:2002Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
(IEC 60601-2-50:2000)医疗电气设备 第2-50部分:婴儿光治疗设备安全性的特殊要求
EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
(IEC 60601-2-51:2003)医疗电气设备.记录和分析单道和多道心电描记器的安全性特殊要求(包括主要性能)
EN 60627:2001 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
(IEC 60627:2001)诊断用X-射线成像设备 通用和大图形防散射滤栅的特性
EN 60645-1:2001 Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers
(IEC 60645-1:2001)电声学.声学设备.第1部分:纯音测听计EN 60645-1:1994
Note 2.1
EN 60645-2:1997 Audiometers - Part 2: Equipment for speech audiometry
(IEC 60645-2:1993)测听计.第2部分:语言测听装置
EN 60645-3:1995 Audiometers - Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes
(IEC 60645-3:1994)听力计.第3部分:声学和耳神经学用短持续试验信号
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60645-4:1995 Audiometers - Part 4: Equipment for extended high-frequency audiometry
(IEC 60645-4:1994)听力计.第4部分:高频声学设备
EN 61217:1996 Radiotherapy equipment - Coordinates, movements and scales
(IEC 61217:1996)Amendment A1:2001 to EN 61217:1996
(IEC 61217:1996/A1:2000)射治疗设备坐标系、运动和刻度Note 3
EN 61223-3-1:1999 Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems
(IEC 61223-3-1:1999)医院成像科的评定和常规试验.验收试验.辐射照相和辐射显微照相系统用X射线设备的成像性能
EN 61223-3-4:2000Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
(IEC 61223-3-4:2000)医疗图像部门常规试验和评定.验收试验.牙科X射线设备的图像性能
EN 61676:2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
(IEC 61676:2002)医用电气设备.在放射诊断中X射线管电压的无伤害性测量用剂量测定仪器
EN 62083:2001 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
(IEC 62083:2000)电气医疗设备.计划系统的放射处理安全性要求
EN 62220-1:2004 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
(IEC 62220-1:2003)医疗电气设备.数字X光成像设备特性.量子检测效率的确定
Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise
Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.
Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.
CENELECEN 60601-1:1990
Medical electrical equipment -- Part 1: General requirements for safety
IEC 60601-1:1988
[The referenced standard is EN 60601-1:1990]NONE
[There is no superseded standard]
Amendment A1:1993 to EN 60601-1:1990
IEC 60601-1:1988/A1:1991
[The referenced standard is EN 60601-1:1990
+A1:1993 to EN 60601-1:1990]Note 3
[The superseded standard is EN 60601-1:1990]
Amendment A2:1995 to EN 60601-1:1990
IEC 60601-1:1988/A2:1995
[The referenced standard is EN 60601-1:1990
+A1:1993 to EN 60601-1:1990
+A2:1995 to EN60601-1:1990]Note 3
[The superseded standard is EN 60601-1:1990
+ A1:1993]
Amendment A13:1996 to EN 60601-1:1990
[The referenced standard is EN 60601-1:1990
+ A1:1993 to EN 60601-1:1990
+ A2:1995 to EN 60601-1:1990
+ A13:1996 to EN 60601-1:1990]Note 3
[The superseded standard is EN 60601-1:1990
+ A1:1993
+ A2:1995]Date expired (01.07.1996)
2009-06-22
--------
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杨坤
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标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 285:2006Sterilization - Steam sterilizers - Large sterilizers消毒 蒸气消毒 大型消毒设备EN 285:1996
EN 375:2001Information supplied by the manufacturer with in vitro diagnostic reagents for professional use由生产商提供的专业用活体外诊断试剂的信息
EN 376:2002Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing生产者在实验室中用自检测诊断试剂提供信息
EN 455-1:2000Medical gloves for single use - Part 1: Requirements and testing for freedom from holes医疗专用手套.防洞要求和试验EN 455-1:1993
EN 455-2:2000Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996)医疗专用手套.物理性能要求和试验EN 455-2:1995
EN 455-3:2006Medical gloves for single use - Part 3: Requirements and testing for biological evaluation医疗专用手套.生物评价的要求和试验EN 455-3:1999
EN 556-1:2001Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-1:2001/AC:2006医疗设备的灭菌.拟被认定为无菌的医疗设备的要求.对最终灭菌设备的要求EN 556:1994 + A1:1998
EN 556-2:2003Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices医疗器械的消毒 标明为“消过毒”的医疗器械的要求 第2部分：消毒处理的医疗器械的要求
EN 591:2001Instructions for use for in vitro diagnostic instruments for professional use专用试管诊断仪的使用说明
EN 592:2002Instructions for use for in vitro diagnostic instruments for self-testing实验室条件下自测试诊断仪的使用说明
EN 737-1:1998Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum医疗气体管道系统.压缩医疗气体用终端设备和真空终端设备
EN 737-4:1998Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems医疗气体管道系统.麻醉气体净化系统的终端设备
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 738-4:1998Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment
EN 738-4:1998/A1:2002医用气体用压力调节器.医疗设备用低压压力调节器Note 3
EN 739:1998Low-pressure hose assemblies for use with medical gases
EN 739:1998/A1:2002医疗气体设备用低压软管组件Note 3
EN 740:1998Anaesthetic workstations and their modules - Particular requirements
EN 740:1998/A1:2004
EN 740:1998/AC:1998麻醉工作站及其工作舱特殊要求Note 3
EN 794-1:1997Lung ventilators - Part 1: Particular requirements for critical care ventilators
EN 794-1:1997/A1:2000肺呼吸器.临危看护呼吸器的特殊要求Note 3
EN 794-3:1998Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
EN 794-3:1998/A1:2005肺呼吸器.紧急情况和移动通风器的特殊要求Note 3
EN 980:2003Graphical symbols for use in the labelling of medical devices医疗器械标签用图形符号EN 980:1996
EN 1041:1998Information supplied by the manufacturer with medical devices医疗产品生产者提供的信息
EN 1060-1:1995Non-invasive sphygmomanometers - Part 1: General requirements
EN 1060-1:1995/A1:2002非侵入式血压计.第1部分:一般要求.修改件A1Note 3
EN 1060-2:1995Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers非侵入式血压表.第2部分:机械血压表的补充要求
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 1060-3:1997Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
EN 1060-3:1997/A1:2005非侵入式血压表.第3部分:电机血压表的补充要求Note 3
EN 1060-4:2004Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers非介入式血压计.第4部分:自动非介入式血压计整体系统精确度测定的试验过程
EN 1089-3:2004Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding可移动式气瓶.气瓶标识(不包括LPG).第3部分:色码EN 1089-3:1997
EN 1280-1:1997Agent specific filling systems for anaesthetic vaporizers - Part 1: Rectangular keyed filling systems
EN 1280-1:1997/A1:2000麻醉气化装置制剂特殊添充系统.拒形键控填充系统Note 3
EN 1281-2:1995Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified)麻醉和呼吸设备圆锥形接头第2部分：螺纹承重连接头
EN 1282-2:2005Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)气体切开插管.第2部分:儿科婴幼儿用管EN 1282-2:1997
EN 1422:1997Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods医用灭菌器.环氧乙烷灭菌器.要求和检验方法
EN 1618:1997Catheters other than intravascular catheters - Test methods for common properties=管内导管除外的其它导管.通用性能的测试法
EN 1639:2004Dentistry - Medical devices for dentistry - Instruments牙科学.牙科用医疗装置.器械EN 1639:1996
EN 1640:2004Dentistry - Medical devices for dentistry - Equipment牙科学.牙科用医疗装置.设备EN 1640:1996
EN 1641:2004Dentistry - Medical devices for dentistry - Materials牙科学.牙科用医疗装置.材料EN 1641:1996
EN 1642:2004Dentistry - Medical devices for dentistry - Dental implants牙科学.牙科用医疗装置.牙科植入物EN 1642:1996
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 1707:1996Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings注射器、针头和其它特定医疗器械用有6%(路厄)锥度的圆锥形配件.锁定配件
EN 1782:1998Tracheal tubes and connectors气管和连接件
EN 1820:2005Anaesthetic reservoir bags (ISO 5362:2000, modified)麻醉贮袋EN 1820:1997
EN 1865:1999Specifications for stretchers and other patient handling equipment used in road ambulances救护车里的担架和其他病人运送设备规范
EN 1970:2000Adjustable beds for disabled persons - Requirements and test methods
EN 1970:2000/A1:2005残疾人用可调整的床.要求和试验方法Note 3
EN 1985:1998Walking aids - General requirements and test methods助步器.一般要求和试验方法
EN ISO 4074:2002Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)天然胶乳橡胶避孕套--技术要求和试验方法EN 600:1996
EN ISO 4135:2001Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)麻醉和呼吸设备.词汇EN ISO 4135:1996
EN ISO 5356-1:2004Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)麻醉和呼吸设备.锥形接头.第1部分:锥体和锥套EN 1281-1:1997
EN ISO 5366-1:2004Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)麻醉和呼吸设备 气管造口插管 第1部分:成人用插管和接头EN 1282-1:1996
EN ISO 5840:2005Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)心血管植入物.心脏瓣膜修复术EN 12006-1:1999
EN ISO 7197:2006Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006)神经外科植入物一次性使用无菌脑积水分流管和组件
EN ISO 7376:2003Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)麻醉和呼吸设备.气管插管术用喉镜EN 1819:1997
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 7396-1:2007Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)医用气体管道系统第1部分：医用压缩气体和真空用管道系统EN 737-3:1998
EN ISO 7396-2:2007Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)医用气体管道系统第2部分：麻醉气体净化处理系统EN 737-2:1998
EN ISO 7439:2002Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002)含铜的宫内节育避孕器具.要求、试验
EN ISO 7886-3:2005Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)一次性使用无菌皮下注射器.第3部分:固定剂量免疫接种用自动报废注射器
ENISO 7886-4:2006Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)一次性使用无菌皮下注射器第4部分：具有预防特征重复使用的注射器
EN ISO 8185:1997Humidifiers for medical use - General requirements for humidification systems (ISO 8185:1997)医用增湿器.增湿系统的一般要求
EN ISO 8185:2007Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)医用增湿器.增湿系统的一般要求EN ISO 8185:1997
EN ISO 8359:1996Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)医疗电气设备.医用氧气浓缩器的安全要求
ENISO 8536-4:2007Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)医用输液设备.一次性使用重力输液式输液器
EN ISO 8835-2:2007Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)吸入式麻醉剂系统.第2部分:活性麻醉气体清除系统的传输和容纳系统EN 740:1998
EN ISO 8835-3:2007Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)吸入式麻醉剂系统.第3部分: 麻醉剂呼吸系统EN 740:1998
ENISO 8835-4:2004Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
EN ISO 8835-4:2004/AC:2006吸入式麻醉剂系统.麻醉剂蒸气输送设备
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 8835-5:2004Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)EN ISO 8835-5:2004/AC:2006吸入式麻醉剂系统. 麻醉剂通风设备
EN ISO 9360-1:2000Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)麻醉和呼吸设备.对人体呼吸气体进行加湿的热气和湿气交换器(HMEs).与最小潮量为250 ml的设备一起使用的热气和潮气交换器
EN ISO 9360-2:2002Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)麻醉和呼吸设备.使人体呼吸的气体变湿润用的热和潮气交换器(HMEs).气管造口病人用最小潮流量为250ml的热和潮气交换器
EN ISO 9713:2004Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)神经外科植入物.颅内动脉瘤自闭合夹
EN ISO 9919:2005Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求EN 865:1997
EN ISO 10079-1:1999Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)医用吸引设备.电驱动吸引设备.安全要求EN ISO 10079-1:1996
EN ISO 10079-2:1999Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)医疗吸引设备.手动吸引设备EN ISO 10079-2:1996
EN ISO 10079-3:1999Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)医疗吸引设备.真空或压力吸引设备EN ISO 10079-3:1996
EN ISO 10079-3:1999Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)医疗吸引设备.真空或压力吸引设备EN ISO 10079-3:1996
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 10328:2006Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)修复术.假腿的结构试验.要求和试验报告
EN ISO 10524-1:2006Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)医用气体设备用的压力调节器和带流量计的压力调节器EN 738-1:1997
EN ISO 10524-2:2006Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)与医疗气体共同使用的压力调节器.支管和输送管压力调节器EN 738-2:1998
EN ISO 10524-3:2006Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)医用气体压力调节器第3部分：气瓶阀压力调节器 EN 738-3:1998
EN ISO 10535:2006Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)残疾人用电梯.要求和试验方法EN ISO 10535:1998
EN ISO 10555-1:1996Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995)
EN ISO 10555-1:1996/A1:1999
EN ISO 10555-1:1996/A2:2004一次性使用、无菌管内导管.一般要求Note 3
EN ISO 10651-2:2004Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)医用肺通气机.基本安全和性能的特殊要求.通气机依赖型病人用家庭护理通气机EN 794-2:1997
EN ISO 10651-4:2002Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)肺换气机.对操作人员控制的复苏器的特殊要求
EN ISO 10651-6:2004Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)医用肺通气机.基本安全和性能的特殊要求.家庭保健通气机支撑装置
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 10993-1:2003Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)医疗器械的生物学评价 第1部分:评价和试验
EN ISO 10993-3:2003Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)医疗器械的生物学评价 第3部分:遗传毒性,致癌性毒性和生殖毒性试验EN 30993-3:1993
EN ISO 10993-4:2002Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002)
EN ISO 10993-4:2002/A1:2006医疗器械生物学评价 第4部分 血液交感的试验选择EN 30993-4:1993
Note 3
EN ISO 10993-5:1999Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)医疗器械的生物学评价 第5部分:体外细胞毒性试验EN 30993-5:1994
EN ISO 10993-6:2007Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)医疗器械的生物学评价 第6部分:植入后局部反应试验EN 30993-6:1994
EN ISO 10993-9:1999Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)医疗器械的生物学评价.第9部分:用于可降解产物识别与评定的结构
EN ISO 10993-10:2002Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)
EN ISO 10993-10:2002/A1:2006医疗器械生物学评价 第10部分:刺激与延迟型致敏试验EN ISO 10993-10:1995
Note 3皮肤刺激
眼刺激
皮内刺激
致敏
EN ISO 10993-11:2006Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)医疗器械的生物学评价 第11部分 全身毒性试验EN ISO 10993-11:1995急性全身毒性
热原
内毒素
EN ISO 10993-12:2004Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)医疗器械的生物评定.第12部分:样品制备和参考材料EN ISO 10993-12:1996
EN ISO 10993-13:1998Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)医学化合物的生物评定.第13部分:聚合医学化合物中降解物的质量和数量验证
EN ISO 10993-14:2001Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)医疗器械的生物评定.第14部分:陶瓷降解产品的识别与量化
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 10993-15:2000Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)医疗器械的生物评定.第15部分:金属及合金中降解产物的识别与量化
EN ISO 10993-16:1997Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)医疗器械的生物评定.第16部分:对退化产品和可滤清物的毒理动力学研究的方案和计算
EN ISO 10993-17:2002Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)医疗器械的生物评定.第17部分:可浸出物质容许限值的确定
EN ISO 10993-18:2005Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)医疗器械的生物评定.第18部分:材料的化学表征
EN ISO 11135-1:2007Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)医疗保健产品的灭菌环氧乙烷第1部分：医疗设备灭菌过程的研发、确认和常规控制的要求EN 550:1994
EN ISO 11137-1:2006Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)保健产品的灭菌.辐射.医疗器械消毒程序的建立、确认、和常规控制的要求EN 552:1994
EN ISO 11137-2:2007Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)医疗保健产品灭菌辐照第2部分：灭菌剂量的确定EN 552:1994
EN ISO 11138-2:2006Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)医疗保健产品灭菌生物指示物第2部分：环氧乙烷灭菌过程用生物指示物
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 11138-3:2006Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)医疗保健产品灭菌生物指示物第3部分：温热灭菌过程用生物指示物
EN ISO 11140-1:2005Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)保健产品的灭菌.化学指示剂.第1部分:一般要求EN 867-2:1997
EN ISO 11140-3:2007Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)医疗保健产品灭菌 化学指示物 第3部分:二级指示物 蒸气穿透试验纸EN 867-3:1997
EN ISO 11197:2004Medical supply units (ISO 11197:2004)医用供电装置EN 793:1997
EN ISO 11607-1:2006Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)终端无菌医学设备的包装.原材料、消毒阻挡系统和包装的要求
EN ISO 11607-2:2006Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)终端无菌医学设备的包装.组成、密封和装配过程的确认要求
EN ISO 11737-1:2006Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)医学器材的消毒.微生物学方法.产品上微生物群体的测定
EN ISO 11810-2:2007Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)激光以及与激光相关的设备 手术单和/或患者保护罩的耐激光性试验方法及分类 第2部分：二级点燃EN ISO 11810:2002
EN ISO 11979-8:2006Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006) 眼科植入物眼内透镜第8部分：基础要求EN 13503-8:2000
EN ISO 11990:2003Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)光学和光学仪器.激光和激光设备.气管柄激光抗性的测定EN ISO 11990:1999
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 12006-2:1998Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits非活性外科植入物.心脏和血管植入物的特殊要求.第2部分:人造血管包括心瓣血管接头,
EN 12006-3:1998Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices非活性外科植入物心脏和血管植入物的特殊要求第3部分：血管内植入物,
EN 12010:1998Non-active surgical implants - Joint replacement implants - Particular requirements非活性外科植入物关节替换植入物特殊要求
EN 12011:1998Instrumentation to be used in association with non-active surgical implants - General requirements使用上与非活性外科植入物有关的器具.一般要求
EN 12182:1999Technical aids for disabled persons - General requirements and test methods残疾人技术辅助器具.一般要求和试验方法.
EN 12322:1999In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
EN 12322:1999/A1:2001试管诊断医疗装置.微生物用培养基.培养的效能功率标准Note 3
EN 12342:1998Breathing tubes intended for use with anaesthetic apparatus and ventilators 用于麻醉器和人工呼吸器的呼吸器
EN 12442-1:2000Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk医疗设备生产专用动物产品及其衍生物.风险分析和管理
EN 12442-2:2000Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling医疗设备生产专用动物产品及其衍生物.来源控制、采集和处理
EN 12442-3:2000Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents医疗设备生产专用动物产品及其衍生物.病毒和传染性试剂消除和/或僵化的验证
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 12470-1:2000Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device体温计.第1部分:大刻度的玻璃内有金属液体的温度计
EN 12470-2:2000Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers临床温度计第2部分：相变型（点阵）温度计,
EN 12470-3:2000Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device\体温计.第3部分:大刻度的小型电测温度计的性能(可预测和不可预测的),
EN 12470-4:2000Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement临床温度计 第4部分：用于连续测量的电子温度计的性能
EN 12470-5:2003Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)体温计.第5部分:(大刻度的)耳蜗式红外测温计的性能
EN 12563:1998Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants稳定的外科植入物 关节替代植入物 髋关节替代植入物的特殊要求
EN 12564:1998Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants非有源外科植入物骨接合植入物特殊要求,
EN ISO 12870:2004Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)
EN ISO 12870:2004/AC:2005眼科光学.镜框.要求和试验方法EN ISO 12870:1997
EN 13014:2000Connections for gas sampling tubes to anaesthetic and respiratory equipment麻醉和呼吸设备用气体取样管的连接
EN 13060:2004Small steam sterilizers小型蒸汽灭菌器
EN 13220:1998Flow-metering devices for connection to terminal units of medical gas pipeline systems医用燃气管道系统终端元件连接用流量计装置
EN 13328-1:2001Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance麻醉和呼吸用呼吸系统过滤器 第1部分：评估过滤性能的盐试验
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 13328-2:2002Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
EN 13328-2:2002/A1:2003麻醉和呼吸用呼吸系统过滤器.非过滤状态Note 3
EN ISO 13485:2003Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
EN ISO 13485:2003/AC:2007医疗设备.质量管理体系.管理要求EN ISO 13488:2000 EN ISO 13485:2000
EN 46003:1999
EN 13544-1:2007Respiratory therapy equipment - Part 1: Nebulizing systems and their components呼吸治疗设备.第1部分:雾化系统及其元部件EN 13544-1:2001
EN 13544-2:2002Respiratory therapy equipment - Part 2: Tubing and connectors呼吸治疗设备.管道和连接件
EN 13544-3:2001Respiratory therapy equipment - Part 3: Air entrainment devices呼吸疗法设备.第3部分:气体传输设备
EN 13624:2003Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)
EN 13718-1:2002Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care航空、水域和困难地形区域用救护车.连续救护患者用医疗器械接口要求
EN 13726-1:2002Test methods for primary wound dressings - Part 1: Aspects of absorbency主要伤口敷料试验方法.吸收度
EN 13726-2:2002Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings主要伤口敷料试验方法.可渗透薄膜敷料湿气蒸发传输率
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 13727:2003Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)化学消毒剂和防腐剂.医疗器械用化学消毒剂杀菌活性评价的定量悬浮试验.试验方法和要求(第2阶段/第1步)
EN 13795-1:2002Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products用作医疗用品的病人、医护人员和设备用外科窗帘、工作服和空气清新器.生产者、加工者和产品的一般要求
EN 13795-2:2004Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods作为医务用品的病人、医疗人员和医用设备用手术盖单、长外衣和无污染套装.第2部分:试验方法
EN 13795-3:2006Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels患者、医务人员和设备作为医疗器材使用的外科被单、睡衣、超净套装.第3部分:性能要求和性能水平
EN 13824:2004Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements医疗设备的灭菌.液体医疗设备的无菌操作.要求
EN 13826:2003Peak expiratory flow meters呼气峰值流量表
EN 13867:2002Concentrates for haemodialysis and related therapies血液透析和有关治疗用浓缩物
EN 13976-1:2003Rescue systems - Transportation of incubators - Part 1: Interface conditions营救系统.婴儿保温箱的运输.接口条件
EN 13976-2:2003Rescue systems - Transportation of incubators - Part 2: System requirements营救系统.婴儿保温箱的运输.系统要求
EN 14079:2003Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze非放射性的医疗装置.脱脂纱布、脱脂棉和脱胶纱布的性能要求和试验方法
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 14155-1:2003Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)人用医疗设备的临床调查.一般要求EN 540:1993
EN ISO 14155-2:2003Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)医学研究受验者用医疗器械的临床调查.临床调查计规划
EN ISO 14160:1998Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)包含有动物来源材料的一次性医用设备的消毒.液体化学消毒液消毒的确认和常规管理
EN 14180:2003Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验
EN 14299:2004Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents非活性外科植入物.心脏和血管植入物的特殊要求.动脉用斯滕特固定模的特殊要求
EN 14348:2005Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)化学消毒剂和防腐抗菌剂.评定包括仪器消毒剂在内的医用化学消毒剂灭分支杆菌活性用定量悬浮试验.试验方法和要求(阶段2,步骤1)
EN ISO 14408:2007Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)激光手术用设计的气管导管.标志和附带信息的要求
EN ISO 14534:2002Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)眼科光学.接触镜片和接触透镜保护制品.基础要求EN ISO 14534:1997
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 14561:2006Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)化学消毒剂和防腐剂.评估医学领域用器械灭菌作用的定量病媒试验.试验方法和要求(第2阶段，第2步).
EN 14562:2006Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)化学消毒剂和防腐剂.评估医学领域用器械灭真菌或酵母菌作用的定量病媒试验.试验方法和要求(第2阶段，第1步)
EN ISO 14602:1998Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)外科固定植入物.骨接合术植入物.特殊要求
EN ISO 14607:2007Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)外科植入物.乳房植入物的特殊要求
EN ISO 14630:2005Non-active surgical implants - General requirements (ISO 14630:2005)非活性外科植入物通用要求EN ISO 14630:1997
EN 14683:2005Surgical masks - Requirements and test methods外科手术面罩.要求和试验办法
EN ISO 14889:2003Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)眼科光学.眼镜镜片.未切精加工眼镜片的基本要求EN ISO 14889:1997
EN 14931:2006Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing病员用高压仓(PVHO).高压疗法用多位置高压室.性能、安全要求和试验
EN ISO 14937:2000Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)医疗保健产品灭菌消毒剂的特性及医疗装置消毒的开发、确认和程序控制的一般要求
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 14971:2007Medical devices - Application of risk management to medical devices (ISO 14971:2007)医疗器械 风险管理的应用EN ISO 14971:2000
EN ISO 15001:2004Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)麻醉和呼吸设备.与氧气的兼容性
EN ISO 15004-1:2006Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)眼科仪器基本要求和试验方法第1部分：适用于各类眼科仪器的一般要求EN ISO 15004:1997
EN ISO 15225:2000Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) EN ISO 15225:2000/A1:2004眼科仪器基本要求和试验方法第1部分：适用于各类眼科仪器的一般要求Note 3
EN 15424:2007Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices医疗设备灭菌.低温蒸汽和甲醛.医疗设备灭菌过程的制定、确认和常规控制的要求
EN ISO 15747:2005Plastics containers for intravenous injection (ISO 15747:2003)静脉注射用塑料容器
EN ISO 15883-1:2006Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)洗涤消毒器.第1部分:一般要求、术语、定义和试验.
EN ISO 15883-2:2006Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)\洗涤消毒器.对外科手术器具、麻醉器具、碗、碟、接收器、器具和玻璃器具等进行热消毒的洗涤消毒器的要求和试验
EN ISO 15883-3:2006Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)\洗涤消毒器.对人类废弃物容器进行热消毒的洗涤消毒器的要求和试验
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 16201:2006Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)用于残障人员的技术辅助设备日常生活用环境控制系统
EN ISO 17510-1:2002Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002)睡眠窒息呼吸治疗.第1部分:睡眠窒息呼吸治疗设备
EN ISO 17510-2:2003Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2003)睡眠窒息呼吸治疗.第2部分:面具和使用附件
EN ISO 17664:2004Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)医疗器械的消毒.生产商提供的可重复消毒医疗器械的处理信息
EN ISO 17665-1:2006Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)医疗保健产品灭菌.湿热.医疗器械灭菌过程技术革新、检验、日程控制的要求EN 554:1994
EN ISO 18777:2005Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)医用可移动的液氧装置.特殊要求
EN ISO 18778:2005Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)呼吸装置.婴儿监视器.特殊要求
EN ISO 18779:2005Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)储备氧气和氧气混合物的医疗设备.特殊要求
EN ISO 19054:2006Rail systems for supporting medical equipment (ISO 19054:2005) 支架式医用设备的导轨系统EN 12218:1998
EN 20594-1:1993Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
EN 20594-1:1993/A1:1997注射器、针头及其他医疗器械为6%（鲁尔）的锥形接头 第1部分：一般要求Note 3
EN ISO 21171:2006Medical gloves - Determination of removable surface powder (ISO 21171:2006)医疗专用手套.可移动表面粉末的测定
EN ISO 21534:2007Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)无源外科植入物关节置换植入物特殊要求EN 12010:1998
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN ISO 21535:2007Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)无源外科植入物关节置换植入物髋关节置换植入物的特殊要求EN 12563:1998
EN ISO 21536:2007Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)无源外科植入物关节置换植入物膝关节置换植入物的特殊要求EN 12564:1998
EN ISO 21647:2004Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004) EN ISO 21647:2004/AC:2006医疗电气设备.呼吸气监测器的基本安全和主要性能的特殊要求.EN 12598:1999
EN ISO 11196:1997
EN 864:1996
EN ISO 21649:2006Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)医用无针头式注射器.要求和试验方法
EN ISO 21969:2006High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)同医疗气体设备一起使用的高压挠性连接件EN 13221:2000
EN ISO 22523:2006External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)外肢假体和矫形外支架.要求和试验方法EN 12523:1999
EN ISO 22610:2006Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)病人和门诊医务人员作为医疗器械使用的外科用布帘、长袍工作服和套服.测定防潮湿细菌渗透的试验方法
EN ISO 22612:2005Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)传染介质防护服.防干微生物渗入的试验方法
EN ISO 22675:2006Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)假肢.脚踝器械和脚部件试验.要求和试验法
EN ISO 23747:2007Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)麻醉和呼吸设备.自然呼吸者肺功能评定用呼气峰值流量计EN 13826:2003
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 27740:1992Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
EN 27740:1992/A1:1997外科器械.可拆卸刀片的手术刀.装配尺寸Note 3
EN 46003:1999 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003 质量体系.医疗设备.EN ISO 9003实施的特殊要求
EN 60118-13:1997 Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:1997)电声学.助听器.电磁兼容性(EMC
EN 60118-13:2005 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004)电声学.助听器.电磁兼容性(EMCEN 60118-13:1997
Note 2.1
EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies (IEC 60522:1999)X射线管装置的永久滤波的测定
EN 60580:2000 Medical electrical equipment - Dose area product meters
(IEC 60580:2000)放射区域剂量计
EN 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988)
Amendment A1:1993 to EN 60601-1:1990(IEC 60601-1:1988/A1:1991)
Amendment A2:1995 to EN 60601-1:1990(IEC 60601-1:1988/A2:1995)
Amendment A13:1996 to EN 60601-1:1990医疗电气设备.安全的一般要求Note 3
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
(IEC 60601-1-1:2000)医用电气设备.安全性的一般要求.副标准.医用电气设备的安全要求EN 60601-1-1:1993
+ A1:1996
Note 2.1
EN 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2001)医疗电气设备 第1-2部分：对安全性的一般要求 电磁兼容性 要求和试验EN 60601-1-2:1993
Note 2.1
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-1-3:1994 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
(IEC 60601-1-3:1994)医疗电气设备 第1-3部分：对安全性的一般要求 对诊断用X射线设备辐射防护的一般要求
EN 60601-1-4:1996 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems(IEC 60601-1-4:1996)
Amendment A1:1999 to EN 60601-1-4:1996
(IEC 60601-1-4:1996/A1:1999)医院电气设备.安全的一般要求.副标准. 可编程的医院电气设备的一般要求Note 3
EN 60601-1-6:2004 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
(IEC 60601-1-6:2004)医疗电气设备 .第1-6部分：对安全性的一般要求 .附属标准:使用性
EN 60601-2-1:1998 Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
(IEC 60601-2-1:1998)Amendment A1:2002 to EN 60601-2-1:1998
(IEC 60601-2-1:1998/A1:2002)医用电气设备.1MeV到50MeV范围之内电子加速器安全的特殊要求Note 3
EN 60601-2-2:2000 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
(IEC 60601-2-2:1998)医疗电气设备 第2-2部分：对高频外科设备的特殊要求EN 60601-2-2:1993
Note 2.1
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-3:1993 Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment
(IEC 60601-2-3:1991)
Amendment A1:1998 to EN 60601-2-3:1993
(IEC 60601-2-3:1991/A1:1998)医疗电气设备.特殊要求.短波治疗设备规范Note 3
EN 60601-2-4:2003 Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002)医疗电气设备.第2-4部分：心脏除颤器安全的特殊要求
EN 60601-2-5:2000 Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000)医疗电气设备 第2-5部分：超声治疗设备安全性的特殊要求
EN 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
(IEC 60601-2-7:1998)医疗电气设备 第2-7部分：对诊断用X射线发生器的高压发生器安全性的特殊要求
EN 60601-2-8:1997 Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
(IEC 60601-2-8:1987)
Amendment A1:1997 to EN 60601-2-8:1997
(IEC 60601-2-8:1987/A1:1997)医疗电气设备 第2-8部分：对在10KV~1 MV范围内治疗用X射线设备的安全性的特殊要求Note 3
EN 60601-2-9:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
(IEC 60601-2-9:1996)医疗电气设备 第2-9部分：对放射治疗中使用的带电连接辐射探测器的病人接触剂量计安全性的特殊要求
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-10:2000 Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
(IEC 60601-2-10:1987)Amendment A1:2001 to EN 60601-2-10:2000
(IEC 60601-2-10:1987/A1:2001)医疗电气设备 第2-10部分：神经和肌肉刺激器安全性的特殊要求Note 3
EN 60601-2-11:1997 Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
(IEC 60601-2-11:1997)
Amendment A1:2004 to EN 60601-2-11:1997
(IEC 60601-2-11:1997/A1:2004)医疗电气设备 第2-11部分：对伽玛束治疗设备安全性的特殊要求Note 3
EN 60601-2-16:1998 Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:1998)医疗电气设备 第2-16部分：对血液透析，血液透析过滤和血液过滤设备安全的特殊要求
EN 60601-2-17:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment
(IEC 60601-2-17:1989)Amendment A1:1996 to EN 60601-2-17:1996
(IEC 60601-2-17:1989/A1:1996)医疗电气设备 第2-17部分：对遥控自动驱动伽玛射线装载后设备安全性的特殊要求Note 3
EN 60601-2-17:2004 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
(IEC 60601-2-17:2004)医疗电气设备.安全的特殊要求.修正和补充的试验EN 60601-2-17:1996
and its amendment
Note 2.1
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-18:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
(IEC 60601-2-18:1996)
Amendment A1:2000 to EN 60601-2-18:1996
(IEC 60601-2-18:1996/A1:2000)医用电气设备.内窥镜设备安全的特殊要求Note 3
EN 60601-2-19:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators
(IEC 60601-2-19:1990)
Amendment A1:1996 to EN 60601-2-19:1996
(IEC 60601-2-19:1990/A1:1996)医疗电气设备 第2-19部分：对婴儿保育箱安全性的特殊要求Note 3
EN 60601-2-20:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of transport incubators (IEC 60601-2-20:1990
+ A1:1996)医疗电气设备 第2-20部分：对运输保育箱安全的特殊要求
EN 60601-2-21:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers
(IEC 60601-2-21:1994)
Amendment A1:1996 to EN 60601-2-21:1994
(IEC 60601-2-21:1994/A1:1996)医院电气设备.安全的特殊要求.婴幼儿辐射加热器规范Note 3
EN 60601-2-22:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
(IEC 60601-2-22:1995)医疗电气设备 第2-22部分：对诊断和治疗用激光设备安全性的特殊要求
EN 60601-2-23:2000 Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
(IEC 60601-2-23:1999)医疗电气设备 第2-23部分：对经皮分压强监视设备安全性的特殊要求EN 60601-2-23:1997
Note 2.1
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-24:1998 Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
(IEC 60601-2-24:1998)医疗电气设备.输液泵和控制器的特殊安全要求
EN 60601-2-25:1995 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
(IEC 60601-2-25:1993)
Amendment A1:1999 to EN 60601-2-25:1995
(IEC 60601-2-25:1993/A1:1999)医疗电气设备 第2-25部分：对心电图仪安全性的特殊要求Note 3
EN 60601-2-26:2003 Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
(IEC 60601-2-26:2002医用电气设备.脑电描记器安全的特殊要求EN 60601-2-26:1994
Note 2.1
EN 60601-2-27:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
(IEC 60601-2-27:1994)医疗电气设备 第2-27部分：对心电图描记监视设备安全性的特殊要求
EN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
(IEC 60601-2-27:2005)医用电气设备.第2部分第27节:心电描速器监视设备安全的特殊要求EN 60601-2-27:1994
Note 2.1
EN 60601-2-28:1993 Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
(IEC 60601-2-28:1993)医疗电气设备 第2-28部分：对医疗诊断用X射线源组件和X射线管组件安全性的特殊要求
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-29:1999 Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators
(IEC 60601-2-29:1999)医疗电气设备.安全的特殊要求.放射疗法模拟器安全的特殊要求EN 60601-2-29:1995
+ A1:1996
Note 2.1
EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
(IEC 60601-2-30:1999)医疗电气设备 第2-30部分：对自动循环血压间接监视设备安全性的特殊要求EN 60601-2-30:1995
Note 2.1
EN 60601-2-31:1995 Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
(IEC 60601-2-31:1994)
Amendment A1:1998 to EN 60601-2-31:1995
(IEC 60601-2-31:1994/A1:1998)医疗电器设备.安全的特殊要求.具有内部功率源的外部心脏起搏器Note 3
EN 60601-2-32:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
(IEC 60601-2-32:1994)医疗电气设备 第2-32部分：对X射线相关设备安全性的特殊要求
EN 60601-2-33:2002 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
(IEC 60601-2-33:2002)
Amendment A1:2005 to EN 60601-2-33:2002
(IEC 60601-2-33:2002/A1:2005)医用电气设备.安全特殊要求.医疗诊断用磁共振设备的特殊要求EN 60601-2-33:1995
+ A11:1997
Note 2.1 Note 3
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-34:2000 Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
(IEC 60601-2-34:2000)医疗电气设备 第2-34部分：对直接式血压监视设备安全性的特殊要求EN 60601-2-34:1995
Note 2.1
EN 60601-2-35:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
(IEC 60601-2-35:1996)医疗电气设备 第2-35部分：对医用保温毯、垫、床垫安全性的特殊要求
EN 60601-2-36:1997 Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
(IEC 60601-2-36:1997)医疗电气设备 第2-36部分：对体外诱发碎市术设备安全性的特殊要求
EN 60601-2-37:2001 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
(IEC 60601-2-37:2001)
Amendment A1:2005 to EN 60601-2-37:2001
(IEC 60601-2-37:2001/A1:2004)
Amendment A2:2005 to EN 60601-2-37:2001
(IEC 60601-2-37:2001/A2:2005)医疗电气设备.超声医疗诊断和监测设备安全的特殊要求Note 3
Note 3
EN 60601-2-38:1996 Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds
(IEC 60601-2-38:1996)
Amendment A1:2000 to EN 60601-2-38:1996
(IEC 60601-2-38:1996/A1:1999)医疗电器设备.安全的特殊要求.电动医院用床的安全特殊要求Note 3
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-39:1999 Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
(IEC 60601-2-39:1999医疗电气设备.安全的特殊要求.腹膜透析设备规范
EN 60601-2-40:1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
(IEC 60601-2-40:1998)医疗电气设备 第2-40部分:电子肌动描记器及诱发反应设备安全性的特殊要求
EN 60601-2-41:2000 Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
(IEC 60601-2-41:2000)医疗电气设备.外科手术灯和诊断用灯的安全特殊要求
EN 60601-2-43:2000 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures IEC 60601-2-43:2000 医用电气设备.安全的特殊要求.插入过程X射线设备的特殊安全要求
EN 60601-2-44:2001 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
(IEC 60601-2-44:2001)Amendment A1:2003 to EN 60601-2-44:2001
(IEC 60601-2-44:2001/A1:2002)医用电气设备.计算机断层摄影用X射线设备安全的特殊要求EN 60601-2-44:1999
Note 2.1 Note 3
EN 60601-2-45:2001 Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
(IEC 60601-2-45:2001)医疗电气设备.安全的特殊要求.乳腺X射线设备和定位装置安全性的特殊要求EN 60601-2-45:1998
Note 2.1
EN 60601-2-46:1998 Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables
(IEC 60601-2-46:1998)医用电气设备.安全的特殊要求.手术台规范
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60601-2-47:2001 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
(IEC 60601-2-47:2001)医用电气设备.特定安全要求.流动心电图测试系统的特定安全要求(包括基本性能)
EN 60601-2-49:2001Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
(IEC 60601-2-49:2001)医疗电气设备.多功能病人监测设备安全的特殊要求
EN 60601-2-50:2002Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
(IEC 60601-2-50:2000)医疗电气设备 第2-50部分:婴儿光治疗设备安全性的特殊要求
EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
(IEC 60601-2-51:2003)医疗电气设备.记录和分析单道和多道心电描记器的安全性特殊要求(包括主要性能)
EN 60627:2001 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
(IEC 60627:2001)诊断用X-射线成像设备 通用和大图形防散射滤栅的特性
EN 60645-1:2001 Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers
(IEC 60645-1:2001)电声学.声学设备.第1部分:纯音测听计EN 60645-1:1994
Note 2.1
EN 60645-2:1997 Audiometers - Part 2: Equipment for speech audiometry
(IEC 60645-2:1993)测听计.第2部分:语言测听装置
EN 60645-3:1995 Audiometers - Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes
(IEC 60645-3:1994)听力计.第3部分:声学和耳神经学用短持续试验信号
标准代号标准英文名称标准中文名称被替代的标准对应的国内标准
EN 60645-4:1995 Audiometers - Part 4: Equipment for extended high-frequency audiometry
(IEC 60645-4:1994)听力计.第4部分:高频声学设备
EN 61217:1996 Radiotherapy equipment - Coordinates, movements and scales
(IEC 61217:1996)Amendment A1:2001 to EN 61217:1996
(IEC 61217:1996/A1:2000)射治疗设备坐标系、运动和刻度Note 3
EN 61223-3-1:1999 Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems
(IEC 61223-3-1:1999)医院成像科的评定和常规试验.验收试验.辐射照相和辐射显微照相系统用X射线设备的成像性能
EN 61223-3-4:2000Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
(IEC 61223-3-4:2000)医疗图像部门常规试验和评定.验收试验.牙科X射线设备的图像性能
EN 61676:2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
(IEC 61676:2002)医用电气设备.在放射诊断中X射线管电压的无伤害性测量用剂量测定仪器
EN 62083:2001 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
(IEC 62083:2000)电气医疗设备.计划系统的放射处理安全性要求
EN 62220-1:2004 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
(IEC 62220-1:2003)医疗电气设备.数字X光成像设备特性.量子检测效率的确定
Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise
Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.
Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.
CENELECEN 60601-1:1990
Medical electrical equipment -- Part 1: General requirements for safety
IEC 60601-1:1988
[The referenced standard is EN 60601-1:1990]NONE
[There is no superseded standard]
Amendment A1:1993 to EN 60601-1:1990
IEC 60601-1:1988/A1:1991
[The referenced standard is EN 60601-1:1990
+A1:1993 to EN 60601-1:1990]Note 3
[The superseded standard is EN 60601-1:1990]
Amendment A2:1995 to EN 60601-1:1990
IEC 60601-1:1988/A2:1995
[The referenced standard is EN 60601-1:1990
+A1:1993 to EN 60601-1:1990
+A2:1995 to EN60601-1:1990]Note 3
[The superseded standard is EN 60601-1:1990
+ A1:1993]
Amendment A13:1996 to EN 60601-1:1990
[The referenced standard is EN 60601-1:1990
+ A1:1993 to EN 60601-1:1990
+ A2:1995 to EN 60601-1:1990
+ A13:1996 to EN 60601-1:1990]Note 3
[The superseded standard is EN 60601-1:1990
+ A1:1993
+ A2:1995]Date expired (01.07.1996)
2009-06-22
--------
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Eric Yang
杨坤
Project Manager
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