| 编号 | 中文名称 | 英文名称 |
|---|---|---|
| BIP 2071-2005 | 医疗器械:ISO 13485和ISO 9001 | Medical devices: ISO 13485 and ISO 9001 |
| BIP 3083-2009 | 医疗装置CD-ROM的标记用图形符号 | Graphical symbols for use in the labelling of medical devices CD-ROM |
| BS 2606-1955 | 峰值达150kV的医疗诊断用X射线防护手套规范 | Specification for X-ray protective gloves for medical diagnostic purposes up to 150 kV peak |
| BS 3043-1973 | 医疗放射照相已冲洗的X射线胶片的储存袋规范 | Specification for storage envelopes for processed X-ray films for medical radiography |
| BS 3970-2-1991 | 医疗制品灭菌消毒设备.第2部分:含水液体密封硬质容器用蒸汽消毒器规范 | Sterilizing and disinfecting equipment for medical products - Specification for steam sterilizers for aqueous fluids in sealed rigid containers |
| BS 3970-5-1990 | 医疗制品灭菌消毒设备.第5部分:低温蒸汽消毒器规范 | Sterilizing and disinfecting equipment for medical products - Specification for low temperature steam disinfectors |
| BS 4727-5 Group 01-1985 | 电工、电力、电信、电子学、照明和颜色术语.第5部分:医疗电气设备专用术语.第01集:辐射学和辐射物理学术语 | Glossary of electrotechnical, power, telecommunication, electronics, lighting and colour terms - Terms particular to electromedical equipment - Radiology and radiological physics terminology |
| BS 5682-1998 | 医疗用燃气管道系统探测头(快速连接器)规范 | Specification for probes (quick connectors) for use with medical gas pipeline systems |
| BS 6058-1989 | 医疗诊断用旋转阳极X射线管和X射线管组件的规定和检验方法 | Method of specifying and verifying the characteristics of rotating anode X-ray tubes and X-ray tube assemblies used in medical diagnosis |
| BS 7634-1993 | 医疗用气体管道系统用氧化浓缩器规范 | Specification for oxygen concentrators for use with medical gas pipeline systems |
| BS 7725-2.1-1994 | 医疗成像科评估和常规试验.第2部分:稳定性试验.第1节:洗片机方法 | Evaluation and routine testing in medical imaging departments - Constancy tests - Method for film processors |
| BS 7725-2.2-1994 | 医疗成像科评估和常规试验.第2部分:稳定性试验.第2节:屏蔽暗盒组件的X射线暗盒、换片器、胶片屏蔽触点和相 | Evaluation and routine testing in medical imaging departments - Constancy tests - Method for radiographic cassettes and film changers and film-screen contact and relative sensitivity of the screen-cassette assembly |
| BS 7725-2.3-1994 | 医疗成像科评估和常规试验.稳定性试验.暗室安全灯条件方法 | Evaluation and routine testing in medical imaging departments - Constancy tests - Method for darkroom safelight conditions |
| BS 8421-1-2003 | 医疗卫生信息学指南.健康护理的结果.传递给最终用户.通用指南和推荐规范 | Guide to health informatics - Results of healthcare service procedures - Delivery to end-users - General guidance and recommendations |
| BS 8441-2-2006 | 健康信息学.医疗数字成像轮廓.M-IHE6-4.8MIS-CT"CT存储的图像 | Health informatics - Medical digital imaging profiles - ?M-IHE6-4.8MIS-CT? CT images stored |
| BS 8480-2006 | 医疗装置.带电力驱动支持表面的椅子.要求 | Medical devices - Chairs with electrically operated support surfaces - Requirements |
| BS 8497-1-2008 | 遮掩和医疗设施用人类和动物防强光源的防目镜.产品规范 | Eyewear for protectionagainst intense lightsources used on humansand animals for cosmeticand medicalapplications –Part 1: Specification for products |
| BS 8497-2-2008 | 遮掩和医疗设施用人类和动物防强光源的防目镜.使用指南 | Eyewear for protectionagainst intense lightsources used on humansand animals forcosmetic and medicalapplicationsPart 2: Guidance on use |
| BS DD CEN/TS 14271-2003 | 医疗信息学.重要标记的文件交换格式 | Health informatics - File exchange format for vital signs |
| BS DD CEN/TS 14796-2004 | 医疗信息学.数据类型 | Health informatics - Data types |
| BS DD ENV 12018-1998 | 医疗保健使用的断续连接装置的识别、认可和公共门诊数据结构(包括可机读的卡） | Identification, administrative, and common clinical data structure for intermittently connected devices used in healthcare (including machine readable cards) |
| BS DD ENV 12443-2001 | 医疗信息.医疗保健信息框架(HIF) | Medical informatics - Healthcare information framework (HIF) |
| BS DD ENV 12537-1-1998 | 医疗信息学.医疗保健EDI 用信息客体登记.登记员 | Medical informatics - Registration of information objects used for EDI in healthcare - The register |
| BS DD ENV 12537-2-1998 | 医疗信息学.医疗保健 EDI用信息客体登记.医疗保健电子信息交换(EDI)使用的信息客体注册的程序 | Medical informatics - Registration of information objects used for EDI in healthcare - Procedures for the registration of information objects used in electronic data interchange (EDI) in healthcare |
| BS DD ENV 12538-1998 | 医疗信息学.患者诊疗安排和出院的信息 | Medical informatics - Messages for patient referral and discharge |
| BS DD ENV 12539-1998 | 医疗信息学.诊断业务部门的要求和报告文电 | Medical informatics - Request and report messages for diagnostic service departments |
| BS DD ENV 12610-1998 | 医疗信息学.医用产品标识 | Medical informatics - Medical product identification |
| BS DD ENV 12611-1998 | 医疗信息学.概念系统的编目结构.医疗装置 | Medical informatics - Categorical structure of systems of concepts - Medical devices |
| BS DD ENV 12612-1998 | 医疗信息学.医疗保健管理信息交换的文电 | Medical informatics - Messages for the exchange of healthcare administrative information |
| BS DD ENV 12924-1998 | 医疗信息学.医疗保健信息系统的安全性采编和保护 | Medical informatics - Security categorisation and protection for healthcare information systems |
| BS DD ENV 13607-2000 | 医疗保健信息学.医药处方信息交换用的电文 | Health informatics - Messages for the exchange of information on medicine prescriptions |
| BS DD ENV 13608-1-2000 | 医疗保健信息学.保健通信的安全性.概念和术语 | Health informatics - Security for healthcare communication - Concepts and terminology |
| BS DD ENV 13608-2-2000 | 医疗保健信息学.保健通信的安全性.安全数据对象 | Health informatics - Security for healthcare communication - Secure data objects |
| BS DD ENV 13608-3-2000 | 医疗保健信息学.保健通信的安全性.安全数据通道 | Health informatics - Security for healthcare communication - Secure data channels |
| BS DD ENV 13609-2-2000 | 医疗保健信息学.保健系统中支持信息的维护电文.医学实验室专用信息的更新 | Healthcare informatics - Messages for maintenance of supporting information in healthcare systems - Updating of medical laboratory-specific information |
| BS DD ENV 13729-2000 | 医疗卫生信息学.安全用户识别.强鉴别能力微处理机识别卡 | Health informatics - Secure user identification - Strong authentication microprocessor cards |
| BS DD ENV 13735-2001 | 医疗卫生信息.与病人连接的医疗装置的互操作性 | Health informatics - Interoperability of patient connected medical devices |
| BS DD ENV 1613-1996 | 医疗信息学.实验室信息交换的文电 | Medical informatics - Messages for exchange of laboratory information |
| BS DD ISO/TS 10993-19-2006 | 医疗设备的生物评定.材料的物理-化学、形态学和地形学特征 | Biological evaluation of medical devices - Physico-chemical, morphological and topographical characterization of materials |
| BS DD ISO/TS 10993-20-2006 | 医疗设备的生物评定.医疗设备的免疫毒物学试验的原则和方法 | Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices |
| BS DD ISO/TS 11073-92001-2007 | 健康信息学.医疗波形格式.编码规则 | Health informatics - Medical waveform format - Encoding rules |
| BS DD ISO/TS 18308-2004 | 医疗信息学.电子医疗记录结构要求 | Health informatics - Requirements for an electronic health record architecture |
| BS DD ISO/TS 19218-2005 | 医疗设备.不良反应的类型和起因的编码体系 | Medical devices - Coding structure for adverse event type and cause |
| BS DD ISO/TS 21667-2004 | 医疗健康信息学.健康指示器概念框架 | Health informatics - Health indicators conceptual framework |
| BS DD ISO/TS 22220-2009 | 健康信息.医疗保健主题的识别 | Health informatics - Identification of subjects of health care |
| BS EN 1041-1998 | 由厂商提供的医疗设备信息 | Information supplied by the manufacturer with medical devices |
| BS EN 1041-2008 | 医疗装置厂商提供的信息 | Information supplied by the manufacturer of medical devices |
| BS EN 12322-1999 | 体外诊断医疗装置.微生物培养基.培养基性能标准 | In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
| BS EN 12376-1999 | 体外诊断医疗装置.生物斑渍体外诊断剂发生器提供的信息 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| BS EN 12967-1-2007 | 医疗信息学.服务体系机构.企业观点 | Health informatics - Service architecture - Enterprise viewpoint |
| BS EN 12967-3-2007 | 医疗信息学.服务体系机构.计算观点 | Health informatics - Service architecture - Computational viewpoint |
| BS EN 13532-2002 | 自测试用的体外诊断医疗装置的一般要求 | General requirements for in vitro diagnostic medical devices for self-testing |
| BS EN 13609-1-2005 | 健康信息学.医疗保健系统支持信息维护用消息.编码方案的更新 | Health informatics - Messages for maintenance of supporting information in healthcare systems - Updating of coding schemes |
| BS EN 13612-2002 | 体外诊断医疗装置的性能评估 | Performance evaluation of in vitro diagnostic medical devices |
| BS EN 13624-2003 | 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) | Chemical 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) |
| BS EN 13718-1-2008 | 医疗车辆及其设备.空中救护机.用于空中救护机的医疗装置要求 | Medical vehicles and their equipment - Part 1:Air ambulances - Requirements for medical devices used in air ambulances |
| BS EN 13718-2-2008 | 医疗车辆及其设备.空中救护机.空中救护机的操作和技术要求 | Medical vehicles and their equipment - Part 2:Air ambulances - Operational and technical requirements of air ambulances |
| BS EN 13727-2003 | 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) | Chemical 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) |
| BS EN 13795-1-2002+A1-2009 | 用作医疗器械的患者,医护人员和医疗器械用覆盖巾,手术服和清洁空气套装.制造商,处理装置和产品的一般要求 | Surgical drapes, gownsand clean air suits, usedas medical devices, forpatients, clinical staffand equipment —Part 1: General requirements formanufacturers, processors andproducts |
| BS EN 13795-2-2004+A1-2009 | 用作医疗器械的患者,医护人员和医疗器械用覆盖巾,手术服和清洁空气套装.试验方法 | Surgical drapes, gownsand clean air suits, usedas medical devices forpatients, clinical staffand equipment —Part 2: Test methods |
| BS EN 13795-3-2006+A1-2009 | 用作医疗器械的患者,医护人员和医疗器械用覆盖巾,手术服和清洁空气套装.性能要求和性能等级 | Surgical drapes, gownsand clean air suits, usedas medical devices forpatients, clinical staffand equipment —Part 3: Performance requirements andperformance levels |
| BS EN 13824-2004 | 医疗设备的灭菌.液体医疗设备的无菌操作.要求 | Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements |
| BS EN 13975-2003 | 体外诊断用医疗装置的验收试验用取样规程.统计特性 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
| BS EN 14079-2003 | 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 | Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
| BS EN 14254-2004 | 体外诊断医疗设备.取自于人体的不包括血液的样品用一次性容器 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| BS EN 14463-2007 | 医学信息学.描述医疗分类系统内容的术语.分类标记语言(ClaML) | Health informatics - A syntax to represent the content of medical classification systems - ClaML |
| BS EN 14484-2004 | 医疗信息学.EU数据保护指令中包含的个人医疗数据的国际传送.高级安全政策 | Health informatics - International transfer of personal health data covered by the EU data protection directive - High level security policy |
| BS EN 14485-2004 | 医疗信息学.EU数据保护指令国际应用部分中的个人医疗数据的处理指南 | Health informatics - Guidance for handling personal health data in international applications in the context of the EU data protection directive |
| BS EN 14563-2008 | 化学消毒剂和防腐剂.医疗领域中器械用化学消毒剂的分枝杆菌或杀结核菌活性评估用定量带菌体试验.试验方法和 | Chemical disinfectants and antiseptics - Quantitative carrier testfor the evaluation of mycobactericidal or tuberculocidal activity ofchemical disinfectants used for instruments in the medical area -Test method and requirements (phase 2, step 2) |
| BS EN 15424-2007 | 医疗设备灭菌.低温蒸汽和甲醛灭菌器.医疗设备灭菌过程的制定、确认和常规控制的要求 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN 1639-2009 | 牙科学.牙科用医疗器械.仪器 | Dentistry - Medical devices for dentistry - Instruments |
| BS EN 1640-2009 | 牙科学.牙科用医疗器械.设备 | Dentistry - Medical devices for dentistry - Equipment |
| BS EN 1641-2009 | 牙科学.牙科用医疗器械.材料 | Dentistry - Medical devices for dentistry - Materials |
| BS EN 1642-2009 | 牙科学.牙科用医疗器械.牙科植入物 | Dentistry - Medical devices for dentistry - Dental implants |
| BS EN 1707-1997 | 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 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| BS EN 455-1-2000 | 一次性医疗用手套.无孔洞要求和试验 | Medical gloves for single use - Requirements and testing for freedom from holes |
| BS EN 455-2-2009 | 一次性医疗用手套.物理性能要求和试验 | Medical gloves for single use - Requirements and testing for physical properties |
| BS EN 455-3-2006 | 一次性医疗用手套.生物评价的要求和试验 | Medical gloves for single use — Part 3: Requirements and testing for biological evaluation |
| BS EN 45502-1-1998 | 活性可植入医疗装置.制造商提供的安全,标记和信息的一般要求 | Active implantable medical devices - General requirements for safety, marking and information to be provided by the manufacturer |
| BS EN 45502-2-1-2004 | 活性可植入医疗器件.用于治疗缓慢性心率失常的活性可植入医疗器件的特殊要求(心脏起搏器) | Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) |
| BS EN 45502-2-2-2008 | 有源可植入医疗器件.用于治疗缓慢性心率失常的活性可植入医疗器件的特殊要求(心脏起搏器) | Active implantable medical devices - Part 2-2:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) |
| BS EN 550-1994 | 医疗装置的杀菌.用环氧乙烷杀菌的验证和常规控制 | Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization |
| BS EN 55011-2007 | 工业、科学和医疗(ISM)射频设备.电磁干扰特征.极限值和测量方法 | Industrial, scientific and medical (ISM) radio-frequency Equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement |
| BS EN 55011-2009 | 工业、科学和医疗设备.射频干扰特性.限值和测量方法 | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| BS EN 556-1-2001 | 医疗设备的杀菌.拟定为无菌的医疗设备的要求.对最终杀菌设备的要求 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices |
| BS EN 556-2-2004 | 医疗器械的灭菌.拟被认定为无菌的医疗设备的要求.无菌处理的医疗设备的要求 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices |
| BS EN 60336-2005 | 医用电气设备.医疗诊断用X-射线管组件.焦点特性 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| BS EN 60406-1997 | X射线医疗诊断用X射线胶片暗盒和乳腺X射线胶片暗盒 | Specification for radiographic cassettes and mammographic cassettes used for medical X-ray diagnosis |
| BS EN 60598-2-25-1995 | 灯具.第2部分:专门要求.第25节:医院和医疗保健中心临床用灯具 | Luminaires - Part 2.25: Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings |
| BS EN 60601-1-2006 | 医疗电气设备.基本安全和基本性能的一般要求 | Medical electrical equipment - General requirements for basic safety and essential performance |
| BS EN 60601-1-3-2008 | 医疗电气设备.基本安全和重要性能的通用要求.附属标准.X射线诊断设备的辐射防护 | Medical electrical equipment -Part 1-3: General requirements for basic safety and essential performance - Collateral Standard - Radiation protection in diagnostic X-ray equipment |
| BS EN 60601-1-8-2004 | 医疗电气设备.安全的一般要求.并列标准.医疗电气设备和医疗电气系统中警报系统的一般要求、试验和指南 | Medical electrical equipment - General requirements for safety - Collateral standard - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| BS EN 60601-1-8-2007 | 医用电气设备.基本安全和基本性能的通用要求.间接标准:医疗电气设备和医疗电气系统中警报系统的一般要求、 | Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| BS EN 60601-1-9-2008 | 医疗设备综合.基本安全和基本性能的通用要求.间接标准.环保意识的设计的要求 | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard - Requirements for environmentally conscious design |
| BS EN 60601-2-12-2006 | 医疗电气设备.第2-12部分:肺呼吸机安全性的特殊要求.危急护理呼吸机 | Medical electrical equipment - Particular requirements for the safety of lung ventilators - Critical care ventilators |
| BS EN 60601-2-17-2004 | 医疗电气设备.自动控制短距离放射治疗后装设备安全的特殊要求 | Medical electrical equipment - Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
| BS EN 60601-2-19-2009 | 医疗电气设备.婴儿保温箱基本安全和主要性能的特殊要求 | Medical electrical equipment - Part 2-19:Particular requirements for the basic safety and essential performance of infant incubators |
| BS EN 60601-2-22-1996 | 医疗电气设备.安全专门要求.激光诊断和治疗设备规范 | Medical electrical equipment - Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment |
| BS EN 60601-2-23-2000 | 医疗电气设备.经皮分压监测设备的安全性用特殊要求(包括基本性能) | Medical electrical equipment - Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment |
| BS EN 60601-2-24-1998 | 医疗电气设备.特殊安全要求.输液泵和控制器的特殊安全要求. | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of infusion pumps and controllers |
| BS EN 60601-2-25-1996 | 医疗电气设备.安全的特殊要求.心电图仪 | Medical electrical equipment - Particular requirements for safety - Specification for electrocardiographs |
| BS EN 60601-2-27-2006 | 医疗电气设备.第2-27部分:心电图监测设备的安全(包括基本性能)特殊要求 | Medical electricalequipment —Part 2-27: Particular requirements forthe safety, including essentialperformance, of electrocardiographicmonitoring equipment |
| BS EN 60601-2-29-2008 | 医疗电气设备.放射线疗法模拟器基本安全和重要性能的特殊要求 | Medical electrical equipment —Part 2-29: Particular requirements for the basic safetyand essential performance of radiotherapy simulators |
| BS EN 60601-2-3-1993 | 医疗电气设备.特殊安全要求.短波治疗设备规范 | Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment |
| BS EN 60601-2-33-2002+A2-2008 | 医用电气设备.第2-33部分:医疗诊断用磁共振设备的安全性特殊要求 | Medical electrical equipment -Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis |
| BS EN 60601-2-34-2001 | 医疗电气设备.安全性用特殊要求.直接血压监护设备安全性用特殊要求(包括基本性能) | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment |
| BS EN 60601-2-37-2001 | 医用电气设备.第2-37部分:超声波医疗诊断和监测设备的特殊安全要求 | Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment |
| BS EN 60601-2-37-2008 | 医疗电气设备.超声波医疗诊断和监测设备基本安全和重要性能的特殊要求 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| BS EN 60601-2-39-2008 | 医疗电气设备.腹膜透析设备的基本安全和重要性能的特殊要求 | Medical electrical equipment —Part 2-39: Particular requirements for basic safety andessential performance of peritoneal dialysisequipment |
| BS EN 60601-2-4-2003 | 医疗电气设备.安全的特殊要求.心脏去纤颤器的特殊安全要求 | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of cardiac defibrillators |
| BS EN 60601-2-40-1998 | 医疗电气设备.特殊安全要求.筋骨电流计和诱发反应设备规范 | Medical electrical equipment - Particular requirements for safety - Specification for electromyographs and evoked response equipment |
| BS EN 60601-2-41-2009 | 医疗电气设备.外科手术灯和诊断用灯基本安全性和本质性能的特殊要求 | Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
| BS EN 60601-2-43-2001 | 医疗电气设备.安全性用特殊要求.介入过程用X射线设备安全性用专用要求 | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of X-ray equipment for interventional procedures |
| BS EN 60601-2-49-2001 | 医疗用电气设备.多功能病人监测设备安全的专门要求 | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of multifunction patient monitoring equipment |
| BS EN 60601-2-50-2002 | 医疗用电气设备.安全性的特殊要求.婴幼儿光线治疗设备的安全性特殊要求 | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of infant phototherapy equipment |
| BS EN 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) | Medical electrical equipment - Particular requirements for safety - Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| BS EN 60806-2004 | 医疗诊断用旋转阳极X射线管最大对称辐射场强度测定 | Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis |
| BS EN 60976-2007 | 医疗电气设备.医疗电子加速器.功能的特性特征 | Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| BS EN 61010-2-040-2005 | 测量、控制和实验室用电气设备的安全要求.第2-040部分:医疗材料处理用灭菌器和清洗消毒器的特殊要求 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| BS EN 61010-2-101-2002 | 测量、控制和实验室用电气设备的安全要求.实验室诊断(IVD)医疗设备的特殊要求 | Safety requirements for electrical equipment for measurement, control and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment |
| BS EN 61157-2007 | 医疗诊断超声波设备声输出的报告用标准方法 | Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
| BS EN 61223-3-1-1999 | 医疗成像部门的评定及常规试验.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 | Evaluation and routine testing in medical imaging departments - Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems |
| BS EN 61223-3-4-2000 | 医疗成像部门的评定及常规试验.验收试验.牙科X射线设备成像性能 | Evaluation and routine testing in medical imaging departments - Acceptance tests |
| BS EN 61223-3-5-2004 | 医疗成像部门的评价及常规试验.验收试验.计算机断层摄影X射线设备的成像性能 | Evaluation and routine testing in medical imaging departments - Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| BS EN 61262-1-1995 | 医疗电气设备用光电X射线图象增强器的特性.第1部分:入口视场尺寸的测定 | Characteristics of electro-optical X-ray image intensifiers for medical electrical equipment - Determination of the entrance field size |
| BS EN 61262-2-1995 | 医疗电气设备用光电X射线图像增强器的特性.换算系数的测定 | Characteristics of electro-optical X-ray image intensifiers for medical electrical equipment - Determination of the conversion factor |
| BS EN 61262-5-1995 | 医疗电气设备用光电X射线图象增强器的特性.检测量子效率的测定 | Characteristics of electro-optical X-ray image intensifiers for medical electrical equipment - Determination of the detective quantum efficiency |
| BS EN 61326-2-6-2006 | 测量、控制和实验室用电气设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断(IVD)医疗设备 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Particular requirements - In vitro diagnostic (IVD) medical equipment |
| BS EN 61331-1-1995 | 医疗诊断时防X射线辐射的防护器具.材料的衰减性能的测定 | Protective devices against diagnostic medical X-radiation - Determination of attenuation properties of materials |
| BS EN 61331-2-1995 | 医疗诊断时防X射线辐射的防护器具.防护玻璃板 | Protective devices against diagnostic medical X-radiation - Protective glass plates |
| BS EN 61331-3-1999 | X射线医疗诊断保护装置.生殖腺防护装置和防护服装 | Protective devices against diagnostic medical X-radiation - Protective clothing and protective devices for gonads |
| BS EN 61676-2002+A1-2009 | 医疗电气设备.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 | Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology |
| BS EN 62127-1-2007 | 超声学.水听器.第1部分:医疗超声波场频率小于40MHz的测量和特性 | Ultrasonics —Hydrophones —Part 1: Measurement andcharacterization of medical ultrasonicfields up to 40 MHz |
| BS EN 62220-1-2004 | 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 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Determination of the detective quantum efficiency |
| BS EN 62220-1-3-2008 | 医疗电气设备.数字X射线成像装置的特性.探测量子效率的测定.动态成像用探测器 | Medical electrical equipment —Characteristics of digital X-rayimaging devices —Part 1-3: Determination of the detective quantumefficiency — Detectors used in dynamic imaging |
| BS EN 62274-2005 | 医疗电气设备.放射疗法记录和检验系统的安全 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| BS EN 62304-2006 | 医疗器械软件.软件使用周期过程 | Medical device software - Software life-cycle processes |
| BS EN 62353-2008 | 医疗电气设备.医疗电气设备的循环试验和维修后试验 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| BS EN 62359-2005 | 超声波学.场特征.医疗诊断超声场相关热和机械指数测定的试验方法 | Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| BS EN 62366-2008 | 医疗设备.医疗设备可用性工程的应用 | Medical devices - Application of usability engineering to medical devices |
| BS EN 62464-1-2007 | 医疗成象磁共振设备.实际成象质量参数测定 | Magnetic resonance equipment for medical imaging - Determination of essential image quality parameters |
| BS EN 62494-1-2008 | 医疗电气设备.数字X射线成像系统用曝光指数.一般X射线照相术用定义和要求 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Definitions and requirements for general radiography |
| BS EN 80601-2-35-2009 | 医疗电气设备.应用于加热的毛毯,衬垫或床垫及医用加热装置基本安全及基本性能的特殊规范 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| BS EN 80601-2-58-2009 | 医疗电气设备.眼科手术用晶状体移除装置和玻璃体切除装置基本安全和基本性能的特殊要求 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| BS EN 868-10-2009 | 灭菌医疗装置的包装.聚烯烃粘性涂覆非织物材料.要求和测试方法 | Packaging for terminally sterilized medical devices - Adhesive coated nonwoven materials of polyolefines - Requirements and test methods |
| BS EN 868-2-2009 | 灭菌医疗装置的包装.灭菌套要求和测试方法 | Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods |
| BS EN 868-3-2009 | 灭菌医疗装置的包装.生产纸袋(EN 868-4规定)和生产盒和卷筒用纸(EN 868-5规定)要求和试验方法 | Packaging for terminally sterilized medical devices - Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods |
| BS EN 868-4-2009 | 灭菌医疗装置的包装.纸袋要求和测试方法 | Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods |
| BS EN 868-5-2009 | 灭菌医疗装置的包装.多孔和塑料薄膜结构的密封袋和卷轴.要求和测试方法 | Packaging for terminally sterilized medical devices - Sealable pouches and reels of porous and plastic film construction - Requirements and test methods |
| BS EN 868-6-2009 | 灭菌医疗装置的包装.低温灭菌处理用纸.要求和测试方法 | Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods |
| BS EN 868-7-2009 | 灭菌医疗装置的包装.低温消毒处理用粘合铜版纸.要求和测试方法 | Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes - Requirements and test methods |
| BS EN 868-8-2009 | 灭菌医疗装置的包装.符合EN 285标准的蒸汽灭菌器用再用灭菌容器.要求和测试方法 | Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods |
| BS EN 868-9-2009 | 灭菌医疗装置的包装.第9部分:聚烯烃非包覆非织物材料.要求和测试方法 | Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods |
| BS EN 980-2008 | 医疗器械标签用图形符号 | Symbols for use in the labelling of medical devices |
| BS EN ISO 10079-1-2009 | 医疗吸引设备.第1部分:电动吸引设备安全要求(ISO 10079-1:1999) | Medical suctionequipmentPart 1: Electrically powered suctionequipment — Safety requirements (ISO10079-1:1999) |
| BS EN ISO 10079-3-2009 | 医疗吸引设备.第3部分:真空或用压力驱动的吸引设备(ISO 10079-3:1999) | Medical suctionequipmentPart 3: Suction equipment poweredfrom a vacuum or pressure source (ISO10079-3:1999) |
| BS EN ISO 10524-4-2008 | 医疗气体用压力调节器.低压调节器 | Pressure regulators for use with medical gases - Low-pressure regulators |
| BS EN ISO 10993-10-2009 | 医疗装置的生物学评估.刺激和迟延型超敏性试验 | Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity |
| BS EN ISO 10993-11-2009 | 医疗器械的生物学评价.全身毒性试验 | Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006) |
| BS EN ISO 10993-12-2009 | 医疗器械的生物评定.样品制备和标样 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) |
| BS EN ISO 10993-13-2009 | 医疗器械的生物学评价.陶瓷降解产物的识别和定量 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) |
| BS EN ISO 10993-14-2009 | 医疗器械的生物学评价.陶瓷降解产物的识别和定量 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| BS EN ISO 10993-15-2009 | 医疗器械的生物评定.金属与合金降解产物的识别与定性 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradationproducts from metals and alloys (ISO 10993-15:2000) |
| BS EN ISO 10993-16-2010 | 医疗器械的生物学评定.降解产物和可滤取物的毒物动力学研究设计 | Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables |
| BS EN ISO 10993-17-2009 | 医疗器械的生物学评价.浸出物允许限量的确定 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| BS EN ISO 10993-18-2009 | 医疗器械的生物学评价.材料的化学表征 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| BS EN ISO 10993-2-2006 | 医疗器械的生物评定.动物保护要求 | Biological evaluation of medical devices - Animal welfare requirements |
| BS EN ISO 10993-3-2009 | 医疗器械的生物学评价.遗传毒性,致癌性和生殖毒性试验 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) |
| BS EN ISO 10993-4-2009 | 医疗器械的生物评估.与血液相互作用的试验选择 | Biological evaluation of medical devices - Selection of tests for interactions with blood |
| BS EN ISO 10993-5-2009 | 医疗器械生物学评价.细胞毒性体外试验法 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| BS EN ISO 10993-6-2009 | 医疗器械的生物学评价.植入后的局部效应试验 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
| BS EN ISO 10993-7-2008 | 医疗器械的生物学评估.环氧乙烷灭菌残留量 | Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals |
| BS EN ISO 11073-10101-2006 | 健康信息学.床旁检测医疗设备通信.术语 | Health informatics - Point-of-care medical device communications - Nomenclature |
| BS EN ISO 11073-10201-2006 | 健康信息学.床旁检测医疗设备通信.传输轮廓.域信息模式 | Health informatics - Point-of-care medical device communication - Domain information model |
| BS EN ISO 11073-20101-2005 | 健康信息学.床旁检测医疗设备通信.应用轮廓.基本标准 | Health informatics - Point-of-care medical device communication - Application profiles - Base standard |
| BS EN ISO 11073-30200-2006 | 健康信息学.床旁检测医疗设备通信.传输轮廓.连接电缆 | Health informatics - Point-of-care medical device communication - Transport profile - Cable connected |
| BS EN ISO 11073-30300-2006 | 健康信息学.床旁检测医疗设备通信.传输轮廓.红外无线 | Health informatics - Point-of-care medical device communication - Transport profile - Infrared wireless |
| BS EN ISO 11135-1-2007 | 卫生保健品灭菌.环氧乙烷.医疗设备灭菌过程的制定、确认和常规控制的要求 | Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN 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 | Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 11138-1-2006 | 医疗保健产品灭菌.生物指示物.一般要求 | Sterilization of health care products - Biological indicators - General requirements |
| BS EN ISO 11138-2-2009 | 医疗保健产品灭菌.生物指示剂.环氧乙烷灭菌用生物指示剂 | Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes |
| BS EN ISO 11138-3-2009 | 医疗保健产品灭菌.生物指示物.湿热灭菌处理用生物指示剂 | Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes |
| BS EN ISO 11138-4-2006 | 医疗保健产品灭菌.生物指示物.干热灭菌用生物指示剂 | Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes |
| BS EN ISO 11138-5-2006 | 医疗保健产品灭菌.生物指示物.低温蒸汽和甲醛灭菌用生物指示剂 | Sterilization of health care products - Biological indicators - Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| BS EN ISO 11737-2-2009 | 医疗器械的消毒.微生物学法.灭菌过程的定义、有效性和维护中进行的无菌试验 | Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| BS EN ISO 13485-2003 | 医疗设备.质量管理体系.管理要求 | Medical devices - Quality management systems - Requirements for regulatory purposes |
| BS EN ISO 13606-5-2010 | 医疗信息学.电子健康记录通信.接口规范 | Health informatics - Electronic health record communication - Interface specification |
| BS EN ISO 14155-1-2009 | 人用医疗设备的临床调查.一般要求 | Clinical investigation of medical devices for human subjects - General requirements |
| BS EN ISO 14155-2-2009 | 医学研究受验者用医疗器械的临床调查.临床调查计规划 | Clinical investigation of medical devices for human subjects - Clinical investigation plans |
| BS EN ISO 14161-2009 | 医疗保健产品的灭菌.生物指示器.选择、使用和检验结果解释用指南 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
| BS EN ISO 14937-2009 | 保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发、验证及常规控制的一般要求 | Sterilization 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 |
| BS EN ISO 14971-2009 | 医疗器械.医疗器械风险管理的应用 | Medical devices - Application of risk management to medical devices |
| BS EN ISO 15002-2008 | 医疗气体管道系统连接到终端装置用流量测量装置 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| BS EN ISO 15193-2009 | 体外诊断医疗器械.生物源样品的数量测量.参考测量程序的内容和表示要求 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures |
| BS EN ISO 15194-2009 | 体外诊断医疗器械.生物源样品的数量测量.证明文件的认证参考材料和内容要求 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation |
| BS EN ISO 15225-2010 | 医疗器械.质量管理.医疗器械命名资料结构 | Medical devices - Quality management - Medical device nomenclature data structure |
| BS EN ISO 17664-2004 | 医疗器械的消毒.生产商提供的可再消毒医疗器械的处理信息 | Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices |
| BS EN 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 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 18104-2004 | 医疗信息学.护理用参考术语模式的综合 | Health informatics - Integration of a reference terminology model for nursing |
| BS EN ISO 18113-1-2009 | 体外诊断医疗器械.制造商提供的信息(标签).术语、定义和一般要求 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements |
| BS EN ISO 18113-2-2009 | 体外诊断医疗器械.制造商提供的信息(标签).专业用途的体外诊断试剂 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for professional use |
| BS EN ISO 18113-3-2009 | 体外诊断医疗器械.制造商提供的信息(标签).专业用体外诊断仪器 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for professional use |
| BS EN ISO 18113-4-2009 | 体外诊断医疗器械.制造商提供的信息(标签).自测用体外诊断剂 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing |
| BS EN ISO 18113-5-2009 | 体外诊断医疗器械.制造商提供的信息(标签).自试验用体外诊断仪器 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for self-testing |
| BS EN ISO 18779-2005 | 储备氧气和氧气混合物的医疗设备.特殊要求 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements |
| BS EN ISO 18812-2003 | 医疗信息学.医用分析仪与实验室信息系统的接口.使用说明文件 | Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles |
| BS EN ISO 21171-2006 | 医疗专用手套.可移动表面粉末的测定 | Medical gloves - Determination of removable surface powder |
| BS EN ISO 21549-1-2004 | 医疗信息学.病人医疗卡数据.通用结构 | Health informatics - Patient healthcard data - General structure |
| BS EN ISO 21549-2-2004 | 医疗信息学.病人医疗卡数据.共同对象 | Health informatics - Patient healthcard data - Common objects |
| BS EN ISO 21549-3-2004 | 医疗信息学.病人医疗卡数据.有限的临床数据 | Health informatics - Patient healthcard data - Limited clinical data |
| BS EN ISO 21549-5-2008 | 医疗信息学.病人医疗卡数据.鉴定数据 | Health informatics - Patient healthcard data - Identification data |
| BS EN ISO 21549-6-2008 | 医疗信息学.病人医疗卡数据.管理数据 | Health informatics - Patient healthcard data - Administrative data |
| BS EN ISO 21969-2009 | 同医疗气体设备一起使用的高压挠性连接件 | High-pressure flexible connections for use with medical gas systems |
| BS EN ISO 22442-1-2008 | 医疗设备用动物组织及其衍生物.风险管理的应用 | Medical devices utilizing animal tissues and their derivatives - Application of risk management |
| BS EN ISO 22442-2-2008 | 医疗设备用动物组织及其衍生物.来源控制、采集和处理 | Medical devices utilizing animal tissues and their derivatives - Controls on sourcing, collection and handling |
| BS EN ISO 22442-3-2008 | 医疗设备用动物组织及其衍生物.病毒和传染性海绵状脑病(TSE)试剂的消灭和/或失效的确认 | Medical devices utilizing animal tissues and their derivatives - Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| BS EN ISO 22610-2007 | 病人和医务人员作为医疗用具的外科被单、长衣和无菌套装和设备.第3部分:性能要求和性能水平 | Surgical 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 |
| BS EN ISO 23747-2009 | 麻醉设备和医疗呼吸设备.自然呼吸的人类的肺功能测定用呼气峰值流量表 | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| BS EN ISO 5359-2008 | 医疗气体设备用低压软管组件 | Low-pressure hose assemblies for use with medical gases |
| BS EN ISO 7405-2008 | 牙科学.牙科用医疗器械生物相容性评估 | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| BS EN ISO 9170-1-2008 | 医疗气体管道系统用终端设备.医疗压缩气体和真空用终端设备 | Terminal units for medical gas pipeline systems - Terminal units for use with compressed medical gases and vacuum |
| BS EN ISO 9626-1991 | 医疗器具制造用的不锈钢针管 | Stainless steel needle tubing for the manufacture of medical devices |
| BS EN ISO 9919-2009 | 医疗电气设备.医用脉冲血氧仪基本安全和主要性能的特殊要求 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
| BS EN ISO10993-10-2002 | 医疗器械的生物评定.刺激与持续过敏症试验 | Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity |
| BS IEC 61223-2-10-2000 | 医疗成像部门的评估及例行试验.稳定性试验.乳房X线照相术用X射线设备 | Evaluation and routine testing in medical imaging departments - Constancy tests - X-ray equipment for mammography |
| BS IEC 61223-2-11-2000 | 医疗图象部门的评定和常规试验.稳定性试验.通用直接辐射摄影设备 | Evaluation and routine testing in medical imaging departments - Constancy tests - Equipment for general direct radiography |
| BS IEC 61223-2-7-2000 | 医疗成像部门的评估及例行试验.稳定性试验.不包括牙齿全景设备的口腔内牙科射线照相术用设备 | Evaluation and routine testing in medical imaging departments - Constancy tests - Equipment for intra-oral dental radiography excluding dental panoramic equipment |
| BS IEC 61223-2-9-2000 | 医疗成像部门的评估及例行试验.稳定性试验.间接放射线透视和间接射线照相术用设备 | Evaluation and routine testing in medical imaging departments - Constancy tests - Equipment for indirect radioscopy and indirect radiography |
| BS ISO 11073-90101-2008 | 健康信息学.床旁监护用医疗装置通信.分析仪器.床旁监护试验 | Health informatics - Point-of-care medical device communication - Analytical instruments - Point-of-care test |
| BS ISO 11195-1996 | 医疗用气体混合器.独立气体混合器 | Gas mixers for medical use - Stand-alone gas mixers |
| BS ISO 13606-2-2008 | 医疗信息学.电子健康记录信息.原型交换规范 | Health informatics - Electronic health record communication - Archetype interchange specification |
| BS ISO 15198-2004 | 临床实验室药物.体外诊断医疗设备.由制造商证实的用户质量控制程序 | Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer |
| BS ISO 16428-2005 | 外科植入物.可植入物质和医疗装置的静态和动态腐蚀试验用试验溶液和环境条件 | Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices |
| BS ISO 17090-1-2008 | 医疗信息学.公开密钥基础设施.数字证书服务的综述 | Health informatics - Public key infrastructure - Overview of digital certificate services |
| BS ISO 17432-2005 | 医疗信息学.文电和通信.DICOM持续对象的网上存取 | Health informatics - Messages and communication - Web access to DICOM persistent objects |
| BS ISO 17593-2007 | 临床实验室测试和体外医疗设备.口服抗凝血剂治疗自测用体外监测系统的要求 | Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| BS ISO 28620-2010 | 医疗设备.非电驱动的便携式输液设备 | Medical devices - Non-electrically driven portable infusion devices |
| BS ISO 4090-2001 | 摄影.医疗放射照相用X光底片盒/屏蔽物/胶片和硬拷贝成像胶片.尺寸和规范 | Photography - Medical radiographic cassettes/screens/films and hard-copy imaging films - Dimensions and specifications |
| BS ISO 5799-1995 | 摄影技术.医疗用和牙科用直接爆光射线摄影胶片/冲洗系统.ISO感光速度和ISO平均梯度的测定 | Photography - Direct-exposing medical and dental radiographic film/process systems - Determination of ISO speed and ISO average gradient |
| BS ISO 8600-2-2002 | 光学和光学仪器.医疗内诊镜和内诊镜附件.对刚性支气管镜的特殊要求 | Optics and optical instruments - Medical endoscopes and endoscopic accessories - Particular requirements for rigid bronchoscopes |
| BS ISO 8600-4-1997 | 光学和光学仪器.医疗用内诊镜和内诊镜附件.插入段最大宽度的测定 | Optics and optical instruments - Medical endoscopes and endoscopic accessories - Determination of maximum width of insertion portion |
| BS N 6-1998 | 航空医疗用便携式氧浓缩器系统规范.一般要求 | Specification for aeromedical portable oxygen concentrator systems - General requirements |
| BS PAS 131-2007 | 纳米技术的医疗、健康和个人护理设备用术语 | Terminology for medical, health and personal care applications of nanotechnology |
| DD ENV 12017-1998 | 医疗信息学.医疗信息学词汇(MIVoc) | Medical informatics. Medical informatics vocabulary (MIVoc) |
| DD ENV 12052-1998 | 医疗信息学.医疗成像通信(MEDICOM) | Medical informatics. Medical imaging communication (MEDICOM) |
| DD ENV 12264-1998 | 医疗信息学.概念体系分类结构.语义学表述模型 | Medical informatics. Categorical structures of systems of concepts. Model for representation of semantics |
| DD ENV 12435-2000 | 医疗信息学.医疗科学测量结果的表示 | Medical informatics. Expression of results of measurements in health sciences |
| DD ENV 12443-2001 | 医疗信息学.保健信息框架 | Medical informatics. Healthcare information framework (HIF) |
| DD ENV 12537-1-1998 | 医疗信息学.保健电子数据交换信息的信息对象登记.寄存器 | Medical informatics. Registration of information objects used for EDI in healthcare. The register |
| DD ENV 12537-2-1998 | 医疗信息学.保健电子数据交换用信息目标的注册.保健电子数据交换用信息目标的注册程序 | Medical informatics. Registration of information objects used for EDI in healthcare. Procedures for the registration of information objects used in electronic data interchange (EDI) in healthcare |
| DD ENV 12538-1998 | 医疗信息学.病人治疗安排和出院信息 | Medical informatics. Messages for patient referral and discharge |
| DD ENV 12539-1998 | 医疗信息学.诊断服务部门的要求和报告信息 | Medical informatics. Request and report messages for diagnostic service departments |
| DD ENV 12610-1998 | 医疗信息学.医疗产品鉴别 | Medical informatics. Medical product identification |
| DD ENV 12611-1998 | 医疗信息学.概念体系的分类结构.医疗设备 | Medical informatics. Categorical structure of systems of concepts. Medical devices |
| DD ENV 12612-1998 | 医疗信息学.保健管理信息交换用信息 | Medical informatics. Messages for the exchange of healthcare administrative information |
| DD ENV 12623-1998 | 医疗信息学.医疗成像通信的介质互换(MI-MEDICOM) | Medical informatics. Media interchange in Medical imaging communications (MI-MEDICOM) |
| DD ENV 12922-1-1998 | 医疗成像管理.存储委托服务类别 | Medical image management. Storage commitment service class |
| DD ENV 12924-1998 | 医疗信息学.保健信息系统的安全分类和保护 | Medical informatics. Security categorisation and protection for healthcare information systems |
| DD ENV 13607-2000 | 医疗卫生信息.医疗处方信息交换用信息 | Health informatics. Messages for the exchange of information on medicine prescriptions |
| DD ENV 13735-2001 | 健康信息学.病人身体接用的医疗设备间的互操作性 | Health informatics. Interoperability of patient connected medical devices |
| DD ENV 1613-1996 | 医疗信息学.实验室数据交换用信息 | Medical informatics. Messages for exchange of laboratory information |
| DD ENV 1828-1996 | 医疗信息学.外科程序分类和编码用结构 | Medical informatics. Structure for classification and coding of surgical procedures |
| PAS 131-2007 | 纳米技术应用在医疗、健康和个人护理的术语 | Terminology for medical,health and personal careapplications ofnanotechnology |
| PD 13058-1998 | 医疗数据互换:在ENV 12539-97和NEMA PS 3附录10规定的模型间的映象 | Medical data interchange: Mapping between the models specified in ENV 12539:1997 and NEMA PS 3 Supplement 10 |
| PD 6610-1997 | 医疗信息学.保健信息编制方法 | Medical informatics. Methodology for the development of healthcare messages |
| PD CEN/TR 15640-2007 | 医疗信息学.确保病人安全的医疗软件的测量 | Health informatics —Measures for ensuringthe patient safety ofhealth software |
| PD CR 14230-2001 | 管理数据交换用全球医疗设备命名 | Global medical device nomenclature for the purpose of regulatory data exchange |
| PD IEC TR 61010-3-041-2002 | 测量、控制和实验室用电气设备的安全要求.IEC 61010-2-041:1995的合格评定报告.医疗材料处理和实验室试验用 | Safety requirements for electrical equipment for measurement, control, and laboratory use. Conformity verification report for IEC 61010-2-041:1995. Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes |
| PD IEC TR 61010-3-042-2002 | 测量、控制和实验室用电气设备的安全要求.IEC 61010-2-042:1997.医疗材料处理和实验室处理用蒸压器和消毒器 | Safety requirements for electrical equipment for measurement, control, and laboratory use. Conformity verification report for IEC 61010-2-042:1997, particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes |
| PD IEC TR 61010-3-043-2002 | 测量、控制和实验室用电气设备的安全要求.IEC 61010-2-043:1997<医疗材料处理和实验室试验用热空气或热惰性 | Safety requirements for electrical equipment for measurement, control, and laboratory use. Conformity verification report for IEC 61010-2-043:1997. Particular requirements for dry heat sterilizers using either hot air or hot inert gas for treatment of medical materials and for laboratory processes |
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