| 编号 | 中文名称 | 英文名称 |
|---|---|---|
| ANSI INCITS284-1997 | 信息技术.识别卡.医疗保健识别卡 | Information Technology - Identification Cards - Health Care Identification Cards |
| ANSI IT2.41-1997 | 摄影.医疗放射照相术用屏蔽/胶片系统的感光测定.第1部分:感光曲线形状、速度和平均梯度的测定ANSI/ISO 9236 | Photography - Sensitometry of Screen/Film Systems for Medical Radiography - Part 1: Determination of Sensitometric Curve Shape, Speed and Average Gradient ANSI/ISO 9236-1-1996 |
| ANSI N42.17B-1989 | 健康医疗仪器的性能规范.职业性的空气中放射性物质的监控仪器 | Performance Specifications for Health Physics Instrumentation – Occupational Airborne Radioactivity Monitoring Instrumentation |
| ANSI N42.17C-1989 | 健康医疗仪器的性能规范.极端环境条件下使用的便携式仪器 | Radiation Instrumentation – Performance Specifications for Health Physics Instrumentation – Portable Instrumentation for Use in Extreme Environmental Conditions |
| ANSI N43.3-2008 | 一般辐射安全.用于非医疗的X射线和密封γ射线源辐射安全能量小于10Mev(兆电子伏特)的装置 | General Radiation Safety - Installations Using Non-Medical X-Ray and Sealed Gamma-Ray Sources, Energies Up to 10 MeV |
| ANSI P1073.1.1.1/D08-2003 | 健康信息学用标准草案.床旁检测用医疗装置通信.术语 | Draft Standard for Health informatics – Point-of-care medical devicecommunication – Nomenclature |
| ANSI P1073.1.2.1/D06-2003 | 健康信息学用标准草案.床旁检测用医疗装置通信.域信息模型 | Draft Health Informatics - Point-of-care medicaldevice communications - Domain information model |
| ANSI P1073.1.3.10/D3.0-1999 | 医疗装置通信用标准草案.专用虚拟医疗装置的医疗装置数据语言(MDDL).心输出量 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Cardiac Output |
| ANSI P1073.1.3.11/D3.0-1999 | 医疗装置通信用标准草案.专用虚拟医疗装置的医疗装置数据语言(MDDL).二氧化碳测定计 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Capnometer |
| ANSI P1073.1.3.5/D04-2000 | 医疗装置通信用标准草案.专用虚拟医疗装置的医疗装置数据语言(MDDL).去纤颤器装置 | Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized -Defibrillator Device |
| ANSI P1073.1.3.6/D6.0-1999 | 医疗装置通信用标准草案.专用虚拟医疗装置的医疗装置数据语言(MDDL).心电图 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized -ECG |
| ANSI P1073.1.3.7/D4.0-1999 | 医疗装置通信用标准草案.专用虚拟医疗装置的医疗装置数据语言(MDDL).血压 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Blood Pressure |
| ANSI P1073.1.3.8/D4.0-1999 | 医疗装置通信用标准草案.专用虚拟医疗装置的医疗装置数据语言(MDDL).温度 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Temperature |
| ANSI P1073.1.3.9/D3.0-1999 | 医疗装置通信用标准草案.专用虚拟医疗装置的医疗装置数据语言(MDDL).导氮管流 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Airway Flow |
| ANSI P1073.2.1.1/D08-2003 | 健康信息学用标准草案.床旁检测用医疗装置通信.应用轮廓.基础标准 | Draft Standard for Health informatics - Point-of-care medical devicecommunication - Application profiles - Base standard |
| ANSI P1073.3.3/D08-2003 | 健康信息学用标准草案.床旁检测用医疗装置通信.传输轮廓.基于IrDA.红外无线 | Draft Standard for Health informatics - Point-of-care medical devicecommunication - Transport profile - IrDA based - Infrared wireless |
| ANSI PH2.50-1983 | 摄影.医疗和牙科用直接曝光射线摄影胶片/照相版图片的ISO感光速度和平均梯度的测定 | Photography - Direct-Exposure Medical and Dental Radiographic Film/Process Combinations - Determination of ISO Speed and Average Gradient |
| ANSI/AAMI BE78-2002 | 医疗设施生物评估.第10部分:刺激作用和致敏作用试验 | Biological evaluation of medical devices, Part 10: Tests for irritation and delayed type hypersensitivity |
| ANSI/AAMI BE78-2002/A1-2006 | 医疗装置的生物学评估.第10部分:刺激和迟延型超敏性试验.修改件1 | Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1 |
| ANSI/AAMI BE83-2006 | 医疗器械的生物评价.第18部分:材料的化学特性 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials |
| ANSI/AAMI DF80-2003 | 医疗电气设备.第2部分:心脏除颤器安全性的特殊要求(包括体外心脏电击去颤器) | Medical electrical equipment - Part 2: Particular requirements for the safety of cardiac defibrillators [including automated external defibrillators] |
| ANSI/AAMI EC13-2002 | 医疗电气设备.第2-27部分:心电图仪用监控设备的基本安全和性能的特殊要求 | Medical electrical equipment - Part 2-27: Particular requirements for basic safety and essential performance of electrocardiographic monitoring equipment |
| ANSI/AAMI EC38-2007 | 医疗电气设备.第2-47部分:非固定式心电图仪系统的安全(包括基本性能)的特殊要求 | Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, or ambulatory electrocardiographic systems |
| ANSI/AAMI EQ56-1999 | 医疗设备管理项目的推荐实施规范 | Recommended practices for a medical equipment management program |
| ANSI/AAMI ES60601-1-2005 | 医疗电器设备.第一部分:基本安全和实用性的一般要求 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance |
| ANSI/AAMI ES60601-1/Amendment 1-2009 | 医疗电气设备,第1部分:基本安全性和必要性能一般要求 | Medical electrical equipment, Part 1: General requirements for basic safety and essential performance |
| ANSI/AAMI ES60601-1/Amendment 2-2010 | 医疗电气设备.第1部分:基本安全性和必要性能一般要求.修改件2 | Medical electrical equipment, Part 1: General requirements for basic safety and essential performance/Amendment 2 |
| ANSI/AAMI HE74-2001 | 医疗装置人性因素设计过程 | Human factors design process for medical devices |
| ANSI/AAMI HE75-2009 | 人因工程学.医疗设备设计 | Human factors engineering - Design of medical devices |
| ANSI/AAMI ID26-2004 | 医疗电气设备.第2部分:注液泵和控制器安全的特殊要求 | Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers |
| ANSI/AAMI PB70-2003 | 医疗保健设施中使用的防护服和防护布的防液性能和分类 | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| ANSI/AAMI PC69-2007 | 活性可植入医疗装置.电磁兼容性(EMC).可植入心脏起搏器和可植入心律转复除颤器用EMC试验协议 | Active Implantable Medical Devices - Electromagnetic Compatibility - EMC Test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators |
| ANSI/AAMI ST 63-2002 | 保健品灭菌.医疗器械工业灭菌过程的设计、批准和常规控制要求.干热 | Sterilization of Health Care Products - Requirements for the development,validation,and routine control of an industrial sterilization process for medical devices - Dry heat |
| ANSI/AAMI ST25-1987 | 医疗产品的工业湿热灭菌用指南 | Guideline for Industrial Moist Heat Sterilization of Medical Products |
| ANSI/AAMI ST27-1988 | 医疗设备的工业环氧乙烷灭菌用指南.工艺流程设计、验证、例行灭菌和合同灭菌 | Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization |
| ANSI/AAMI ST29-1988 | 医疗设备中残留环氧乙烷的测定用推荐实施规程 | Recommended Practice for Determining Residual Ethylene Oxide in Medical Devices |
| ANSI/AAMI ST30-1989 | 医疗设备中残留氯乙醇和乙二醇的测定 | Determining Residual Ethylene Chlorohydrin and Ethylene Glycol in Medical Devices |
| ANSI/AAMI ST58-2005 | 医疗保健设施中化学药剂杀菌和高水平消毒 | Chemical sterilization and high-level disinfection in health care facilities |
| ANSI/AAMI ST67-2003 | 医疗装置的消毒.贴有"已消毒"标签的产品要求 | Sterilization of medical devices - Requirements for products labeled "sterile" |
| ANSI/AAMI ST77-2006 | 可再利用的医疗设备杀菌用密封装置 | Containment devices for reusable medical device sterilization |
| ANSI/AAMI ST79-2006 | 医疗设备中蒸汽消毒和灭菌保证用综合指南 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
| ANSI/AAMI ST81-2004 | 医疗器件的消毒.由生产商提供的可反复消毒的医疗器件的处理信息 | Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices |
| ANSI/AAMI/IEC 60601-2-19-2009 | 医疗电气设备.第2-19部分:婴儿保育器基本安全和重要性能的特殊要求 | Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators |
| ANSI/AAMI/IEC 60601-2-20-2009 | 医疗电气设备.第2-20部分:运输保育箱基本安全和重要性能的特殊要求 | Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators |
| ANSI/AAMI/IEC 60601-2-21-2009 | 医疗电气设备.第2-21部分:婴儿辐射温热装置基本安全和重要性能的特殊要求 | Medical electrical equipment - Part 2-21: Particular requirements for basic safety and essential performance of infant radiant warmers |
| ANSI/AAMI/IEC 62304,Ed.1-2006 | 医疗器械用软件.软件寿命循环过程 | Medical device software - Software life-cycle processes |
| ANSI/AAMI/IEC 80601-2-30-2009 | 医疗电气设备.第2-30部分:自动无创伤性血压计的基本安全和性能的专用要求 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| ANSI/AAMI/IEC 80601-2-30-2009/C1-2009 | 医疗电气设备.第2-30部分:自动无创伤性血压计的基本安全和性能的详细要求 | Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers |
| ANSI/AAMI/IEC 80601-2-58-2008 | 医疗电气设备.第2-58部分:眼外科用晶状体移除装置和玻璃体切除装置基本安全及重要性能的特殊要求 | Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy device for ophthalmic surgery |
| ANSI/AAMI/ISO 10993-1-2009 | 医疗器械的生物学评价.第1部分:风险管理系统内的评价与测试 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system |
| ANSI/AAMI/ISO 10993-11-2006 | 医疗器械的生物评定.第11部分:系统毒性试验(收集在ANSI/AAMI/ISO 10993-1993汇编集中) | Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity (included in ANSI/AAMI/ISO 10993-1993: A collection) |
| ANSI/AAMI/ISO 10993-12-2007 | 医疗器械的生物评价.第12部分:样品制备和标样 | Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials |
| ANSI/AAMI/ISO 10993-13-1999 | 医疗器械的生物学评价.第13部分:聚合物医疗器械降解产物的定性与定量 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymers |
| ANSI/AAMI/ISO 10993-14-2001 | 医疗器械的生物评定.第14部分:来自陶瓷的降解产品的识别和量化 | Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics |
| ANSI/AAMI/ISO 10993-15-2000 | 医疗器械的生物学评价.第15部分:金属与合金降解产物的识别与定量 | Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys |
| ANSI/AAMI/ISO 10993-16-1997 | 医疗器械的生物评定.第16部分:降解产品和可沥滤物质毒性动态研究设计 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
| ANSI/AAMI/ISO 10993-17-2002 | 医疗器械的生物评估.第17部分:可滤出物质允许极限值的确定 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| ANSI/AAMI/ISO 10993-2-2006 | 医疗器械的生物评定.第2部分:动物福利要求 | Biological evaluation of medical devices - Part 2: Animal welfare requirements |
| ANSI/AAMI/ISO 10993-3-2003 | 医疗器械的生物评定.第3部分:基因毒性、致癌作用和生殖毒性的测试 | Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ANSI/AAMI/ISO 10993-4-2002 | 医疗器械的生物评定.第4部分:与血液相互作用的试验的选择 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood |
| ANSI/AAMI/ISO 10993-4AMD 1-2006 | 医疗器械的生物评定.第4部分:与血液相互作用的试验的选择(修改件1) | Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood (Amendment 1) |
| ANSI/AAMI/ISO 10993-5-2009 | 医疗器械生物学评价.第5部分:体外细胞毒性试验 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ANSI/AAMI/ISO 10993-6-2007 | 医疗装置的生物学评估.第6部分:植入后局部效应的试验 | Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects after Implantation |
| ANSI/AAMI/ISO 10993-7-2008 | 医疗装置用生物学评估.第7部分:环氧乙烷灭菌残留物 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals |
| ANSI/AAMI/ISO 11135-1-2007 | 卫生保健品灭菌.环氧乙烷.第1部分:医疗设备灭菌过程开发、确认和常规控制的要求 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO 11137-1-2006 | 保健产品的灭菌.辐射.第1部分:医疗装置消毒的开发、确认和程序控制的要求 | Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO 11138-1-2006 | 医疗保健产品灭菌.生物指示器.第1部分:一般要求 | Sterilization of health care products - Biological indicators - Part 1: General requirements |
| ANSI/AAMI/ISO 11138-2-2006 | 医疗保健产品灭菌.生物指示器.第2部分:环氧乙烷灭菌处理用生物指示器 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes |
| ANSI/AAMI/ISO 11138-3-2006 | 医疗保健产品灭菌.生物指示物.第3部分:湿热灭菌处理用生物指示剂 | Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes |
| ANSI/AAMI/ISO 11138-4-2006 | 医疗保健产品灭菌.生物指示器.第4部分:干热灭菌处理用生物指示器 | Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes |
| ANSI/AAMI/ISO 11138-5-2006 | 医疗保健产品灭菌.生物指示器.第5部分:甲醛溶液灭菌处理用生物指示器 | Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| ANSI/AAMI/ISO 11607-1-2006 | 最后灭菌的医疗器械的包装.第1部分:原材料、消毒阻挡系统和包装的要求 | Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging |
| ANSI/AAMI/ISO 11607-2-2006 | 最后灭菌的医疗器械的包装.第2部分:组成、密封和装配过程的确认和要求 | Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes |
| ANSI/AAMI/ISO 11737-1-2006 | 医疗器械消毒.微生物法.第1部分:产品微生物群落数测定 | Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products |
| ANSI/AAMI/ISO 11737-2-2009 | 医疗器械灭菌.微生物学方法.第2部分:定义、确认及维持灭菌过程中进行的无菌试验 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ANSI/AAMI/ISO 13408-2-2003 | 医疗保健产品的无菌加工.第2部分:过滤 | Aseptic Processing of health care products - Part 2: Filtration |
| ANSI/AAMI/ISO 13485-2003 | 医疗设备.质量管理体系.管理用系统要求 | Medical devices - Quality management systems - Requirements for regulatory purposes |
| ANSI/AAMI/ISO 14155-1-2003 | 医疗器械的临床调查 | Clinical investigation of medical devices for human subjects - Part 1: General requirements |
| ANSI/AAMI/ISO 14155-2-2003 | 受治疗人员用医疗器械的临床调查.第二部分：临床调查计划 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans |
| ANSI/AAMI/ISO 14160-1998 | 对包括动物源材料在内的一次性使用医疗器具的灭菌.使用液体化学灭菌剂的确认和常规控制 | Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants |
| ANSI/AAMI/ISO 14708-3-2008 | 外科植入物.可植入式医疗器械.第3部分:可植入神经刺激器 | Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
| ANSI/AAMI/ISO 14708-4-2008 | 外科植入物.有源植入式医疗设备.第4部分:植入式输液泵 | Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps |
| ANSI/AAMI/ISO 14708-5-2010 | 外科植入物.有源可植入医疗装置.第5部分:循环支撑装置 | Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
| ANSI/AAMI/ISO 14937-2000 | 医疗保健产品灭菌.医用设备用消毒剂的特性及消毒方法的开发、确认和常规控制的一般要求 | Sterilization of Health Care Products - General Requirements for Characteristics of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process |
| ANSI/AAMI/ISO 14971-2007 | 医疗器械.风险管理.医疗器械风险管理的应用 | Medical devices - Risk management - Application of risk management to medical devices |
| ANSI/AAMI/ISO 15223-1-2007 | 医疗设备.用于医疗设备标签、加标签和提供信息的符号.第1部分:一般要求 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements |
| ANSI/AAMI/ISO 15223-1/A1-2008 | 医疗器械.用于医疗器械标签、标记和提供信息的符号 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied |
| ANSI/AAMI/ISO 15223-2-2010 | 医疗器械.用于医疗器械标签、作标记和提供信息的符号.第2部分:符号的制定、筛选和批准 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation |
| ANSI/AAMI/ISO 15225-2010 | 命名法.医疗设备命名数据结构 | Nomenclature - Medical device nomenclature data structure |
| ANSI/AAMI/ISO 17665-1-2005 | 医疗保健产品.湿热.医疗装置消毒的开发、确认和程序控制的要求 | Sterilization of health care products - Moist heat - Requirements for development, validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO 22442-1-2007 | 医疗设备用动物组织及其衍生物.第1部分:风险管理的应用 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| ANSI/AAMI/ISO 22442-2-2007 | 医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
| ANSI/AAMI/ISO 22442-3-2007 | 医疗设备用动物组织及其衍生物.第3部分:病毒和遗传性海绵状脑病(TSE)试剂的消灭和/或失效的确认 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ANSI/ASHRAE 170a-2009 | 医疗卫生设施的通风 | Ventilation of Health Care Facilities |
| ANSI/ASTM E1744-2005 | 电子健康记录中紧急医疗的观测规范 | Practice for View of Emergency Medical Care in the Electronic Health Record |
| ANSI/ASTM E1762-1997 | 医疗保健信息电子鉴定规范 | Guide for Electronic Authentication of Health Care Information |
| ANSI/ASTM E1959-2006 | 医疗保健机构医药处方服务提议要求的标准指南 | Guide for Requests for Proposals Regarding Medical Transcription Services for Healthcare Institutions |
| ANSI/ASTM E2017-1999 | 医疗信息修改件指南 | Guide for Amendments to Health Information |
| ANSI/ASTM E2084-2000 | 用数字签名证明医疗保健信息规范 | Specification for Authentication of Healthcare Information using Digital Signatures |
| ANSI/ASTM E2085-2001 | 医疗保健信息安全框架指南 | Guide on Security Framework for Healthcare Information |
| ANSI/ASTM E2086-2000 | 因特网和内部网医疗保健安全保密指南 | Guide for Internet and Intranet Healthcare Security |
| ANSI/ASTM E2117-2006 | 医疗记录质量保证计划的鉴定和确立用分类指南 | Classifications Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription |
| ANSI/ASTM E2502-2006 | 医疗转录工作站的标准指南 | Standard Guide for Medical Transcription Workstations |
| ANSI/ASTM E2538-2007 | 电子医疗记录环境和网络体系机构内定义和执行药物疗法信息服务的实施规程 | Practice for Defining and Implementing Pharmacotherapy Information Services Within the Electronic Health Record Environment and Networked Architectures |
| ANSI/ASTM E2682-2009 | 医疗转录部门和事务用灾难恢复方案开发的指南 | Guide for Developing a Disaster Recovery Plan for Medical Transcription Departments and Businesses |
| ANSI/ASTM F2290-2003 | 医疗气体用ISO 5359低压软管组件的采用 | Adoption of ISO 5359 Low-pressure Hose Assemblies for Use with Medical Gases |
| ANSI/ASTM F2402-2004 | 与医疗气体管道系统终端装置相连的流量测量装置.采用ISO 15002作为美国国家标准(有所偏差) | Flow-metering Devices for Connection to Terminal Units of Medical Gas Pipeline Systems, Adoption of ISO 15002 as an American National Standard (with Deviations) |
| ANSI/ASTM/ISO 21647-2006 | 医疗电气设备.呼吸气体监测器的基本安全性能的特殊要求 | Medical Electrical Equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| ANSI/ASTM/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 |
| ANSI/AWS D10.13/D 10.13M-2001 | 医疗气体系统用铜管和管道钎焊的推荐规程 | Recommended Practices for the Brazing of Copper Pipe and Tubing for Medical Gas Systems |
| ANSI/CAP SNOMED-1-2003 | 医疗保健术语结构 | Healthcare Terminology Structure |
| ANSI/HL 7CDAR 1.0-2000 | HL7版3标准:医疗数据结构,发表1.0 | The HL7 Version 3 Standard: Clinical Data Architecture, Release 1.0 |
| ANSI/HL7 V3 RBAC, R 2-2010 | HL7版本3标准:基于任务的访问控制医疗审批目录.版本2 | HL7 Version 3 Standard: Role-based Access Control Healthcare Permission Catalog, Release 2 |
| ANSI/HL7 V3 RCMR, R 1-2006 | HL7第3版标准:医疗记录/信息管理.版本1 | HL7 Version 3 Standard: Medical Records/Information Management, Release 1 |
| ANSI/HL7 V3 SPDIR, R 1-2010 | HL7版本3标准:医疗保健,社区服务部和供应商名录,发行1 | HL7 Version 3 Standard: Healthcare,Community Services and Provider Directory, Release 1 |
| ANSI/IEEE 1073.1.1.1-2004 | 健康信息学标准.床旁检测用医疗装置通信.术语 | Standard for Health Informatics – Point-of-Care Medical Device Communication – Nomenclature |
| ANSI/IEEE 1073.1.2.1-2004 | 健康信息学标准.床旁检测用医疗装置通信.域信息模式 | Standard for Health Informatics – Point-of-Care Medical Device Communication – Domain Information Model |
| ANSI/IEEE 1073.2.1.1-2004 | 健康信息学标准.床旁检测用医疗装置通信.应用轮廓.基础标准 | Standard for Health Informatics – Point-of-Care Medical Device Communication – Application Profiles – Base Standard |
| ANSI/IEEE 1073.3.2-2000 | 医疗装置通信.传输轮廓.以IrDA为基的连接电缆 | Medical Device Communications - Transport Profile - IrDA Based - Cable Connected |
| ANSI/IEEE 1073.3.3-2004 | 健康信息学标准.床旁检测用医疗装置通信.传输轮廓.基于IrDA的红外无线 | Standard for Health Informatics – Point-of-Care Medical Device Communication – Transport Profile – IrDA Based – Infrared Wireless |
| ANSI/IEEE 11073-00101-2008 | 健康信息指南.医疗服务点的医疗器械通信.技术报告使用指南 | Guide for Health Informatics - Point-of-Care Medical Device Communication - Technical Report - Guidelines for the Use |
| ANSI/IEEE 602-2007 | 医疗保健设施用电子系统的推荐实施规程 | Recommended Practice for Electric Systems in Health Care Facilities |
| ANSI/IEEE C63.011-2000 | 测量工业、科技、医疗射频设备的抗无线电干扰特性的限值和方法 | Limits and Methods of Measurement of Radio Disturbance Characteristics of Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment |
| ANSI/NAPM IT2.41-1997 | 摄影.医疗放射照相术用屏蔽/胶片系统的感光测定.第1部分:感光曲线形状、速度和平均梯度的测定 | Photography - Sensitometry of Screen/Film Systems for Medical Radiography - Part 1: Determination of Sensitometric Curve Shape, Speed and Average Gradient |
| ANSI/NCPDP MSV 3.0-2007 | 批次标准版本3.0用医疗补助代理执行指南 | Medicaid Subrogation Implementation Guide for Batch Standard Version 3.0 |
| ANSI/NFPA 1582-2007 | 消防队的全职医疗计划标准 | Standard on Comprehensive Occupational Medical Program for Fire Departments |
| ANSI/NFPA 1710-2010 | 职业消防队灭火操作,急救医疗操作和特殊操作的组织和调度标准 | Standard for the Organization and Deployment of Fire Suppression Operations, Emergency Medical Operations, and Special Operations to the Public by Career Fire Departments |
| ANSI/NFPA 1720-2010 | 专业消防部门消防行动,紧急医疗事故处理和特别行动组织和部署标准 | Standard for the Organization and Deployment of Fire Suppression Operations, Emergency Medical Operations and Special Operations to the Public by Volunteer Fire Departments |
| ANSI/NFPA 1999-2008 | 急救医疗手术用防护服的标准 | Standard on Protective Clothing for Emergency Medical Operations |
| ANSI/NFPA 450-2009 | 应急医疗设施和系统用指南 | Guide for Emergency Medical Services and Systems |
| ASTM ANS/IEC60601.2.12-2001 | 医疗用电气设备.第2-12部分:对于肺通气器安全性的特殊要求.重症护理(被批准为美国国家标准,与ASTM国际标准 | Medical Electrical Equipment&8212;Part 2-12; Particular Requirements for the Safety of Lung Ventilators&8212;Critical Care Ventilators Approved as an American National Standard with Deviations by ASTM International |
| ASTM ANS/ISO15002-2000 | 连接医疗气体管道系统终端装置的流量计量仪表 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| ASTM ANS/ISO5359-2000E | 偏离ASTM国际组织批准成为美国国家标准的与医疗气体一同使用的低压软管组件 | Low-Pressure Hose Assemblies for Use with Medical Gases Approved as an American National Standard with Deviations by ASTM International |
| ASTM ANSI/ISO21647-2004 | 医疗电气设备.8212呼吸监测器的基本安全和基本性能的特殊要求 | Medical Electrical Equipment&8212Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors |
| ASTM E1902-2002 | 口授、录音和录制的医疗记录的机密性和安全性的管理标准规范 | Standard Specification for Management of the Confidentiality and Security of Dictation, Transcription, and Transcribed Health Records |
| ASTM E1959-2005 | 视为医疗保健机构医药处方服务建议要求的标准指南 | Standard Guide for Requests for Proposals Regarding Medical Transcription Services for Healthcare Institutions |
| ASTM E2117-2006 | 医疗记录质量保证计划的鉴定和确立用标准指南 | Standard Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription |
| ASTM E2436-2005 | 医疗信息系统中人类特征数据表示法的标准规范 | Standard Specification for the Representation of Human Characteristics Data in Healthcare Information Systems |
| ASTM E2502-2006 | 医疗摹本工作站的标准指南 | Standard Guide for Medical Transcription Workstations |
| ASTM E2682-2009 | 医疗转移科和职业用灾祸恢复方案开发的标准指南 | Standard Guide for Developing a Disaster Recovery Plan for Medical Transcription Departments and Businesses |
| ASTM F1031-2000(2006) | 急救医疗技师培训(基础)的标准操作规程 | Standard Practice for Training the Emergency Medical Technician (Basic) |
| ASTM F1220-1995(2006) | 应急医疗服务系统(EMSS)远程通信 | Standard Guide for Emergency Medical Services System (EMSS) Telecommunications |
| ASTM F1224-1989(2004)e1 | 提供急救医疗服务系统评定用标准指南 | Standard Guide for Providing System Evaluation for Emergency Medical Services |
| ASTM F1229-2001(2006) | 急救医疗服务机上患者医疗护理人员的资格鉴定和训练计划的标准指南 | Standard Guide for the Qualification and Training of EMS Air-Medical Patient Care Providers |
| ASTM F1251-1989(2003) | 医疗和外科器械用聚合生物材料的相关术语 | Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices |
| ASTM F1258-1995(2006) | 应急医疗调度 | Standard Practice for Emergency Medical Dispatch |
| ASTM F1287-1990(2007) | 提供应急医疗护理的急救应答器性能范围 | Standard Guide for Scope of Performance of First Responders Who Provide Emergency Medical Care |
| ASTM F1560-2000(2006) | 医疗紧急调度管理标准实施规程 | Standard Practice for Emergency Medical Dispatch Management |
| ASTM F1629-1995(2007) | 建立外科手术的急救医疗服务和管理信息系统或二者同时建立的标准导则 | Standard Guide for Establishing Operating Emergency Medical Services and Management Information Systems, or Both |
| ASTM F1652-1995(2007) | 为住院前应急医疗机构提前提供所需主要数据的标准指南 | Standard Guide for Providing Essential Data Needed in Advance for Prehospital Emergency Medical Services |
| ASTM F1705-1996(2007) | 紧急医疗救护服务操作训练用标准指南 | Standard Guide for Training Emergency Medical Services Ambulance Operations |
| ASTM F1800-2007 | 整体膝关节替代物的医疗胫骨盘部件的周期疲劳测试的标准试验方法 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F1929-1998(2004) | 用染色渗透液检测多孔医疗包装汽封泄漏的标准试验方法 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| ASTM F1980-2007 | 医疗装置用无菌阻隔系统加速老化的标准指南 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ASTM F2038-2000(2005) | 医疗设施中用的硅弹性体、凝胶和泡沫的标准指南.第I部分:组成和未硫化材料 | Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| ASTM F2042-2000(2005) | 医疗设施中用的硅弹性体、凝胶和泡沫的标准指南.第II部分:交联材料和制造 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
| ASTM F2052-2006e1 | 测量磁共振环境中医疗设备磁感应位移力的标准试验方法 | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ASTM F2063-2005 | 医疗器械和外科植入物用锻造镍钛形状记忆合金标准规范 | Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants |
| ASTM F2076-2001(2006) | EMS病人报告关于接收医疗设备的通知的标准实施规程 | Standard Practice for Communicating an EMS Patient Report to Receiving Medical Facilities |
| ASTM F2150-2007 | 组织工程医疗产品中使用的生物材料支架的表征和试验用标准指南 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F2210-2002 | 组织工程医疗产品中使用的细胞、组织和器官处理的标准指南 | Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products |
| ASTM F2211-2004 | 组织工程医疗产品的标准分类 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| ASTM F2213-2006 | 磁共振环境中医疗设备中磁感应扭矩测量的标准试验方法 | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| ASTM F2318-2004 | 旋转机翼的基本生命保障、高级生命保障和专业医疗保障救护飞机的标准规格 | Standard Specification for Rotary Wing Basic Life Support, Advanced Life Support, and Specialized Medical Support Air Ambulances |
| ASTM F2319-2004 | 固定机翼的基本生命保障、高级生命保障和专业医疗保障救护飞机的标准规格 | Standard Specification for Fixed Wing Basic Life Support, Advanced Life Support, and Specialized Medical Support Air Ambulances |
| ASTM F2347-2003 | 生物医疗和组织工程医疗产品中使用的作为初始材料的透明质酸盐的表征和试验标准指南 | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| ASTM F2382-2004e1 | 根据部分促凝血酶原激酶时间评估血管内医疗设备材料的标准试验方法 | Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) |
| ASTM F2383-2005 | 组织工程医疗产品中附加剂评定的标准指南 | Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) |
| ASTM F2386-2004 | 组织工程医疗产品的保存的标准指南 | Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) |
| ASTM F2459-2005 | 从金属医疗部件提取残余物并经由化学分离测重法确定数量的标准试验方法 | Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
| ASTM F2475-2005 | 医疗器件包装材料的生物可兼容性评价的标准指南 | Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| ASTM F2633-2007 | 医疗设备和外科植入物用可锻无缝镍钛形状记忆合金管标准规范 | Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
| ASTM F2761-2009 | 医疗器械和医疗系统.包含病人的设备用基础安全要求.中心综合临床环境(ICE).第1部分:一般要求和概念模型 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| ASTM F561-2005a | 医疗器件和相关组织及液体的修复和分析的标准实施规程 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
| ASTM F640-2007 | 医疗用辐射不透明度测定的标准试验方法 | Standard Test Methods for Determining Radiopacity for Medical Use |
| ASTM F813-2007 | 直接接触细胞培养评估医疗器械材料的标准实施规程 | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| ASTM F882-1984(2002) | 低温外科医疗器械的性能和安全 | Standard Performance and Safety Specification for Cryosurgical Medical Instruments |
| ASTM G175-2003 | 医疗和应急设备用氧气调节器的引燃敏感性和耐故障性评价的标准试验方法 | Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications |
| IEEE C 63.011-2000 | 测量工业、科技、医疗射频设备的抗无线电干扰特性的限值和方法 | (Limits and methods of measurement of radio disturbance characteristics of Industrial, Scientific, and Medical (ISM) radio-frequency equipment) |
| IEEE C 63.18-1997 | 医疗设备防特定射频发射器电磁辐射干扰评估的现场特别试验方法推荐规程 | (Recommended practice for an on-site, ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radio-frequency transmitters) |
| UL 416-1993 | 制冷医疗设备 | (Refrigerated medical equipment ) |
| UL 544-1998 | 医疗和牙科设备 | (Medical and dental equipment ) |
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