| 編號 | 中文名稱 | 英文名稱 |
|---|---|---|
| ANSI INCITS284-1997 | 信息技術(shù).識別卡.醫(yī)療保健識別卡 | Information Technology - Identification Cards - Health Care Identification Cards |
| ANSI IT2.41-1997 | 攝影.醫(yī)療放射照相術(shù)用屏蔽/膠片系統(tǒng)的感光測定.第1部分:感光曲線形狀、速度和平均梯度的測定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 | 健康醫(yī)療儀器的性能規(guī)范.職業(yè)性的空氣中放射性物質(zhì)的監(jiān)控儀器 | Performance Specifications for Health Physics Instrumentation – Occupational Airborne Radioactivity Monitoring Instrumentation |
| ANSI N42.17C-1989 | 健康醫(yī)療儀器的性能規(guī)范.極端環(huán)境條件下使用的便攜式儀器 | Radiation Instrumentation – Performance Specifications for Health Physics Instrumentation – Portable Instrumentation for Use in Extreme Environmental Conditions |
| ANSI N43.3-2008 | 一般輻射安全.用于非醫(yī)療的X射線和密封γ射線源輻射安全能量小于10Mev(兆電子伏特)的裝置 | 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 | 健康信息學(xué)用標(biāo)準(zhǔn)草案.床旁檢測用醫(yī)療裝置通信.術(shù)語 | Draft Standard for Health informatics – Point-of-care medical devicecommunication – Nomenclature |
| ANSI P1073.1.2.1/D06-2003 | 健康信息學(xué)用標(biāo)準(zhǔn)草案.床旁檢測用醫(yī)療裝置通信.域信息模型 | Draft Health Informatics - Point-of-care medicaldevice communications - Domain information model |
| ANSI P1073.1.3.10/D3.0-1999 | 醫(yī)療裝置通信用標(biāo)準(zhǔn)草案.專用虛擬醫(yī)療裝置的醫(yī)療裝置數(shù)據(jù)語言(MDDL).心輸出量 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Cardiac Output |
| ANSI P1073.1.3.11/D3.0-1999 | 醫(yī)療裝置通信用標(biāo)準(zhǔn)草案.專用虛擬醫(yī)療裝置的醫(yī)療裝置數(shù)據(jù)語言(MDDL).二氧化碳測定計 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Capnometer |
| ANSI P1073.1.3.5/D04-2000 | 醫(yī)療裝置通信用標(biāo)準(zhǔn)草案.專用虛擬醫(yī)療裝置的醫(yī)療裝置數(shù)據(jù)語言(MDDL).去纖顫器裝置 | Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized -Defibrillator Device |
| ANSI P1073.1.3.6/D6.0-1999 | 醫(yī)療裝置通信用標(biāo)準(zhǔn)草案.專用虛擬醫(yī)療裝置的醫(yī)療裝置數(shù)據(jù)語言(MDDL).心電圖 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized -ECG |
| ANSI P1073.1.3.7/D4.0-1999 | 醫(yī)療裝置通信用標(biāo)準(zhǔn)草案.專用虛擬醫(yī)療裝置的醫(yī)療裝置數(shù)據(jù)語言(MDDL).血壓 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Blood Pressure |
| ANSI P1073.1.3.8/D4.0-1999 | 醫(yī)療裝置通信用標(biāo)準(zhǔn)草案.專用虛擬醫(yī)療裝置的醫(yī)療裝置數(shù)據(jù)語言(MDDL).溫度 | Draft Standard forMedical Device Communications -Medical Device Data Language (MDDL)Virtual Medical Device, Specialized –Temperature |
| ANSI P1073.1.3.9/D3.0-1999 | 醫(yī)療裝置通信用標(biāo)準(zhǔn)草案.專用虛擬醫(yī)療裝置的醫(yī)療裝置數(shù)據(jù)語言(MDDL).導(dǎo)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 | 健康信息學(xué)用標(biāo)準(zhǔn)草案.床旁檢測用醫(yī)療裝置通信.應(yīng)用輪廓.基礎(chǔ)標(biāo)準(zhǔn) | Draft Standard for Health informatics - Point-of-care medical devicecommunication - Application profiles - Base standard |
| ANSI P1073.3.3/D08-2003 | 健康信息學(xué)用標(biāo)準(zhǔn)草案.床旁檢測用醫(yī)療裝置通信.傳輸輪廓.基于IrDA.紅外無線 | Draft Standard for Health informatics - Point-of-care medical devicecommunication - Transport profile - IrDA based - Infrared wireless |
| ANSI PH2.50-1983 | 攝影.醫(yī)療和牙科用直接曝光射線攝影膠片/照相版圖片的ISO感光速度和平均梯度的測定 | Photography - Direct-Exposure Medical and Dental Radiographic Film/Process Combinations - Determination of ISO Speed and Average Gradient |
| ANSI/AAMI BE78-2002 | 醫(yī)療設(shè)施生物評估.第10部分:刺激作用和致敏作用試驗 | Biological evaluation of medical devices, Part 10: Tests for irritation and delayed type hypersensitivity |
| ANSI/AAMI BE78-2002/A1-2006 | 醫(yī)療裝置的生物學(xué)評估.第10部分:刺激和遲延型超敏性試驗.修改件1 | Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1 |
| ANSI/AAMI BE83-2006 | 醫(yī)療器械的生物評價.第18部分:材料的化學(xué)特性 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials |
| ANSI/AAMI DF80-2003 | 醫(yī)療電氣設(shè)備.第2部分:心臟除顫器安全性的特殊要求(包括體外心臟電擊去顫器) | Medical electrical equipment - Part 2: Particular requirements for the safety of cardiac defibrillators [including automated external defibrillators] |
| ANSI/AAMI EC13-2002 | 醫(yī)療電氣設(shè)備.第2-27部分:心電圖儀用監(jiān)控設(shè)備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 | 醫(yī)療電氣設(shè)備.第2-47部分:非固定式心電圖儀系統(tǒng)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 | 醫(yī)療設(shè)備管理項目的推薦實施規(guī)范 | Recommended practices for a medical equipment management program |
| ANSI/AAMI ES60601-1-2005 | 醫(yī)療電器設(shè)備.第一部分:基本安全和實用性的一般要求 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance |
| ANSI/AAMI ES60601-1/Amendment 1-2009 | 醫(yī)療電氣設(shè)備,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 | 醫(yī)療電氣設(shè)備.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 | 醫(yī)療裝置人性因素設(shè)計過程 | Human factors design process for medical devices |
| ANSI/AAMI HE75-2009 | 人因工程學(xué).醫(yī)療設(shè)備設(shè)計 | Human factors engineering - Design of medical devices |
| ANSI/AAMI ID26-2004 | 醫(yī)療電氣設(shè)備.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 | 醫(yī)療保健設(shè)施中使用的防護服和防護布的防液性能和分類 | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| ANSI/AAMI PC69-2007 | 活性可植入醫(yī)療裝置.電磁兼容性(EMC).可植入心臟起搏器和可植入心律轉(zhuǎn)復(fù)除顫器用EMC試驗協(xié)議 | Active Implantable Medical Devices - Electromagnetic Compatibility - EMC Test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators |
| ANSI/AAMI ST 63-2002 | 保健品滅菌.醫(yī)療器械工業(yè)滅菌過程的設(shè)計、批準(zhǔn)和常規(guī)控制要求.干熱 | 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 | 醫(yī)療產(chǎn)品的工業(yè)濕熱滅菌用指南 | Guideline for Industrial Moist Heat Sterilization of Medical Products |
| ANSI/AAMI ST27-1988 | 醫(yī)療設(shè)備的工業(yè)環(huán)氧乙烷滅菌用指南.工藝流程設(shè)計、驗證、例行滅菌和合同滅菌 | Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization |
| ANSI/AAMI ST29-1988 | 醫(yī)療設(shè)備中殘留環(huán)氧乙烷的測定用推薦實施規(guī)程 | Recommended Practice for Determining Residual Ethylene Oxide in Medical Devices |
| ANSI/AAMI ST30-1989 | 醫(yī)療設(shè)備中殘留氯乙醇和乙二醇的測定 | Determining Residual Ethylene Chlorohydrin and Ethylene Glycol in Medical Devices |
| ANSI/AAMI ST58-2005 | 醫(yī)療保健設(shè)施中化學(xué)藥劑殺菌和高水平消毒 | Chemical sterilization and high-level disinfection in health care facilities |
| ANSI/AAMI ST67-2003 | 醫(yī)療裝置的消毒.貼有"已消毒"標(biāo)簽的產(chǎn)品要求 | Sterilization of medical devices - Requirements for products labeled "sterile" |
| ANSI/AAMI ST77-2006 | 可再利用的醫(yī)療設(shè)備殺菌用密封裝置 | Containment devices for reusable medical device sterilization |
| ANSI/AAMI ST79-2006 | 醫(yī)療設(shè)備中蒸汽消毒和滅菌保證用綜合指南 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
| ANSI/AAMI ST81-2004 | 醫(yī)療器件的消毒.由生產(chǎn)商提供的可反復(fù)消毒的醫(yī)療器件的處理信息 | 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 | 醫(yī)療電氣設(shè)備.第2-19部分:嬰兒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 | 醫(yī)療電氣設(shè)備.第2-20部分:運輸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 | 醫(yī)療電氣設(shè)備.第2-21部分:嬰兒輻射溫?zé)嵫b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 | 醫(yī)療器械用軟件.軟件壽命循環(huán)過程 | Medical device software - Software life-cycle processes |
| ANSI/AAMI/IEC 80601-2-30-2009 | 醫(yī)療電氣設(shè)備.第2-30部分:自動無創(chuàng)傷性血壓計的基本安全和性能的專用要求 | 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 | 醫(yī)療電氣設(shè)備.第2-30部分:自動無創(chuàng)傷性血壓計的基本安全和性能的詳細要求 | 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 | 醫(yī)療電氣設(shè)備.第2-58部分:眼外科用晶狀體移除裝置和玻璃體切除裝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 | 醫(yī)療器械的生物學(xué)評價.第1部分:風(fēng)險管理系統(tǒng)內(nèi)的評價與測試 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system |
| ANSI/AAMI/ISO 10993-11-2006 | 醫(yī)療器械的生物評定.第11部分:系統(tǒng)毒性試驗(收集在ANSI/AAMI/ISO 10993-1993匯編集中) | 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 | 醫(yī)療器械的生物評價.第12部分:樣品制備和標(biāo)樣 | Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials |
| ANSI/AAMI/ISO 10993-13-1999 | 醫(yī)療器械的生物學(xué)評價.第13部分:聚合物醫(yī)療器械降解產(chǎn)物的定性與定量 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymers |
| ANSI/AAMI/ISO 10993-14-2001 | 醫(yī)療器械的生物評定.第14部分:來自陶瓷的降解產(chǎn)品的識別和量化 | Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics |
| ANSI/AAMI/ISO 10993-15-2000 | 醫(yī)療器械的生物學(xué)評價.第15部分:金屬與合金降解產(chǎn)物的識別與定量 | Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys |
| ANSI/AAMI/ISO 10993-16-1997 | 醫(yī)療器械的生物評定.第16部分:降解產(chǎn)品和可瀝濾物質(zhì)毒性動態(tài)研究設(shè)計 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
| ANSI/AAMI/ISO 10993-17-2002 | 醫(yī)療器械的生物評估.第17部分:可濾出物質(zhì)允許極限值的確定 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| ANSI/AAMI/ISO 10993-2-2006 | 醫(yī)療器械的生物評定.第2部分:動物福利要求 | Biological evaluation of medical devices - Part 2: Animal welfare requirements |
| ANSI/AAMI/ISO 10993-3-2003 | 醫(yī)療器械的生物評定.第3部分:基因毒性、致癌作用和生殖毒性的測試 | Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ANSI/AAMI/ISO 10993-4-2002 | 醫(yī)療器械的生物評定.第4部分:與血液相互作用的試驗的選擇 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood |
| ANSI/AAMI/ISO 10993-4AMD 1-2006 | 醫(yī)療器械的生物評定.第4部分:與血液相互作用的試驗的選擇(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 | 醫(yī)療器械生物學(xué)評價.第5部分:體外細胞毒性試驗 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ANSI/AAMI/ISO 10993-6-2007 | 醫(yī)療裝置的生物學(xué)評估.第6部分:植入后局部效應(yīng)的試驗 | Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects after Implantation |
| ANSI/AAMI/ISO 10993-7-2008 | 醫(yī)療裝置用生物學(xué)評估.第7部分:環(huán)氧乙烷滅菌殘留物 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals |
| ANSI/AAMI/ISO 11135-1-2007 | 衛(wèi)生保健品滅菌.環(huán)氧乙烷.第1部分:醫(yī)療設(shè)備滅菌過程開發(fā)、確認和常規(guī)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 | 保健產(chǎn)品的滅菌.輻射.第1部分:醫(yī)療裝置消毒的開發(fā)、確認和程序控制的要求 | 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 | 醫(yī)療保健產(chǎn)品滅菌.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 | 醫(yī)療保健產(chǎn)品滅菌.生物指示器.第2部分:環(huán)氧乙烷滅菌處理用生物指示器 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes |
| ANSI/AAMI/ISO 11138-3-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物.第3部分:濕熱滅菌處理用生物指示劑 | Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes |
| ANSI/AAMI/ISO 11138-4-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示器.第4部分:干熱滅菌處理用生物指示器 | Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes |
| ANSI/AAMI/ISO 11138-5-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示器.第5部分:甲醛溶液滅菌處理用生物指示器 | 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 | 最后滅菌的醫(yī)療器械的包裝.第1部分:原材料、消毒阻擋系統(tǒng)和包裝的要求 | Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging |
| ANSI/AAMI/ISO 11607-2-2006 | 最后滅菌的醫(yī)療器械的包裝.第2部分:組成、密封和裝配過程的確認和要求 | Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes |
| ANSI/AAMI/ISO 11737-1-2006 | 醫(yī)療器械消毒.微生物法.第1部分:產(chǎn)品微生物群落數(shù)測定 | Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products |
| ANSI/AAMI/ISO 11737-2-2009 | 醫(yī)療器械滅菌.微生物學(xué)方法.第2部分:定義、確認及維持滅菌過程中進行的無菌試驗 | 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 | 醫(yī)療保健產(chǎn)品的無菌加工.第2部分:過濾 | Aseptic Processing of health care products - Part 2: Filtration |
| ANSI/AAMI/ISO 13485-2003 | 醫(yī)療設(shè)備.質(zhì)量管理體系.管理用系統(tǒng)要求 | Medical devices - Quality management systems - Requirements for regulatory purposes |
| ANSI/AAMI/ISO 14155-1-2003 | 醫(yī)療器械的臨床調(diào)查 | Clinical investigation of medical devices for human subjects - Part 1: General requirements |
| ANSI/AAMI/ISO 14155-2-2003 | 受治療人員用醫(yī)療器械的臨床調(diào)查.第二部分：臨床調(diào)查計劃 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans |
| ANSI/AAMI/ISO 14160-1998 | 對包括動物源材料在內(nèi)的一次性使用醫(yī)療器具的滅菌.使用液體化學(xué)滅菌劑的確認和常規(guī)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.可植入式醫(yī)療器械.第3部分:可植入神經(jīng)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.有源植入式醫(yī)療設(shè)備.第4部分:植入式輸液泵 | Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps |
| ANSI/AAMI/ISO 14708-5-2010 | 外科植入物.有源可植入醫(yī)療裝置.第5部分:循環(huán)支撐裝置 | Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
| ANSI/AAMI/ISO 14937-2000 | 醫(yī)療保健產(chǎn)品滅菌.醫(yī)用設(shè)備用消毒劑的特性及消毒方法的開發(fā)、確認和常規(guī)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 | 醫(yī)療器械.風(fēng)險管理.醫(yī)療器械風(fēng)險管理的應(yīng)用 | Medical devices - Risk management - Application of risk management to medical devices |
| ANSI/AAMI/ISO 15223-1-2007 | 醫(yī)療設(shè)備.用于醫(yī)療設(shè)備標(biāo)簽、加標(biāo)簽和提供信息的符號.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 | 醫(yī)療器械.用于醫(yī)療器械標(biāo)簽、標(biāo)記和提供信息的符號 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied |
| ANSI/AAMI/ISO 15223-2-2010 | 醫(yī)療器械.用于醫(yī)療器械標(biāo)簽、作標(biāo)記和提供信息的符號.第2部分:符號的制定、篩選和批準(zhǔn) | 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.醫(yī)療設(shè)備命名數(shù)據(jù)結(jié)構(gòu) | Nomenclature - Medical device nomenclature data structure |
| ANSI/AAMI/ISO 17665-1-2005 | 醫(yī)療保健產(chǎn)品.濕熱.醫(yī)療裝置消毒的開發(fā)、確認和程序控制的要求 | 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 | 醫(yī)療設(shè)備用動物組織及其衍生物.第1部分:風(fēng)險管理的應(yīng)用 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| ANSI/AAMI/ISO 22442-2-2007 | 醫(yī)療設(shè)備用動物組織及其衍生物.第2部分:來源控制、采集和處理 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
| ANSI/AAMI/ISO 22442-3-2007 | 醫(yī)療設(shè)備用動物組織及其衍生物.第3部分:病毒和遺傳性海綿狀腦病(TSE)試劑的消滅和/或失效的確認 | 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 | 醫(yī)療衛(wèi)生設(shè)施的通風(fēng) | Ventilation of Health Care Facilities |
| ANSI/ASTM E1744-2005 | 電子健康記錄中緊急醫(yī)療的觀測規(guī)范 | Practice for View of Emergency Medical Care in the Electronic Health Record |
| ANSI/ASTM E1762-1997 | 醫(yī)療保健信息電子鑒定規(guī)范 | Guide for Electronic Authentication of Health Care Information |
| ANSI/ASTM E1959-2006 | 醫(yī)療保健機構(gòu)醫(yī)藥處方服務(wù)提議要求的標(biāo)準(zhǔn)指南 | Guide for Requests for Proposals Regarding Medical Transcription Services for Healthcare Institutions |
| ANSI/ASTM E2017-1999 | 醫(yī)療信息修改件指南 | Guide for Amendments to Health Information |
| ANSI/ASTM E2084-2000 | 用數(shù)字簽名證明醫(yī)療保健信息規(guī)范 | Specification for Authentication of Healthcare Information using Digital Signatures |
| ANSI/ASTM E2085-2001 | 醫(yī)療保健信息安全框架指南 | Guide on Security Framework for Healthcare Information |
| ANSI/ASTM E2086-2000 | 因特網(wǎng)和內(nèi)部網(wǎng)醫(yī)療保健安全保密指南 | Guide for Internet and Intranet Healthcare Security |
| ANSI/ASTM E2117-2006 | 醫(yī)療記錄質(zhì)量保證計劃的鑒定和確立用分類指南 | Classifications Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription |
| ANSI/ASTM E2502-2006 | 醫(yī)療轉(zhuǎn)錄工作站的標(biāo)準(zhǔn)指南 | Standard Guide for Medical Transcription Workstations |
| ANSI/ASTM E2538-2007 | 電子醫(yī)療記錄環(huán)境和網(wǎng)絡(luò)體系機構(gòu)內(nèi)定義和執(zhí)行藥物療法信息服務(wù)的實施規(guī)程 | Practice for Defining and Implementing Pharmacotherapy Information Services Within the Electronic Health Record Environment and Networked Architectures |
| ANSI/ASTM E2682-2009 | 醫(yī)療轉(zhuǎn)錄部門和事務(wù)用災(zāi)難恢復(fù)方案開發(fā)的指南 | Guide for Developing a Disaster Recovery Plan for Medical Transcription Departments and Businesses |
| ANSI/ASTM F2290-2003 | 醫(yī)療氣體用ISO 5359低壓軟管組件的采用 | Adoption of ISO 5359 Low-pressure Hose Assemblies for Use with Medical Gases |
| ANSI/ASTM F2402-2004 | 與醫(yī)療氣體管道系統(tǒng)終端裝置相連的流量測量裝置.采用ISO 15002作為美國國家標(biāo)準(zhǔn)(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 | 醫(yī)療電氣設(shè)備.呼吸氣體監(jiān)測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 | 醫(yī)療電氣設(shè)備.醫(yī)用脈沖血氧儀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 | 醫(yī)療氣體系統(tǒng)用銅管和管道釬焊的推薦規(guī)程 | Recommended Practices for the Brazing of Copper Pipe and Tubing for Medical Gas Systems |
| ANSI/CAP SNOMED-1-2003 | 醫(yī)療保健術(shù)語結(jié)構(gòu) | Healthcare Terminology Structure |
| ANSI/HL 7CDAR 1.0-2000 | HL7版3標(biāo)準(zhǔn):醫(yī)療數(shù)據(jù)結(jié)構(gòu),發(fā)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標(biāo)準(zhǔn):基于任務(wù)的訪問控制醫(yī)療審批目錄.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版標(biāo)準(zhǔn):醫(yī)療記錄/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標(biāo)準(zhǔn):醫(yī)療保健,社區(qū)服務(wù)部和供應(yīng)商名錄,發(fā)行1 | HL7 Version 3 Standard: Healthcare,Community Services and Provider Directory, Release 1 |
| ANSI/IEEE 1073.1.1.1-2004 | 健康信息學(xué)標(biāo)準(zhǔn).床旁檢測用醫(yī)療裝置通信.術(shù)語 | Standard for Health Informatics – Point-of-Care Medical Device Communication – Nomenclature |
| ANSI/IEEE 1073.1.2.1-2004 | 健康信息學(xué)標(biāo)準(zhǔn).床旁檢測用醫(yī)療裝置通信.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 | 健康信息學(xué)標(biāo)準(zhǔn).床旁檢測用醫(yī)療裝置通信.應(yīng)用輪廓.基礎(chǔ)標(biāo)準(zhǔn) | Standard for Health Informatics – Point-of-Care Medical Device Communication – Application Profiles – Base Standard |
| ANSI/IEEE 1073.3.2-2000 | 醫(yī)療裝置通信.傳輸輪廓.以IrDA為基的連接電纜 | Medical Device Communications - Transport Profile - IrDA Based - Cable Connected |
| ANSI/IEEE 1073.3.3-2004 | 健康信息學(xué)標(biāo)準(zhǔn).床旁檢測用醫(yī)療裝置通信.傳輸輪廓.基于IrDA的紅外無線 | 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.醫(yī)療服務(wù)點的醫(yī)療器械通信.技術(shù)報告使用指南 | Guide for Health Informatics - Point-of-Care Medical Device Communication - Technical Report - Guidelines for the Use |
| ANSI/IEEE 602-2007 | 醫(yī)療保健設(shè)施用電子系統(tǒng)的推薦實施規(guī)程 | Recommended Practice for Electric Systems in Health Care Facilities |
| ANSI/IEEE C63.011-2000 | 測量工業(yè)、科技、醫(yī)療射頻設(shè)備的抗無線電干擾特性的限值和方法 | Limits and Methods of Measurement of Radio Disturbance Characteristics of Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment |
| ANSI/NAPM IT2.41-1997 | 攝影.醫(yī)療放射照相術(shù)用屏蔽/膠片系統(tǒng)的感光測定.第1部分:感光曲線形狀、速度和平均梯度的測定 | 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 | 批次標(biāo)準(zhǔn)版本3.0用醫(yī)療補助代理執(zhí)行指南 | Medicaid Subrogation Implementation Guide for Batch Standard Version 3.0 |
| ANSI/NFPA 1582-2007 | 消防隊的全職醫(yī)療計劃標(biāo)準(zhǔn) | Standard on Comprehensive Occupational Medical Program for Fire Departments |
| ANSI/NFPA 1710-2010 | 職業(yè)消防隊滅火操作,急救醫(yī)療操作和特殊操作的組織和調(diào)度標(biāo)準(zhǔn) | 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 | 專業(yè)消防部門消防行動,緊急醫(yī)療事故處理和特別行動組織和部署標(biāo)準(zhǔn) | 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 | 急救醫(yī)療手術(shù)用防護服的標(biāo)準(zhǔn) | Standard on Protective Clothing for Emergency Medical Operations |
| ANSI/NFPA 450-2009 | 應(yīng)急醫(yī)療設(shè)施和系統(tǒng)用指南 | Guide for Emergency Medical Services and Systems |
| ASTM ANS/IEC60601.2.12-2001 | 醫(yī)療用電氣設(shè)備.第2-12部分:對于肺通氣器安全性的特殊要求.重癥護理(被批準(zhǔn)為美國國家標(biāo)準(zhǔn),與ASTM國際標(biāo)準(zhǔn) | 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 | 連接醫(yī)療氣體管道系統(tǒng)終端裝置的流量計量儀表 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| ASTM ANS/ISO5359-2000E | 偏離ASTM國際組織批準(zhǔn)成為美國國家標(biāo)準(zhǔn)的與醫(yī)療氣體一同使用的低壓軟管組件 | Low-Pressure Hose Assemblies for Use with Medical Gases Approved as an American National Standard with Deviations by ASTM International |
| ASTM ANSI/ISO21647-2004 | 醫(yī)療電氣設(shè)備.8212呼吸監(jiān)測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、錄音和錄制的醫(yī)療記錄的機密性和安全性的管理標(biāo)準(zhǔn)規(guī)范 | Standard Specification for Management of the Confidentiality and Security of Dictation, Transcription, and Transcribed Health Records |
| ASTM E1959-2005 | 視為醫(yī)療保健機構(gòu)醫(yī)藥處方服務(wù)建議要求的標(biāo)準(zhǔn)指南 | Standard Guide for Requests for Proposals Regarding Medical Transcription Services for Healthcare Institutions |
| ASTM E2117-2006 | 醫(yī)療記錄質(zhì)量保證計劃的鑒定和確立用標(biāo)準(zhǔn)指南 | Standard Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription |
| ASTM E2436-2005 | 醫(yī)療信息系統(tǒng)中人類特征數(shù)據(jù)表示法的標(biāo)準(zhǔn)規(guī)范 | Standard Specification for the Representation of Human Characteristics Data in Healthcare Information Systems |
| ASTM E2502-2006 | 醫(yī)療摹本工作站的標(biāo)準(zhǔn)指南 | Standard Guide for Medical Transcription Workstations |
| ASTM E2682-2009 | 醫(yī)療轉(zhuǎn)移科和職業(yè)用災(zāi)禍恢復(fù)方案開發(fā)的標(biāo)準(zhǔn)指南 | Standard Guide for Developing a Disaster Recovery Plan for Medical Transcription Departments and Businesses |
| ASTM F1031-2000(2006) | 急救醫(yī)療技師培訓(xùn)(基礎(chǔ))的標(biāo)準(zhǔn)操作規(guī)程 | Standard Practice for Training the Emergency Medical Technician (Basic) |
| ASTM F1220-1995(2006) | 應(yīng)急醫(yī)療服務(wù)系統(tǒng)(EMSS)遠程通信 | Standard Guide for Emergency Medical Services System (EMSS) Telecommunications |
| ASTM F1224-1989(2004)e1 | 提供急救醫(yī)療服務(wù)系統(tǒng)評定用標(biāo)準(zhǔn)指南 | Standard Guide for Providing System Evaluation for Emergency Medical Services |
| ASTM F1229-2001(2006) | 急救醫(yī)療服務(wù)機上患者醫(yī)療護理人員的資格鑒定和訓(xùn)練計劃的標(biāo)準(zhǔn)指南 | Standard Guide for the Qualification and Training of EMS Air-Medical Patient Care Providers |
| ASTM F1251-1989(2003) | 醫(yī)療和外科器械用聚合生物材料的相關(guān)術(shù)語 | Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices |
| ASTM F1258-1995(2006) | 應(yīng)急醫(yī)療調(diào)度 | Standard Practice for Emergency Medical Dispatch |
| ASTM F1287-1990(2007) | 提供應(yīng)急醫(yī)療護理的急救應(yīng)答器性能范圍 | Standard Guide for Scope of Performance of First Responders Who Provide Emergency Medical Care |
| ASTM F1560-2000(2006) | 醫(yī)療緊急調(diào)度管理標(biāo)準(zhǔn)實施規(guī)程 | Standard Practice for Emergency Medical Dispatch Management |
| ASTM F1629-1995(2007) | 建立外科手術(shù)的急救醫(yī)療服務(wù)和管理信息系統(tǒng)或二者同時建立的標(biāo)準(zhǔn)導(dǎo)則 | Standard Guide for Establishing Operating Emergency Medical Services and Management Information Systems, or Both |
| ASTM F1652-1995(2007) | 為住院前應(yīng)急醫(yī)療機構(gòu)提前提供所需主要數(shù)據(jù)的標(biāo)準(zhǔn)指南 | Standard Guide for Providing Essential Data Needed in Advance for Prehospital Emergency Medical Services |
| ASTM F1705-1996(2007) | 緊急醫(yī)療救護服務(wù)操作訓(xùn)練用標(biāo)準(zhǔn)指南 | Standard Guide for Training Emergency Medical Services Ambulance Operations |
| ASTM F1800-2007 | 整體膝關(guān)節(jié)替代物的醫(yī)療脛骨盤部件的周期疲勞測試的標(biāo)準(zhǔn)試驗方法 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F1929-1998(2004) | 用染色滲透液檢測多孔醫(yī)療包裝汽封泄漏的標(biāo)準(zhǔn)試驗方法 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| ASTM F1980-2007 | 醫(yī)療裝置用無菌阻隔系統(tǒng)加速老化的標(biāo)準(zhǔn)指南 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ASTM F2038-2000(2005) | 醫(yī)療設(shè)施中用的硅彈性體、凝膠和泡沫的標(biāo)準(zhǔn)指南.第I部分:組成和未硫化材料 | Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| ASTM F2042-2000(2005) | 醫(yī)療設(shè)施中用的硅彈性體、凝膠和泡沫的標(biāo)準(zhǔn)指南.第II部分:交聯(lián)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 | 測量磁共振環(huán)境中醫(yī)療設(shè)備磁感應(yīng)位移力的標(biāo)準(zhǔn)試驗方法 | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ASTM F2063-2005 | 醫(yī)療器械和外科植入物用鍛造鎳鈦形狀記憶合金標(biāo)準(zhǔn)規(guī)范 | Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants |
| ASTM F2076-2001(2006) | EMS病人報告關(guān)于接收醫(yī)療設(shè)備的通知的標(biāo)準(zhǔn)實施規(guī)程 | Standard Practice for Communicating an EMS Patient Report to Receiving Medical Facilities |
| ASTM F2150-2007 | 組織工程醫(yī)療產(chǎn)品中使用的生物材料支架的表征和試驗用標(biāo)準(zhǔn)指南 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F2210-2002 | 組織工程醫(yī)療產(chǎn)品中使用的細胞、組織和器官處理的標(biāo)準(zhǔn)指南 | Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products |
| ASTM F2211-2004 | 組織工程醫(yī)療產(chǎn)品的標(biāo)準(zhǔn)分類 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| ASTM F2213-2006 | 磁共振環(huán)境中醫(yī)療設(shè)備中磁感應(yīng)扭矩測量的標(biāo)準(zhǔn)試驗方法 | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| ASTM F2318-2004 | 旋轉(zhuǎn)機翼的基本生命保障、高級生命保障和專業(yè)醫(yī)療保障救護飛機的標(biāo)準(zhǔn)規(guī)格 | Standard Specification for Rotary Wing Basic Life Support, Advanced Life Support, and Specialized Medical Support Air Ambulances |
| ASTM F2319-2004 | 固定機翼的基本生命保障、高級生命保障和專業(yè)醫(yī)療保障救護飛機的標(biāo)準(zhǔn)規(guī)格 | Standard Specification for Fixed Wing Basic Life Support, Advanced Life Support, and Specialized Medical Support Air Ambulances |
| ASTM F2347-2003 | 生物醫(yī)療和組織工程醫(yī)療產(chǎn)品中使用的作為初始材料的透明質(zhì)酸鹽的表征和試驗標(biāo)準(zhǔn)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 | 根據(jù)部分促凝血酶原激酶時間評估血管內(nèi)醫(yī)療設(shè)備材料的標(biāo)準(zhǔn)試驗方法 | Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) |
| ASTM F2383-2005 | 組織工程醫(yī)療產(chǎn)品中附加劑評定的標(biāo)準(zhǔn)指南 | Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) |
| ASTM F2386-2004 | 組織工程醫(yī)療產(chǎn)品的保存的標(biāo)準(zhǔn)指南 | Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) |
| ASTM F2459-2005 | 從金屬醫(yī)療部件提取殘余物并經(jīng)由化學(xué)分離測重法確定數(shù)量的標(biāo)準(zhǔn)試驗方法 | Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
| ASTM F2475-2005 | 醫(yī)療器件包裝材料的生物可兼容性評價的標(biāo)準(zhǔn)指南 | Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| ASTM F2633-2007 | 醫(yī)療設(shè)備和外科植入物用可鍛無縫鎳鈦形狀記憶合金管標(biāo)準(zhǔn)規(guī)范 | Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
| ASTM F2761-2009 | 醫(yī)療器械和醫(yī)療系統(tǒng).包含病人的設(shè)備用基礎(chǔ)安全要求.中心綜合臨床環(huán)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 | 醫(yī)療器件和相關(guān)組織及液體的修復(fù)和分析的標(biāo)準(zhǔn)實施規(guī)程 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
| ASTM F640-2007 | 醫(yī)療用輻射不透明度測定的標(biāo)準(zhǔn)試驗方法 | Standard Test Methods for Determining Radiopacity for Medical Use |
| ASTM F813-2007 | 直接接觸細胞培養(yǎng)評估醫(yī)療器械材料的標(biāo)準(zhǔn)實施規(guī)程 | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| ASTM F882-1984(2002) | 低溫外科醫(yī)療器械的性能和安全 | Standard Performance and Safety Specification for Cryosurgical Medical Instruments |
| ASTM G175-2003 | 醫(yī)療和應(yīng)急設(shè)備用氧氣調(diào)節(jié)器的引燃敏感性和耐故障性評價的標(biāo)準(zhǔn)試驗方法 | 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 | 測量工業(yè)、科技、醫(yī)療射頻設(shè)備的抗無線電干擾特性的限值和方法 | (Limits and methods of measurement of radio disturbance characteristics of Industrial, Scientific, and Medical (ISM) radio-frequency equipment) |
| IEEE C 63.18-1997 | 醫(yī)療設(shè)備防特定射頻發(fā)射器電磁輻射干擾評估的現(xiàn)場特別試驗方法推薦規(guī)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 | 制冷醫(yī)療設(shè)備 | (Refrigerated medical equipment ) |
| UL 544-1998 | 醫(yī)療和牙科設(shè)備 | (Medical and dental equipment ) |
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