| 編號 | 中文名稱 | 英文名稱 |
|---|---|---|
| CISPR 11 AMD 2-2006 | 工業(yè)用,科研用以及醫(yī)療用(ISM)射頻設(shè)備.電磁干擾特性.限值和測量方法.修改件2 | Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement; Amendment 2 |
| CISPR 11-2003 | 工業(yè),科研和醫(yī)療(ISM)用射頻設(shè)備.電磁干擾特性.限值和測量方法.注:本文件及其單獨(dú)的修正件均與合并版本同時(shí) | Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement / Note: This document and its separate amendments continue to be valid together with the consolidated version * To be replaced by CISPR/B/418/CDV (2006-12), CISPR/B/434/CD (2007-07), CISPR/B/435/CDV (2007-07), CISPR/B/440/CDV (2007-08, t). * To be amended by CISPR/B/324/FDIS (2004-02), CISPR/B/394/FDIS (2006-03), CISPR/B/459/CDV (2008-04). |
| CISPR 28-1997 | 工業(yè),科學(xué)和醫(yī)療設(shè)備(ISM).國際電信聯(lián)盟(ITU)指定頻段內(nèi)的輻射電平指南 | Industrial, scientific and medical equipment (ISM) - Guidelines for emission levels within the bands designated by the ITU |
| IEC 60336 Corrigendum 1-2006 | 醫(yī)用電氣設(shè)備.醫(yī)療診斷用X射線管組件.焦點(diǎn)特性.勘誤1 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots; Corrigendum 1 |
| IEC 60336-2005 | 醫(yī)療電氣設(shè)備.醫(yī)療診斷用X射線管組件.焦點(diǎn)的特性 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| IEC 60364-7-710-2002 | 建筑物的電氣設(shè)施.第7-710部分:特殊設(shè)施或場所的要求.醫(yī)療場所 | Electrical installations of buildings - Part 7-710: Requirements for special installations or locations; Medical locations |
| IEC 60601-1 Corrigendum 1-2006 | 醫(yī)療電氣設(shè)備.第1部分:基本安全和實(shí)用性的一般要求.技術(shù)勘誤1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Corrigendum 1 |
| IEC 60601-1 Interpretation Sheet 1-2008 | 醫(yī)療電氣設(shè)備.第1部分:基本安全和重要性能的一般要求 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1 Interpretation Sheet 2-2009 | 醫(yī)療電氣設(shè)備.第1部分:基本安全和基本性能的通用要求.解釋清單2 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Interpretation sheet 2 |
| IEC 60601-1-11-2010 | 醫(yī)療電氣設(shè)備.第1-11部分:基本安全和重要性能的一般要求.附屬標(biāo)準(zhǔn):家庭保健用醫(yī)療電氣設(shè)備和醫(yī)療電氣系統(tǒng)的 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| IEC 60601-1-4-1996 | 醫(yī)療電氣設(shè)備.第1部分:安全的一般要求.第4節(jié):對照標(biāo)準(zhǔn):程序控制的電氣醫(yī)療系統(tǒng) | Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems |
| IEC 60601-1-4-2000 | 醫(yī)療用電氣設(shè)備.第1-4部分:一般安全性要求.并行標(biāo)準(zhǔn):可編程電氣醫(yī)療系統(tǒng) | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems |
| IEC 60601-1-8-2006 | 醫(yī)用電氣設(shè)備.第1-8部分:基本安全和基本性能通用要求.匯編標(biāo)準(zhǔn):醫(yī)療電氣設(shè)備和醫(yī)療電氣系統(tǒng)中警報(bào)系統(tǒng)的一 | Medical electrical equipment - Part 1-8: 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 |
| IEC 60601-1-9-2007 | 醫(yī)療電氣設(shè)備.第1-9部分:基本安全和重要性能的一般要求.附屬標(biāo)準(zhǔn):環(huán)境意識設(shè)計(jì)的要求 | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| IEC 60601-2-13 Edition 3.1-2009 | 醫(yī)療電氣設(shè)備.第2-13部分:麻醉系統(tǒng)安全性的特殊要求 | Medical electrical equipment - Part 2-13: Particular requirements for the safety of anaesthetic systems |
| IEC 60601-2-18-2009 | 醫(yī)療電氣設(shè)備.第2-18部分:內(nèi)窺鏡設(shè)備基本安全和主要性能的特殊要求 | Medical electrical equipment - Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment |
| IEC 60601-2-22-2007 | 醫(yī)療電氣設(shè)備.第2-22部分:外科、整容、治療和診斷用激光設(shè)備基本安全和基本性能的特殊要求 | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60601-2-28-2010 | 醫(yī)用電氣設(shè)備.第2-28部分:醫(yī)療診斷用X射線管組件的基本安全和基本性能用特殊要求 | Medical electrical equipment - Part 2-28: Particular requirements for basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| IEC 60601-2-29-2008 | 醫(yī)療電氣設(shè)備.第2-29部分:放射療法模擬器的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 safety and essential performance of radiotherapy simulators |
| IEC 60601-2-33-2010 | 醫(yī)用電氣設(shè)備.第2-33部分:醫(yī)療診斷用磁共振設(shè)備的基本安全和基本性能用特殊要求 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| IEC 60601-2-37-2007 | 醫(yī)療電氣設(shè)備.第2-37部分:超聲波醫(yī)療診斷和監(jiān)測設(shè)備的基本安全和基本性能用特殊要求 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| IEC 60601-2-41-2009 | 醫(yī)療電氣設(shè)備.第2-41部分:診斷用手術(shù)照明和燈具的基本安全和基本性能的特殊要求 | Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
| IEC 60601-2-50-2009 | 醫(yī)療電氣設(shè)備.第2-50部分:嬰兒光線療法設(shè)備的基本安全及重要性能用特殊要求 | Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| IEC 60601-2-52-2009 | 醫(yī)療電氣設(shè)備.第2-52部分:醫(yī)用病床的基本安全及基本性能的詳細(xì)要求 | Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds |
| IEC 60601-2-8-1987 | 醫(yī)療電氣設(shè)備.第2部分:治療用X射線發(fā)生器安全的特殊要求 | Medical electrical equipment. Part 2 : Particular requirements for the safety of therapeutic X-ray generators |
| IEC 60613-2010 | 醫(yī)療診斷用X射線管組件的電氣和負(fù)載特性 | Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis |
| IEC 60789 Corrigendum 1-2009 | 醫(yī)療電氣設(shè)備.放射性核素成象裝置的特性和試驗(yàn)條件.安格型伽馬射線照相機(jī).勘誤表1 | Medical electrical equipment - Characteristics and test conditions of radionuclide imaging devices - Anger type gamma cameras; Corrigendum 1 |
| IEC 60806-1984 | 醫(yī)療診斷旋轉(zhuǎn)陽極X射線管最大對稱輻射場的測定 | Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis |
| IEC 61010-2-040-2005 | 測量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求.第2-040部分:處理醫(yī)療材料用滅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 |
| IEC 61010-2-101-2002 | 測量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求.第2-101部分:實(shí)驗(yàn)室診斷(IVD)醫(yī)療設(shè)備的特殊要求 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
| IEC 61157 Corrigendum 1-2008 | 醫(yī)療診斷超聲波設(shè)備的聲輸出報(bào)告用標(biāo)準(zhǔn)方法.技術(shù)勘誤1 | Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment; Corrigendum 1 |
| IEC 61157-2007 | 醫(yī)療診斷超聲波設(shè)備聲輸出的報(bào)告用標(biāo)準(zhǔn)方法 | Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
| IEC 61223-3-5 Corrigendum 1-2006 | 醫(yī)療成像部門的評價(jià)和常規(guī)檢驗(yàn).第3-5部分:驗(yàn)收試驗(yàn).計(jì)算機(jī)斷層攝影X射線設(shè)備的成像性能.勘誤1 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment; Corrigendum 1 |
| IEC 61326-2-6 Corrigendum 1-2007 | 測量、控制和實(shí)驗(yàn)室用電氣設(shè)備.電磁兼容性(EMC)要求.第2-6部分:特殊要求.體外診斷(IVD)醫(yī)療設(shè)備.技術(shù)勘誤1 | Electrical equipment for measurement, control and laboratory use, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In-vitro diagnostic (IVD) medical equipment; Corrigendum 1 |
| IEC 61326-2-6-2005 | 測量、控制和實(shí)驗(yàn)室用電氣設(shè)備.電磁兼容性要求.第2-6部分:特殊要求.實(shí)驗(yàn)室條件下診斷（IVD)醫(yī)療設(shè)備 | Electrical equipment for measurement, control and laboratory use, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In-vitro diagnostic (IVD) medical equipment |
| IEC 61558-2-15-1999 | 電力變壓器、電源裝置及類似設(shè)備的安全 第2-15部分:醫(yī)療場所供電用隔離變壓器的特殊要求 | Safety of power transformers, power supply units and similar - Part 2-15: Particular requirements for isolating transformers for the supply of medical locations |
| IEC 61676 Edition 1.1-2009 | 醫(yī)療電氣設(shè)備.在放射診斷中X射線管電壓的無傷害性測量用劑量測定儀器 | Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology |
| IEC 62127-1 Corrigendum 1-2008 | 超音波學(xué).水聽器.第1部分:頻率小于40 MHz的醫(yī)療超聲波場的測量和特性.技術(shù)勘誤1 | Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz; Corrigendum 1 |
| IEC 62220-1-2-2007 | 醫(yī)療電氣設(shè)備.數(shù)字X射線成像裝置的特性.第1-2部分:偵探量子效率的測定.X射線測定法用探測器 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
| IEC 62220-1-3-2008 | 醫(yī)療電氣設(shè)備.數(shù)字X射線成像裝置的特性.第1-3部分:探測量子效率的測定.動(dòng)態(tài)成像用探測器 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
| IEC 62274-2005 | 醫(yī)療電氣設(shè)備.放射療法記錄和檢定系統(tǒng)的安全 | Medical electrical equipment - Safety of radiotheraphy record and verify systems |
| IEC 62304-2006 | 醫(yī)療器械用軟件.軟件壽命過程 | Medical device software - Software life cycle processes |
| IEC 62353-2007 | 醫(yī)療電氣設(shè)備.醫(yī)療電氣設(shè)備的循環(huán)試驗(yàn)和維修后試驗(yàn) | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| IEC 62359-2006 | 超聲波.聲場特性.測定與醫(yī)療診斷超聲場相關(guān)的熱和機(jī)械指數(shù)的試驗(yàn)方法 | Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| IEC 62366-2007 | 醫(yī)療設(shè)備.醫(yī)療設(shè)備可用性工程的應(yīng)用 | Medical devices - Application of usability engineering to medical devices |
| IEC 62464-1-2007 | 醫(yī)療成象磁共振設(shè)備.第1部分:測定實(shí)際成象質(zhì)量參數(shù) | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters |
| IEC 62494-1-2008 | 醫(yī)療電氣設(shè)備.數(shù)字X射線成像系統(tǒng)的曝光指數(shù).第1部分:通用X射線照相術(shù)的定義和要求 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definition and requirements of general radiography |
| IEC 62563-1-2009 | 醫(yī)療電氣設(shè)備.醫(yī)學(xué)圖像顯示系統(tǒng).第1部分:評價(jià)方法 | Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods |
| IEC 80601-2-30-2009 | 醫(yī)療電氣設(shè)備.第2-30部分:自動(dòng)非入侵式血壓測量計(jì)的基本安全和基本性能用特殊要求 | Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygnomanometers |
| IEC 80601-2-35-2009 | 醫(yī)療電氣設(shè)備.第2-35部分:應(yīng)用于加熱的毛毯,襯墊或床墊及醫(yī)用加熱裝置基本安全性及基本性能的詳細(xì)規(guī)范 | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| IEC 80601-2-58-2008 | 醫(yī)療電氣設(shè)備.第2-58部分:眼科手術(shù)用晶狀體移除裝置和玻璃體切除裝置基本安全和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 devices for ophthalmic surgery |
| IEC 80601-2-59 Corrigendum 1-2009 | 醫(yī)療電氣設(shè)備.第2-59部分:人類發(fā)熱檢查用檢查溫度記錄儀的基本安全和基本性能用特殊要求 | Medical electrical equipment - Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening; Corrigendum 1 |
| IEC 80601-2-59-2008 | 醫(yī)療電氣設(shè)備.第2-59部分:人類發(fā)熱檢查用檢查溫度記錄儀的基本安全和基本性能用特殊要求 | Medical electrical equipment - Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening |
| IEC/PAS 61910-1-2007 | 醫(yī)療用電氣設(shè)備.輻照劑量文件.第1部分:射線照相和射線透視用設(shè)備 | Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy |
| IEC/TR 60788-2004 | 醫(yī)療電氣設(shè)備.定義的術(shù)語匯編 | Medical electrical equipment - Glossary of defined terms |
| IEC/TR 60878-2003 | 醫(yī)療規(guī)程中電氣設(shè)備的圖形符號 | Graphical symbols for electrical equipment in medical practice |
| IEC/TR 60930-2008 | 管理、醫(yī)療、護(hù)理人員安全使用醫(yī)療電氣設(shè)備和醫(yī)療電氣系統(tǒng)用指南 | Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems |
| IEC/TR 61258-2008 | 醫(yī)療電氣設(shè)備教材的開發(fā)和使用指南 | Guidelines for the development and use of medical electrical equipment educational materials |
| IEC/TR 61948-1-2001 | 核醫(yī)療設(shè)備 常規(guī)試驗(yàn) 第1部分：輻射計(jì)數(shù)系統(tǒng) | Nuclear medicine instrumentation - Routine tests - Part 1: Radiation counting systems |
| IEC/TR 61948-2-2001 | 核醫(yī)療設(shè)備 常規(guī)試驗(yàn) 第2部分：閃爍照相機(jī)與單光子發(fā)射計(jì)算機(jī)子X射線斷層成像 | Nuclear medicine instrumentation - Routine tests - Part 2: Scintillation cameras and single photon emission computed tomography imaging |
| IEC/TR 61948-3-2005 | 核醫(yī)療設(shè)備.常規(guī)試驗(yàn).第3部分:正電子放射斷層攝影 | Nuclear medicine instrumentation - Routine tests - Part 3: Positron emission tomographs |
| IEC/TR 61948-4-2006 | 核醫(yī)療設(shè)備.常規(guī)試驗(yàn).第4部分:放射性核素校準(zhǔn)器 | Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators |
| IEC/TR 62266-2002 | 醫(yī)療電氣設(shè)備.放射療法中DICOM的實(shí)現(xiàn)指南 | Medical electrical equipment - Guidelines for implementation of DICOM in radiotherapy |
| IEC/TR 62354-2009 | 醫(yī)療電氣設(shè)備的一般試驗(yàn)規(guī)程 | General testing procedures for medical electrical equipment |
| IEC/TR 80002-1-2009 | 醫(yī)療設(shè)備軟件.第1部分:用于醫(yī)療設(shè)備軟件的ISO 14971 應(yīng)用指南 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| ISO 10079-1-1999 | 醫(yī)療吸引設(shè)備 第1部分:電動(dòng)吸引設(shè)備 安全要求 | Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements |
| ISO 10079-2-1999 | 醫(yī)療吸引設(shè)備 第2部分:手動(dòng)吸引設(shè)備 | Medical suction equipment - Part 2: Manually powered suction equipment |
| ISO 10079-3-1999 | 醫(yī)療吸引設(shè)備 第3部分:真空或用壓力驅(qū)動(dòng)吸引設(shè)備 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source |
| ISO 10524-4-2008 | 醫(yī)療氣體用壓力調(diào)節(jié)器.第4部分:低壓調(diào)節(jié)器 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators |
| ISO 10993-1 Technical Corrigendum 1-2010 | 醫(yī)療器械的生物評定.第1部分:風(fēng)險(xiǎn)管理過程內(nèi)的試驗(yàn)和評定.技術(shù)勘誤表1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Technical Corrigendum 1 |
| ISO 10993-1-2009 | 醫(yī)療器械的生物學(xué)評價(jià).第1部分:在風(fēng)險(xiǎn)管理過程內(nèi)的評價(jià)與試驗(yàn) | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ISO 10993-10 AMD 1-2006 | 醫(yī)療器械的生物評定.第10部分:刺激與持續(xù)型過敏癥試驗(yàn) | Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity; Amendment 1 |
| ISO 10993-10-2002 | 醫(yī)療器械的生物評定.第10部分:刺激與持續(xù)型過敏癥試驗(yàn) | Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity |
| ISO 10993-11-2006 | 醫(yī)療器械的生物學(xué)評價(jià).第11部分:身體組織毒性試驗(yàn) | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| ISO 10993-12-2007 | 醫(yī)療器械的生物學(xué)評估.第12部分:樣品制備和參考材料 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| ISO 10993-13-2010 | 醫(yī)療器械的生物學(xué)評價(jià).第13部分:聚合物醫(yī)療器械降解產(chǎn)物的鑒定與定量 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10993-14-2001 | 醫(yī)療器械的生物學(xué)評價(jià) 第14部分：陶瓷降解產(chǎn)物的識別和量化 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-15-2000 | 醫(yī)療器械的生物學(xué)評價(jià) 第15部分:金屬與合金降解產(chǎn)物的識別與定性 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys |
| ISO 10993-16-2010 | 醫(yī)療器械的生物學(xué)評估.第16部分:降解產(chǎn)物和可濾取物的毒物動(dòng)力學(xué)研究設(shè)計(jì) | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO 10993-17-2002 | 醫(yī)療器械的生物評定.第17部分:可浸出物質(zhì)容許限值的確定 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-18-2005 | 醫(yī)療器械的生物學(xué)評價(jià).第18部分:材料的化學(xué)特性 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials |
| ISO 10993-2-2006 | 醫(yī)療器械的生物學(xué)評價(jià).第2部分:動(dòng)物保護(hù)要求 | Biological evaluation of medical devices - Part 2: Animal welfare requirements |
| ISO 10993-3-2003 | 醫(yī)療器械的生物評定.第3部分:遺傳毒性、致癌性和生殖毒性的試驗(yàn) | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4 AMD 1-2006 | 醫(yī)療器械的生物評定.第4部分:與血液相互作用的選擇試驗(yàn) | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood |
| 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(yàn)的選擇 | Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood |
| ISO 10993-5-2009 | 醫(yī)療器械的生物學(xué)評價(jià).第5部分:體外細(xì)胞毒性試驗(yàn) | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-7 Technical Corrigendum 1-2009 | 醫(yī)療器械的生物學(xué)評價(jià).第7部分:環(huán)氧乙烷滅菌殘留物.勘誤表1 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1 |
| ISO 10993-7-2008 | 醫(yī)療器械的生物學(xué)評價(jià) 第7部分:環(huán)氧乙烷滅菌殘留量 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals |
| ISO 11073-90101-2008 | 健康信息學(xué).床旁監(jiān)護(hù)用醫(yī)療裝置通信.第90101部分:分析儀器.床旁監(jiān)護(hù)試驗(yàn) | Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments - Point-of-care test |
| 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)備消毒過程的制定、確認(rèn)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 |
| ISO 11137-1-2006 | 保健產(chǎn)品的滅菌.輻射.第1部分:醫(yī)療器件消毒過程的制定、確認(rèn)、和常規(guī)控制的要求 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11138-1-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物.第1部分:一般要求 | Sterilization of health care products - Biological indicators - Part 1: General requirements |
| ISO 11138-2-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物.第2部分:環(huán)氧乙烷滅菌同生物指示劑 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 11138-3-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物.第3部分:濕熱滅菌用生物指示劑 | Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes |
| 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 |
| ISO 11138-5-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示器.第5部分:低溫蒸汽和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 |
| ISO 11737-1 Technical Corrigendum 1-2007 | 醫(yī)療設(shè)備滅菌.微生物法.第1部分:產(chǎn)品上微生物群落的測定.技術(shù)勘誤1 | Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products; Technical Corrigendum 1 |
| ISO 11737-1-2006 | 醫(yī)療器械滅菌.微生物學(xué)方法.第1部分:產(chǎn)品上微生物群落的測定 | Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products |
| ISO 11737-2-2009 | 醫(yī)療器械滅菌.微生物學(xué)方法.第2部分:滅菌過程的定義、有效性和維護(hù)中進(jìn)行的無菌試驗(yàn) | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 12894-2001 | 熱環(huán)境的人類工效學(xué) 對暴露在極熱或極冷環(huán)境的人的醫(yī)療監(jiān)督 | Ergonomics of the thermal environment - Medical supervision of individuals exposed to extreme hot or cold environments |
| ISO 13408-1-2008 | 醫(yī)療保健產(chǎn)品的無菌加工.第1部分:一般要求 | Aseptic processing of health care products - Part 1: General requirements |
| 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 |
| ISO 13485 Technical Corrigendum 1-2009 | 醫(yī)療器械.質(zhì)量管理體系.管理用途的要求,技術(shù)勘誤表1 | Medical devices - Quality management systems - Requirements for regulatory purposes; Technical Corrigendum 1 |
| ISO 13485-2003 | 醫(yī)療器械.質(zhì)量管理系統(tǒng).管理目標(biāo)的要求 | Medical devices - Quality management systems - Requirements for regulatory purposes |
| ISO 13606-1-2008 | 醫(yī)療信息學(xué).電子健康記錄信息.第1部分:參考模型 | Health informatics - Electronic health record communication - Part 1: Reference model |
| ISO 13606-2-2008 | 醫(yī)療信息學(xué).電子健康記錄信息.第2部分:原型交換規(guī)范 | Health informatics - Electronic health record communication - Part 2: Archetype interchange specification |
| ISO 13606-3-2009 | 醫(yī)療信息學(xué).電子健康記錄通信.第3部分:參考原型和術(shù)語清單 | Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists |
| ISO 13606-5-2010 | 醫(yī)療信息學(xué).電子健康記錄通信.第5部分:接口規(guī)范 | Health informatics - Electronic health record communication - Part 5: Interface specification |
| ISO 14155-1-2003 | 人用醫(yī)療設(shè)備的臨床調(diào)查.第1部分:一般要求 | Clinical investigation of medical devices for human subjects - Part 1: General requirements |
| ISO 14155-2-2003 | 醫(yī)學(xué)受驗(yàn)者用醫(yī)療器械的臨床調(diào)查.第2部分:臨床調(diào)查設(shè)備 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants |
| ISO 14160-1998 | 使用液體化學(xué)滅菌劑對包括動(dòng)物源材料在內(nèi)的一次性使用醫(yī)療器具進(jìn)行滅菌的確認(rèn)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 sterilants |
| ISO 14161-2009 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物選擇,使用及檢驗(yàn)結(jié)果判斷指南 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
| ISO 14708-1-2000 | 外科植入物.有源可植入醫(yī)療裝置.第1部分:安全、標(biāo)記及制造商提供信息的一般要求 | Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| ISO 14708-2-2005 | 外科植入物.有源可植入醫(yī)療裝置.第2部分:心臟起搏器 | Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers |
| ISO 14708-4-2008 | 外科植入物.有源可植入醫(yī)療裝置.第4部分:可植入輸注管 | Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps |
| 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 |
| ISO 14708-6-2010 | 外科植入物.有源可植入醫(yī)療裝置.第6部分:用于治療快速性心律失常(包括可植入去纖顫器)有源植入式醫(yī)療器件的 | Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
| ISO 14937-2009 | 保健產(chǎn)品滅菌.醫(yī)療器械用消毒劑的特性和消毒方法的研發(fā),驗(yàn)證及常規(guī)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 |
| ISO 14971-2007 | 醫(yī)療裝置.醫(yī)療裝置風(fēng)險(xiǎn)管理的應(yīng)用 | Medical devices - Application of risk management to medical devices |
| ISO 15002-2008 | 醫(yī)療氣體管道系統(tǒng)連接到終端裝置用流量計(jì)測量裝置 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| ISO 15193-2009 | 體外診斷醫(yī)療器械.生物起源樣品中數(shù)量的測量.內(nèi)容要求和參考測量法的說明 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures |
| ISO 15194-2009 | 體外診斷醫(yī)療設(shè)備.生物原始試樣數(shù)量測量.認(rèn)證參考材料和證明文件的內(nèi)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 |
| ISO 15198-2004 | 臨床實(shí)驗(yàn)室藥物.體外診斷醫(yī)療設(shè)備.由制造商證實(shí)的用戶質(zhì)量控制程序 | Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer |
| ISO 15223 AMD 1-2002 | 醫(yī)療裝置.與醫(yī)療裝置標(biāo)簽、加標(biāo)簽和提供的信息一起使用的符號.修改件1 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 1 |
| ISO 15223 AMD 2-2004 | 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.修改件2 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2 |
| ISO 15223-1 AMD 1-2008 | 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.第1部分:一般要求.修改件1 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements; Amendment 1 |
| ISO 15223-1-2007 | 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 |
| 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 |
| ISO 15225-2010 | 醫(yī)療設(shè)備.質(zhì)量管理.醫(yī)療設(shè)備命名法數(shù)據(jù)結(jié)構(gòu) | Medical devices - Quality management - Medical device nomenclature data structure |
| ISO 16428-2005 | 外科植入物.可植入物質(zhì)和醫(yī)療器械的靜態(tài)和動(dòng)態(tài)腐蝕試驗(yàn)用試驗(yàn)溶液和環(huán)境條件 | Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices |
| ISO 16429-2004 | 外科植入物.金屬可植入材料和長期醫(yī)療器械的評估腐蝕性能用斷路電位的測量 | Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods |
| ISO 17090-1-2008 | 醫(yī)療信息學(xué).公開密鑰基礎(chǔ)設(shè)施.第1部分:數(shù)字證書業(yè)務(wù)綜述 | Health informatics - Public key infrastructure - Part 1: Overview of digital certificate services |
| ISO 17090-3-2008 | 醫(yī)療信息學(xué).公開密鑰基礎(chǔ)設(shè)施.第3部分:認(rèn)證管理機(jī)構(gòu)的政策管理 | Health informatics - Public key infrastructure - Part 3: Policy management of certification authority |
| ISO 17511-2003 | 體外診斷醫(yī)療裝置.生物試樣的定量測量.校準(zhǔn)儀和控制材料賦值的計(jì)量溯源性 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials |
| ISO 17593-2007 | 臨床實(shí)驗(yàn)室測試和體外醫(yī)療裝置.口服抗凝血?jiǎng)┲委熥詼y用體外監(jiān)測系統(tǒng)的要求 | Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| ISO 17664-2004 | 醫(yī)療器械的消毒.生產(chǎn)商提供的可重復(fù)消毒醫(yī)療器械的處理信息 | Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices |
| ISO 17665-1-2006 | 保健產(chǎn)品的滅菌.濕熱.第1部分:醫(yī)療機(jī)械消毒過程的制定、確認(rèn)和常規(guī)控制的要求 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 18104-2003 | 醫(yī)療信息.護(hù)理用參考術(shù)語模式的綜合 | Health informatics - Integration of a reference terminology model for nursing |
| ISO 18113-1-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標(biāo)簽).第1部分:術(shù)語、定義和一般要求 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements |
| ISO 18113-2-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標(biāo)簽).第2部分:專業(yè)用途的體外診斷試劑 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use |
| ISO 18113-3-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標(biāo)簽).第3部分:專業(yè)用體外診斷儀器 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use |
| ISO 18113-4-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標(biāo)簽).第4部分:自測用體外診斷劑 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing |
| ISO 18113-5-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標(biāo)簽).第5部分:自測用體外診斷儀器 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing |
| ISO 18153-2003 | 體外診斷醫(yī)療裝置.生物樣品的定量測量.校準(zhǔn)儀和控制材料所賦酶的催化濃度值的計(jì)量溯源性 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials |
| ISO 18779-2005 | 儲存氧氣和氧氣混合物的醫(yī)療設(shè)備.特殊要求 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements |
| ISO 18812-2003 | 醫(yī)療信息學(xué).醫(yī)用分析儀與實(shí)驗(yàn)室信息系統(tǒng)的接口.使用說明文件 | Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles |
| ISO 19001-2002 | 實(shí)驗(yàn)室診斷醫(yī)療設(shè)備.生物著色用實(shí)驗(yàn)室診斷試劑生產(chǎn)廠商提供的信息 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| ISO 19054-2005 | 醫(yī)療設(shè)備輔助用軌道系統(tǒng) | Rail systems for supporting medical equipment |
| ISO 21171-2006 | 醫(yī)療專用手套.可移動(dòng)表面粉末的測定 | Medical gloves - Determination of removable surface powder |
| ISO 21549-5-2008 | 醫(yī)療信息學(xué).病人醫(yī)療卡數(shù)據(jù).第5部分:識別數(shù)據(jù) | Health informatics - Patient healthcard data - Part 5: Identification data |
| ISO 21549-6-2008 | 醫(yī)療信息學(xué).病人醫(yī)療卡數(shù)據(jù).第6部分:管理數(shù)據(jù) | Health informatics - Patient healthcard data - Part 6: Administrative data |
| ISO 21647 Technical Corrigendum 1-2005 | 醫(yī)療電氣設(shè)備.呼吸氣監(jiān)測器的基本安全和主要性能的特殊要求.技術(shù)勘誤1 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors; Technical Corrigendum 1 |
| ISO 21647-2004 | 醫(yī)療電氣設(shè)備.呼吸氣監(jiān)測器的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 respiratory gas monitors |
| ISO 21969-2009 | 與醫(yī)療氣體系統(tǒng)一起使用的高壓柔性連接 | High-pressure flexible connections for use with medical gas systems |
| ISO 22442-1-2007 | 醫(yī)療設(shè)備用動(dòng)物組織及其衍生物.第1部分:風(fēng)險(xiǎn)管理的應(yīng)用 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| ISO 22442-2-2007 | 醫(yī)療設(shè)備用動(dòng)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 |
| ISO 22442-3-2007 | 醫(yī)療設(shè)備用動(dòng)物組織及其衍生物.第3部分:病毒和傳染性海綿狀腦病(TSE)試劑的銷毀和/或失效的確認(rèn) | 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 |
| ISO 22609-2004 | 傳染試劑防護(hù)服.醫(yī)療面罩.防人造血滲透的試驗(yàn)方法(固定容積,水平噴射) | Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) |
| ISO 25424-2009 | 醫(yī)療器械的消毒.低溫蒸汽和甲醛.醫(yī)療器械消毒工序的制訂,認(rèn)證和日常控制要求 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 27186-2010 | 有源可植入醫(yī)療器械.可植入心節(jié)律管理裝置用四極連接器系統(tǒng).尺寸和試驗(yàn)要求 | Space systems - Programme management - Quality assurance requirements |
| ISO 28620-2010 | 醫(yī)療設(shè)備.非電驅(qū)動(dòng)的便攜式輸液設(shè)備 | Medical devices - Non-electrically driven portable infusion devices |
| ISO 594-1-1986 | 注射器、針頭及其他醫(yī)療器械為6%(魯爾)的錐形接頭 第1部分:一般要求 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements |
| ISO 594-2-1998 | 注射器、針頭及其他醫(yī)療器械為6%(魯爾)的錐形接頭 第2部分:鎖緊接頭 | Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings |
| ISO 7396-1 AMD 1-2010 | 醫(yī)用氣體管道系統(tǒng).第1部分:壓縮的醫(yī)用氣體和真空用管道系統(tǒng).修改件1:裝配于操作者可調(diào)部件醫(yī)療補(bǔ)給裝置和連 | Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 1: Requirements for terminal units for vacuum fitted on medical supply units with operator-adjustable portions and connected to the pipeline through flexible hoses |
| ISO 7405-2008 | 牙科學(xué).牙科醫(yī)療器械生物相容性評估 | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| ISO 80601-2-56-2009 | 醫(yī)療電氣設(shè)備.第2-56部分:人體體溫測量用體溫計(jì)的基本安全和主要性能的特殊要求 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
| ISO 8600-2-2002 | 光學(xué)和光學(xué)儀器.醫(yī)療內(nèi)窺鏡和內(nèi)窺鏡附件.第2部分:硬支氣管內(nèi)窺鏡的特殊要求 | Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 2: Particular requirements for rigid bronchoscopes |
| ISO 9626 AMD 1-2001 | 供制造醫(yī)療器械用的不銹鋼針管 修改1 | Stainless steel needle tubing for the manufacture of medical devices; Amendment 1 |
| ISO 9626-1991 | 供制造醫(yī)療器械用的不銹鋼針管 | Stainless steel needle tubing for manufacture of medical devices |
| ISO/HL7 27931-2009 | 數(shù)據(jù)交換標(biāo)準(zhǔn).HL7標(biāo)準(zhǔn)2.5版本.在醫(yī)療環(huán)境下電子數(shù)據(jù)交換的應(yīng)用協(xié)議 | Data Exchange Standards - Health Level Seven Version 2.5 - An application protocol for electronic data exchange in healthcare environments |
| ISO/IEC Guide 63-1999 | 醫(yī)療器械安全方面的開發(fā)并納入國際標(biāo)準(zhǔn)指南 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| ISO/IEEE 11073-10101-2004 | 健康信息學(xué).床旁檢測醫(yī)療設(shè)備通信.第10101部分:術(shù)語 | Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature |
| ISO/IEEE 11073-10201-2004 | 健康信息學(xué).床旁檢測醫(yī)療設(shè)備通信.第10201部分:域信息模式 | Health informatics - Point-of-care medical device communication - Part 10201: Domain information model |
| ISO/IEEE 11073-10471-2010 | 保健信息學(xué).床邊體外診斷(POC)醫(yī)療設(shè)備通信.第10471部分:設(shè)備規(guī)范.獨(dú)立的現(xiàn)場動(dòng)態(tài)指示器集線器 | Health informatics - Point-of-care medical device communication - Part 10471: Device specialization - Independant living activity hub |
| ISO/IEEE 11073-20101-2004 | 健康信息學(xué).床旁檢測醫(yī)療設(shè)備通信.第20101部分:應(yīng)用輪廓.基本標(biāo)準(zhǔn) | Health informatics - Point-of care medical device communications - Part 20101: Application profiles; Base standard |
| ISO/IEEE 11073-30200-2004 | 健康信息學(xué).床旁檢測醫(yī)療設(shè)備通信.第30200部分:傳輸輪廓.電纜連接 | Health informatics - Point-of-care medical device communications - Part 30200: Transport profile; Cable connected |
| ISO/IEEE 11073-30300-2004 | 健康信息學(xué).床旁檢測醫(yī)療設(shè)備通信.第30300部分:傳輸輪廓.紅外無線 | Health informatics - Point-of-care medical device communications - Part 30300: Transport profile; Infrared wireless |
| ISO/TR 11633-1-2009 | 衛(wèi)生信息學(xué).醫(yī)療設(shè)備及醫(yī)療信息系統(tǒng)的遠(yuǎn)程維護(hù)用信息安全管理.第1部分:要求和風(fēng)險(xiǎn)分析 | Health informatics - Information security management for remote maintenance of medical devices and medical information systems - Part 1: Requirements and risk analysis |
| ISO/TR 13154-2009 | 醫(yī)療電氣設(shè)備.篩選溫度計(jì)用鑒定發(fā)熱人群用部署、實(shí)施和操作指南 | Medical electrical equipment - Deployment, implementation and operational guidelines for indentifying febrile humans using a screening thermograph |
| ISO/TR 14969-2004 | 醫(yī)療裝置.質(zhì)量管理系統(tǒng).ISO 13485-2003應(yīng)用指南 | Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003 |
| ISO/TR 16056-1-2004 | 醫(yī)療信息學(xué).遠(yuǎn)程醫(yī)療系統(tǒng)和網(wǎng)絡(luò)的交替使用性.第1部分:介紹和定義 | Health informatics - Interoperability of telehealth systems and networks - Part 1: Introduction and definitions |
| ISO/TR 16056-2-2004 | 醫(yī)療信息學(xué).遠(yuǎn)程醫(yī)療系統(tǒng)和網(wǎng)絡(luò)的交替使用性.第2部分:實(shí)時(shí)系統(tǒng) | Health informatics - Interoperability of telehealth systems and networks - Part 2: Real-time systems |
| ISO/TR 16142-2006 | 醫(yī)療器械.醫(yī)療器械安全和性能公認(rèn)基本原則的配套標(biāo)準(zhǔn)選用指南 | Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO/TR 21089-2004 | 醫(yī)療信息學(xué).可信端到端信息流 | Health informatics - Trusted end-to-end information flows |
| ISO/TR 21730-2007 | 醫(yī)療信息.保健設(shè)施中移動(dòng)無線通信和計(jì)算技術(shù)應(yīng)用.推薦關(guān)于醫(yī)療設(shè)備電磁兼容性應(yīng)用(被動(dòng)電磁兼容性干擾管理) | Health informatics - Use of mobile wireless communication and computing technology in healthcare facilities - Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices |
| ISO/TR 25257-2009 | 健康信息學(xué).醫(yī)療產(chǎn)品國際代碼系統(tǒng)的業(yè)務(wù)要求 | Health informatics - Business requirements for an international coding system for medicinal products |
| ISO/TS 10993-19-2006 | 醫(yī)療設(shè)備的生物評定.第19部分:材料的物理化學(xué)、形態(tài)學(xué)和地形學(xué)特點(diǎn) | Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials |
| ISO/TS 10993-20-2006 | 醫(yī)療設(shè)備的生物評定.第20部分:醫(yī)療設(shè)備的免疫毒物學(xué)試驗(yàn)的原則和方法 | Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ISO/TS 11073-92001-2007 | 健康信息學(xué).醫(yī)療波形格式.第92001部分:編碼規(guī)則 | Health informatics - Medical waveform format - Part 92001: Encoding rules |
| ISO/TS 16058-2004 | 醫(yī)療信息學(xué).遠(yuǎn)程學(xué)習(xí)系統(tǒng)的交替使用性 | Health informatics - Interoperability of telelearning systems |
| ISO/TS 18308-2004 | 醫(yī)療信息學(xué).電子病歷體系結(jié)構(gòu)要求 | Health informatics - Requirements for an electronic health record architecture |
| ISO/TS 19218-2005 | 醫(yī)療設(shè)備.不良反應(yīng)的類型和起因的編碼體系 | Medical devices - Coding structure for adverse event type and cause |
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