| 編號 | 中文名稱 | 英文名稱 |
|---|---|---|
| BIP 2071-2005 | 醫(yī)療器械:ISO 13485和ISO 9001 | Medical devices: ISO 13485 and ISO 9001 |
| BIP 3083-2009 | 醫(yī)療裝置CD-ROM的標記用圖形符號 | Graphical symbols for use in the labelling of medical devices CD-ROM |
| BS 2606-1955 | 峰值達150kV的醫(yī)療診斷用X射線防護手套規(guī)范 | Specification for X-ray protective gloves for medical diagnostic purposes up to 150 kV peak |
| BS 3043-1973 | 醫(yī)療放射照相已沖洗的X射線膠片的儲存袋規(guī)范 | Specification for storage envelopes for processed X-ray films for medical radiography |
| BS 3970-2-1991 | 醫(yī)療制品滅菌消毒設備.第2部分:含水液體密封硬質(zhì)容器用蒸汽消毒器規(guī)范 | Sterilizing and disinfecting equipment for medical products - Specification for steam sterilizers for aqueous fluids in sealed rigid containers |
| BS 3970-5-1990 | 醫(yī)療制品滅菌消毒設備.第5部分:低溫蒸汽消毒器規(guī)范 | Sterilizing and disinfecting equipment for medical products - Specification for low temperature steam disinfectors |
| BS 4727-5 Group 01-1985 | 電工、電力、電信、電子學、照明和顏色術語.第5部分:醫(yī)療電氣設備專用術語.第01集:輻射學和輻射物理學術語 | Glossary of electrotechnical, power, telecommunication, electronics, lighting and colour terms - Terms particular to electromedical equipment - Radiology and radiological physics terminology |
| BS 5682-1998 | 醫(yī)療用燃氣管道系統(tǒng)探測頭(快速連接器)規(guī)范 | Specification for probes (quick connectors) for use with medical gas pipeline systems |
| BS 6058-1989 | 醫(yī)療診斷用旋轉(zhuǎn)陽極X射線管和X射線管組件的規(guī)定和檢驗方法 | Method of specifying and verifying the characteristics of rotating anode X-ray tubes and X-ray tube assemblies used in medical diagnosis |
| BS 7634-1993 | 醫(yī)療用氣體管道系統(tǒng)用氧化濃縮器規(guī)范 | Specification for oxygen concentrators for use with medical gas pipeline systems |
| BS 7725-2.1-1994 | 醫(yī)療成像科評估和常規(guī)試驗.第2部分:穩(wěn)定性試驗.第1節(jié):洗片機方法 | Evaluation and routine testing in medical imaging departments - Constancy tests - Method for film processors |
| BS 7725-2.2-1994 | 醫(yī)療成像科評估和常規(guī)試驗.第2部分:穩(wěn)定性試驗.第2節(jié):屏蔽暗盒組件的X射線暗盒、換片器、膠片屏蔽觸點和相 | Evaluation and routine testing in medical imaging departments - Constancy tests - Method for radiographic cassettes and film changers and film-screen contact and relative sensitivity of the screen-cassette assembly |
| BS 7725-2.3-1994 | 醫(yī)療成像科評估和常規(guī)試驗.穩(wěn)定性試驗.暗室安全燈條件方法 | Evaluation and routine testing in medical imaging departments - Constancy tests - Method for darkroom safelight conditions |
| BS 8421-1-2003 | 醫(yī)療衛(wèi)生信息學指南.健康護理的結果.傳遞給最終用戶.通用指南和推薦規(guī)范 | Guide to health informatics - Results of healthcare service procedures - Delivery to end-users - General guidance and recommendations |
| BS 8441-2-2006 | 健康信息學.醫(yī)療數(shù)字成像輪廓.M-IHE6-4.8MIS-CT"CT存儲的圖像 | Health informatics - Medical digital imaging profiles - ?M-IHE6-4.8MIS-CT? CT images stored |
| BS 8480-2006 | 醫(yī)療裝置.帶電力驅(qū)動支持表面的椅子.要求 | Medical devices - Chairs with electrically operated support surfaces - Requirements |
| BS 8497-1-2008 | 遮掩和醫(yī)療設施用人類和動物防強光源的防目鏡.產(chǎn)品規(guī)范 | Eyewear for protectionagainst intense lightsources used on humansand animals for cosmeticand medicalapplications –Part 1: Specification for products |
| BS 8497-2-2008 | 遮掩和醫(yī)療設施用人類和動物防強光源的防目鏡.使用指南 | Eyewear for protectionagainst intense lightsources used on humansand animals forcosmetic and medicalapplicationsPart 2: Guidance on use |
| BS DD CEN/TS 14271-2003 | 醫(yī)療信息學.重要標記的文件交換格式 | Health informatics - File exchange format for vital signs |
| BS DD CEN/TS 14796-2004 | 醫(yī)療信息學.數(shù)據(jù)類型 | Health informatics - Data types |
| BS DD ENV 12018-1998 | 醫(yī)療保健使用的斷續(xù)連接裝置的識別、認可和公共門診數(shù)據(jù)結構(包括可機讀的卡） | Identification, administrative, and common clinical data structure for intermittently connected devices used in healthcare (including machine readable cards) |
| BS DD ENV 12443-2001 | 醫(yī)療信息.醫(yī)療保健信息框架(HIF) | Medical informatics - Healthcare information framework (HIF) |
| BS DD ENV 12537-1-1998 | 醫(yī)療信息學.醫(yī)療保健EDI 用信息客體登記.登記員 | Medical informatics - Registration of information objects used for EDI in healthcare - The register |
| BS DD ENV 12537-2-1998 | 醫(yī)療信息學.醫(yī)療保健 EDI用信息客體登記.醫(yī)療保健電子信息交換(EDI)使用的信息客體注冊的程序 | Medical informatics - Registration of information objects used for EDI in healthcare - Procedures for the registration of information objects used in electronic data interchange (EDI) in healthcare |
| BS DD ENV 12538-1998 | 醫(yī)療信息學.患者診療安排和出院的信息 | Medical informatics - Messages for patient referral and discharge |
| BS DD ENV 12539-1998 | 醫(yī)療信息學.診斷業(yè)務部門的要求和報告文電 | Medical informatics - Request and report messages for diagnostic service departments |
| BS DD ENV 12610-1998 | 醫(yī)療信息學.醫(yī)用產(chǎn)品標識 | Medical informatics - Medical product identification |
| BS DD ENV 12611-1998 | 醫(yī)療信息學.概念系統(tǒng)的編目結構.醫(yī)療裝置 | Medical informatics - Categorical structure of systems of concepts - Medical devices |
| BS DD ENV 12612-1998 | 醫(yī)療信息學.醫(yī)療保健管理信息交換的文電 | Medical informatics - Messages for the exchange of healthcare administrative information |
| BS DD ENV 12924-1998 | 醫(yī)療信息學.醫(yī)療保健信息系統(tǒng)的安全性采編和保護 | Medical informatics - Security categorisation and protection for healthcare information systems |
| BS DD ENV 13607-2000 | 醫(yī)療保健信息學.醫(yī)藥處方信息交換用的電文 | Health informatics - Messages for the exchange of information on medicine prescriptions |
| BS DD ENV 13608-1-2000 | 醫(yī)療保健信息學.保健通信的安全性.概念和術語 | Health informatics - Security for healthcare communication - Concepts and terminology |
| BS DD ENV 13608-2-2000 | 醫(yī)療保健信息學.保健通信的安全性.安全數(shù)據(jù)對象 | Health informatics - Security for healthcare communication - Secure data objects |
| BS DD ENV 13608-3-2000 | 醫(yī)療保健信息學.保健通信的安全性.安全數(shù)據(jù)通道 | Health informatics - Security for healthcare communication - Secure data channels |
| BS DD ENV 13609-2-2000 | 醫(yī)療保健信息學.保健系統(tǒng)中支持信息的維護電文.醫(yī)學實驗室專用信息的更新 | Healthcare informatics - Messages for maintenance of supporting information in healthcare systems - Updating of medical laboratory-specific information |
| BS DD ENV 13729-2000 | 醫(yī)療衛(wèi)生信息學.安全用戶識別.強鑒別能力微處理機識別卡 | Health informatics - Secure user identification - Strong authentication microprocessor cards |
| BS DD ENV 13735-2001 | 醫(yī)療衛(wèi)生信息.與病人連接的醫(yī)療裝置的互操作性 | Health informatics - Interoperability of patient connected medical devices |
| BS DD ENV 1613-1996 | 醫(yī)療信息學.實驗室信息交換的文電 | Medical informatics - Messages for exchange of laboratory information |
| BS DD ISO/TS 10993-19-2006 | 醫(yī)療設備的生物評定.材料的物理-化學、形態(tài)學和地形學特征 | Biological evaluation of medical devices - Physico-chemical, morphological and topographical characterization of materials |
| BS DD ISO/TS 10993-20-2006 | 醫(yī)療設備的生物評定.醫(yī)療設備的免疫毒物學試驗的原則和方法 | Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices |
| BS DD ISO/TS 11073-92001-2007 | 健康信息學.醫(yī)療波形格式.編碼規(guī)則 | Health informatics - Medical waveform format - Encoding rules |
| BS DD ISO/TS 18308-2004 | 醫(yī)療信息學.電子醫(yī)療記錄結構要求 | Health informatics - Requirements for an electronic health record architecture |
| BS DD ISO/TS 19218-2005 | 醫(yī)療設備.不良反應的類型和起因的編碼體系 | Medical devices - Coding structure for adverse event type and cause |
| BS DD ISO/TS 21667-2004 | 醫(yī)療健康信息學.健康指示器概念框架 | Health informatics - Health indicators conceptual framework |
| BS DD ISO/TS 22220-2009 | 健康信息.醫(yī)療保健主題的識別 | Health informatics - Identification of subjects of health care |
| BS EN 1041-1998 | 由廠商提供的醫(yī)療設備信息 | Information supplied by the manufacturer with medical devices |
| BS EN 1041-2008 | 醫(yī)療裝置廠商提供的信息 | Information supplied by the manufacturer of medical devices |
| BS EN 12322-1999 | 體外診斷醫(yī)療裝置.微生物培養(yǎng)基.培養(yǎng)基性能標準 | In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
| BS EN 12376-1999 | 體外診斷醫(yī)療裝置.生物斑漬體外診斷劑發(fā)生器提供的信息 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| BS EN 12967-1-2007 | 醫(yī)療信息學.服務體系機構.企業(yè)觀點 | Health informatics - Service architecture - Enterprise viewpoint |
| BS EN 12967-3-2007 | 醫(yī)療信息學.服務體系機構.計算觀點 | Health informatics - Service architecture - Computational viewpoint |
| BS EN 13532-2002 | 自測試用的體外診斷醫(yī)療裝置的一般要求 | General requirements for in vitro diagnostic medical devices for self-testing |
| BS EN 13609-1-2005 | 健康信息學.醫(yī)療保健系統(tǒng)支持信息維護用消息.編碼方案的更新 | Health informatics - Messages for maintenance of supporting information in healthcare systems - Updating of coding schemes |
| BS EN 13612-2002 | 體外診斷醫(yī)療裝置的性能評估 | Performance evaluation of in vitro diagnostic medical devices |
| BS EN 13624-2003 | 化學消毒劑與防腐劑.醫(yī)療器械用化學消毒劑殺真菌能力評價用定量懸浮液試驗.試驗方法和要求(第2階段第1步) | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1) |
| BS EN 13718-1-2008 | 醫(yī)療車輛及其設備.空中救護機.用于空中救護機的醫(yī)療裝置要求 | Medical vehicles and their equipment - Part 1:Air ambulances - Requirements for medical devices used in air ambulances |
| BS EN 13718-2-2008 | 醫(yī)療車輛及其設備.空中救護機.空中救護機的操作和技術要求 | Medical vehicles and their equipment - Part 2:Air ambulances - Operational and technical requirements of air ambulances |
| BS EN 13727-2003 | 化學消毒劑和防腐劑.醫(yī)療器械用化學消毒劑殺菌活性評價的定量懸浮試驗.試驗方法和要求(第2階段/第1步) | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (Phase 2/Step 1) |
| BS EN 13795-1-2002+A1-2009 | 用作醫(yī)療器械的患者,醫(yī)護人員和醫(yī)療器械用覆蓋巾,手術服和清潔空氣套裝.制造商,處理裝置和產(chǎn)品的一般要求 | Surgical drapes, gownsand clean air suits, usedas medical devices, forpatients, clinical staffand equipment —Part 1: General requirements formanufacturers, processors andproducts |
| BS EN 13795-2-2004+A1-2009 | 用作醫(yī)療器械的患者,醫(yī)護人員和醫(yī)療器械用覆蓋巾,手術服和清潔空氣套裝.試驗方法 | Surgical drapes, gownsand clean air suits, usedas medical devices forpatients, clinical staffand equipment —Part 2: Test methods |
| BS EN 13795-3-2006+A1-2009 | 用作醫(yī)療器械的患者,醫(yī)護人員和醫(yī)療器械用覆蓋巾,手術服和清潔空氣套裝.性能要求和性能等級 | Surgical drapes, gownsand clean air suits, usedas medical devices forpatients, clinical staffand equipment —Part 3: Performance requirements andperformance levels |
| BS EN 13824-2004 | 醫(yī)療設備的滅菌.液體醫(yī)療設備的無菌操作.要求 | Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements |
| BS EN 13975-2003 | 體外診斷用醫(yī)療裝置的驗收試驗用取樣規(guī)程.統(tǒng)計特性 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
| BS EN 14079-2003 | 非放射性的醫(yī)療裝置.脫脂紗布、脫脂棉和脫膠紗布的性能要求和試驗方法 | Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
| BS EN 14254-2004 | 體外診斷醫(yī)療設備.取自于人體的不包括血液的樣品用一次性容器 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| BS EN 14463-2007 | 醫(yī)學信息學.描述醫(yī)療分類系統(tǒng)內(nèi)容的術語.分類標記語言(ClaML) | Health informatics - A syntax to represent the content of medical classification systems - ClaML |
| BS EN 14484-2004 | 醫(yī)療信息學.EU數(shù)據(jù)保護指令中包含的個人醫(yī)療數(shù)據(jù)的國際傳送.高級安全政策 | Health informatics - International transfer of personal health data covered by the EU data protection directive - High level security policy |
| BS EN 14485-2004 | 醫(yī)療信息學.EU數(shù)據(jù)保護指令國際應用部分中的個人醫(yī)療數(shù)據(jù)的處理指南 | Health informatics - Guidance for handling personal health data in international applications in the context of the EU data protection directive |
| BS EN 14563-2008 | 化學消毒劑和防腐劑.醫(yī)療領域中器械用化學消毒劑的分枝桿菌或殺結核菌活性評估用定量帶菌體試驗.試驗方法和 | Chemical disinfectants and antiseptics - Quantitative carrier testfor the evaluation of mycobactericidal or tuberculocidal activity ofchemical disinfectants used for instruments in the medical area -Test method and requirements (phase 2, step 2) |
| BS EN 15424-2007 | 醫(yī)療設備滅菌.低溫蒸汽和甲醛滅菌器.醫(yī)療設備滅菌過程的制定、確認和常規(guī)控制的要求 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN 1639-2009 | 牙科學.牙科用醫(yī)療器械.儀器 | Dentistry - Medical devices for dentistry - Instruments |
| BS EN 1640-2009 | 牙科學.牙科用醫(yī)療器械.設備 | Dentistry - Medical devices for dentistry - Equipment |
| BS EN 1641-2009 | 牙科學.牙科用醫(yī)療器械.材料 | Dentistry - Medical devices for dentistry - Materials |
| BS EN 1642-2009 | 牙科學.牙科用醫(yī)療器械.牙科植入物 | Dentistry - Medical devices for dentistry - Dental implants |
| BS EN 1707-1997 | 注射器、針頭和其它特定醫(yī)療器械用有6%(路厄)錐度的圓錐形配件.鎖定配件 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| BS EN 455-1-2000 | 一次性醫(yī)療用手套.無孔洞要求和試驗 | Medical gloves for single use - Requirements and testing for freedom from holes |
| BS EN 455-2-2009 | 一次性醫(yī)療用手套.物理性能要求和試驗 | Medical gloves for single use - Requirements and testing for physical properties |
| BS EN 455-3-2006 | 一次性醫(yī)療用手套.生物評價的要求和試驗 | Medical gloves for single use — Part 3: Requirements and testing for biological evaluation |
| BS EN 45502-1-1998 | 活性可植入醫(yī)療裝置.制造商提供的安全,標記和信息的一般要求 | Active implantable medical devices - General requirements for safety, marking and information to be provided by the manufacturer |
| BS EN 45502-2-1-2004 | 活性可植入醫(yī)療器件.用于治療緩慢性心率失常的活性可植入醫(yī)療器件的特殊要求(心臟起搏器) | Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) |
| BS EN 45502-2-2-2008 | 有源可植入醫(yī)療器件.用于治療緩慢性心率失常的活性可植入醫(yī)療器件的特殊要求(心臟起搏器) | Active implantable medical devices - Part 2-2:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) |
| BS EN 550-1994 | 醫(yī)療裝置的殺菌.用環(huán)氧乙烷殺菌的驗證和常規(guī)控制 | Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization |
| BS EN 55011-2007 | 工業(yè)、科學和醫(yī)療(ISM)射頻設備.電磁干擾特征.極限值和測量方法 | Industrial, scientific and medical (ISM) radio-frequency Equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement |
| BS EN 55011-2009 | 工業(yè)、科學和醫(yī)療設備.射頻干擾特性.限值和測量方法 | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| BS EN 556-1-2001 | 醫(yī)療設備的殺菌.擬定為無菌的醫(yī)療設備的要求.對最終殺菌設備的要求 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices |
| BS EN 556-2-2004 | 醫(yī)療器械的滅菌.擬被認定為無菌的醫(yī)療設備的要求.無菌處理的醫(yī)療設備的要求 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices |
| BS EN 60336-2005 | 醫(yī)用電氣設備.醫(yī)療診斷用X-射線管組件.焦點特性 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| BS EN 60406-1997 | X射線醫(yī)療診斷用X射線膠片暗盒和乳腺X射線膠片暗盒 | Specification for radiographic cassettes and mammographic cassettes used for medical X-ray diagnosis |
| BS EN 60598-2-25-1995 | 燈具.第2部分:專門要求.第25節(jié):醫(yī)院和醫(yī)療保健中心臨床用燈具 | Luminaires - Part 2.25: Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings |
| BS EN 60601-1-2006 | 醫(yī)療電氣設備.基本安全和基本性能的一般要求 | Medical electrical equipment - General requirements for basic safety and essential performance |
| BS EN 60601-1-3-2008 | 醫(yī)療電氣設備.基本安全和重要性能的通用要求.附屬標準.X射線診斷設備的輻射防護 | Medical electrical equipment -Part 1-3: General requirements for basic safety and essential performance - Collateral Standard - Radiation protection in diagnostic X-ray equipment |
| BS EN 60601-1-8-2004 | 醫(yī)療電氣設備.安全的一般要求.并列標準.醫(yī)療電氣設備和醫(yī)療電氣系統(tǒng)中警報系統(tǒng)的一般要求、試驗和指南 | Medical electrical equipment - General requirements for safety - Collateral standard - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| BS EN 60601-1-8-2007 | 醫(yī)用電氣設備.基本安全和基本性能的通用要求.間接標準:醫(yī)療電氣設備和醫(yī)療電氣系統(tǒng)中警報系統(tǒng)的一般要求、 | Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| BS EN 60601-1-9-2008 | 醫(yī)療設備綜合.基本安全和基本性能的通用要求.間接標準.環(huán)保意識的設計的要求 | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard - Requirements for environmentally conscious design |
| BS EN 60601-2-12-2006 | 醫(yī)療電氣設備.第2-12部分:肺呼吸機安全性的特殊要求.危急護理呼吸機 | Medical electrical equipment - Particular requirements for the safety of lung ventilators - Critical care ventilators |
| BS EN 60601-2-17-2004 | 醫(yī)療電氣設備.自動控制短距離放射治療后裝設備安全的特殊要求 | Medical electrical equipment - Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
| BS EN 60601-2-19-2009 | 醫(yī)療電氣設備.嬰兒保溫箱基本安全和主要性能的特殊要求 | Medical electrical equipment - Part 2-19:Particular requirements for the basic safety and essential performance of infant incubators |
| BS EN 60601-2-22-1996 | 醫(yī)療電氣設備.安全專門要求.激光診斷和治療設備規(guī)范 | Medical electrical equipment - Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment |
| BS EN 60601-2-23-2000 | 醫(yī)療電氣設備.經(jīng)皮分壓監(jiān)測設備的安全性用特殊要求(包括基本性能) | Medical electrical equipment - Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment |
| BS EN 60601-2-24-1998 | 醫(yī)療電氣設備.特殊安全要求.輸液泵和控制器的特殊安全要求. | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of infusion pumps and controllers |
| BS EN 60601-2-25-1996 | 醫(yī)療電氣設備.安全的特殊要求.心電圖儀 | Medical electrical equipment - Particular requirements for safety - Specification for electrocardiographs |
| BS EN 60601-2-27-2006 | 醫(yī)療電氣設備.第2-27部分:心電圖監(jiān)測設備的安全(包括基本性能)特殊要求 | Medical electricalequipment —Part 2-27: Particular requirements forthe safety, including essentialperformance, of electrocardiographicmonitoring equipment |
| BS EN 60601-2-29-2008 | 醫(yī)療電氣設備.放射線療法模擬器基本安全和重要性能的特殊要求 | Medical electrical equipment —Part 2-29: Particular requirements for the basic safetyand essential performance of radiotherapy simulators |
| BS EN 60601-2-3-1993 | 醫(yī)療電氣設備.特殊安全要求.短波治療設備規(guī)范 | Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment |
| BS EN 60601-2-33-2002+A2-2008 | 醫(yī)用電氣設備.第2-33部分:醫(yī)療診斷用磁共振設備的安全性特殊要求 | Medical electrical equipment -Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis |
| BS EN 60601-2-34-2001 | 醫(yī)療電氣設備.安全性用特殊要求.直接血壓監(jiān)護設備安全性用特殊要求(包括基本性能) | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment |
| BS EN 60601-2-37-2001 | 醫(yī)用電氣設備.第2-37部分:超聲波醫(yī)療診斷和監(jiān)測設備的特殊安全要求 | Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment |
| BS EN 60601-2-37-2008 | 醫(yī)療電氣設備.超聲波醫(yī)療診斷和監(jiān)測設備基本安全和重要性能的特殊要求 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| BS EN 60601-2-39-2008 | 醫(yī)療電氣設備.腹膜透析設備的基本安全和重要性能的特殊要求 | Medical electrical equipment —Part 2-39: Particular requirements for basic safety andessential performance of peritoneal dialysisequipment |
| BS EN 60601-2-4-2003 | 醫(yī)療電氣設備.安全的特殊要求.心臟去纖顫器的特殊安全要求 | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of cardiac defibrillators |
| BS EN 60601-2-40-1998 | 醫(yī)療電氣設備.特殊安全要求.筋骨電流計和誘發(fā)反應設備規(guī)范 | Medical electrical equipment - Particular requirements for safety - Specification for electromyographs and evoked response equipment |
| BS EN 60601-2-41-2009 | 醫(yī)療電氣設備.外科手術燈和診斷用燈基本安全性和本質(zhì)性能的特殊要求 | Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
| BS EN 60601-2-43-2001 | 醫(yī)療電氣設備.安全性用特殊要求.介入過程用X射線設備安全性用專用要求 | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of X-ray equipment for interventional procedures |
| BS EN 60601-2-49-2001 | 醫(yī)療用電氣設備.多功能病人監(jiān)測設備安全的專門要求 | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of multifunction patient monitoring equipment |
| BS EN 60601-2-50-2002 | 醫(yī)療用電氣設備.安全性的特殊要求.嬰幼兒光線治療設備的安全性特殊要求 | Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of infant phototherapy equipment |
| BS EN 60601-2-51-2003 | 醫(yī)療電氣設備.記錄和分析單道和多道心電描記器的安全性特殊要求(包括主要性能) | Medical electrical equipment - Particular requirements for safety - Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
| BS EN 60806-2004 | 醫(yī)療診斷用旋轉(zhuǎn)陽極X射線管最大對稱輻射場強度測定 | Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis |
| BS EN 60976-2007 | 醫(yī)療電氣設備.醫(yī)療電子加速器.功能的特性特征 | Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| BS EN 61010-2-040-2005 | 測量、控制和實驗室用電氣設備的安全要求.第2-040部分:醫(yī)療材料處理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 |
| BS EN 61010-2-101-2002 | 測量、控制和實驗室用電氣設備的安全要求.實驗室診斷(IVD)醫(yī)療設備的特殊要求 | Safety requirements for electrical equipment for measurement, control and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment |
| BS EN 61157-2007 | 醫(yī)療診斷超聲波設備聲輸出的報告用標準方法 | Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment |
| BS EN 61223-3-1-1999 | 醫(yī)療成像部門的評定及常規(guī)試驗.驗收試驗.輻射照相和輻射顯微照相系統(tǒng)用X射線設備的成像性能 | Evaluation and routine testing in medical imaging departments - Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems |
| BS EN 61223-3-4-2000 | 醫(yī)療成像部門的評定及常規(guī)試驗.驗收試驗.牙科X射線設備成像性能 | Evaluation and routine testing in medical imaging departments - Acceptance tests |
| BS EN 61223-3-5-2004 | 醫(yī)療成像部門的評價及常規(guī)試驗.驗收試驗.計算機斷層攝影X射線設備的成像性能 | Evaluation and routine testing in medical imaging departments - Acceptance tests - Imaging performance of computed tomography X-ray equipment |
| BS EN 61262-1-1995 | 醫(yī)療電氣設備用光電X射線圖象增強器的特性.第1部分:入口視場尺寸的測定 | Characteristics of electro-optical X-ray image intensifiers for medical electrical equipment - Determination of the entrance field size |
| BS EN 61262-2-1995 | 醫(yī)療電氣設備用光電X射線圖像增強器的特性.換算系數(shù)的測定 | Characteristics of electro-optical X-ray image intensifiers for medical electrical equipment - Determination of the conversion factor |
| BS EN 61262-5-1995 | 醫(yī)療電氣設備用光電X射線圖象增強器的特性.檢測量子效率的測定 | Characteristics of electro-optical X-ray image intensifiers for medical electrical equipment - Determination of the detective quantum efficiency |
| BS EN 61326-2-6-2006 | 測量、控制和實驗室用電氣設備.電磁兼容性(EMC)的要求.特殊要求.實驗室診斷(IVD)醫(yī)療設備 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Particular requirements - In vitro diagnostic (IVD) medical equipment |
| BS EN 61331-1-1995 | 醫(yī)療診斷時防X射線輻射的防護器具.材料的衰減性能的測定 | Protective devices against diagnostic medical X-radiation - Determination of attenuation properties of materials |
| BS EN 61331-2-1995 | 醫(yī)療診斷時防X射線輻射的防護器具.防護玻璃板 | Protective devices against diagnostic medical X-radiation - Protective glass plates |
| BS EN 61331-3-1999 | X射線醫(yī)療診斷保護裝置.生殖腺防護裝置和防護服裝 | Protective devices against diagnostic medical X-radiation - Protective clothing and protective devices for gonads |
| BS EN 61676-2002+A1-2009 | 醫(yī)療電氣設備.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 |
| BS EN 62127-1-2007 | 超聲學.水聽器.第1部分:醫(yī)療超聲波場頻率小于40MHz的測量和特性 | Ultrasonics —Hydrophones —Part 1: Measurement andcharacterization of medical ultrasonicfields up to 40 MHz |
| BS EN 62220-1-2004 | 醫(yī)療電氣設備.數(shù)字X光成像設備特性.量子檢測效率的確定 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Determination of the detective quantum efficiency |
| BS EN 62220-1-3-2008 | 醫(yī)療電氣設備.數(shù)字X射線成像裝置的特性.探測量子效率的測定.動態(tài)成像用探測器 | Medical electrical equipment —Characteristics of digital X-rayimaging devices —Part 1-3: Determination of the detective quantumefficiency — Detectors used in dynamic imaging |
| BS EN 62274-2005 | 醫(yī)療電氣設備.放射療法記錄和檢驗系統(tǒng)的安全 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
| BS EN 62304-2006 | 醫(yī)療器械軟件.軟件使用周期過程 | Medical device software - Software life-cycle processes |
| BS EN 62353-2008 | 醫(yī)療電氣設備.醫(yī)療電氣設備的循環(huán)試驗和維修后試驗 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| BS EN 62359-2005 | 超聲波學.場特征.醫(yī)療診斷超聲場相關熱和機械指數(shù)測定的試驗方法 | Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| BS EN 62366-2008 | 醫(yī)療設備.醫(yī)療設備可用性工程的應用 | Medical devices - Application of usability engineering to medical devices |
| BS EN 62464-1-2007 | 醫(yī)療成象磁共振設備.實際成象質(zhì)量參數(shù)測定 | Magnetic resonance equipment for medical imaging - Determination of essential image quality parameters |
| BS EN 62494-1-2008 | 醫(yī)療電氣設備.數(shù)字X射線成像系統(tǒng)用曝光指數(shù).一般X射線照相術用定義和要求 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Definitions and requirements for general radiography |
| BS EN 80601-2-35-2009 | 醫(yī)療電氣設備.應用于加熱的毛毯,襯墊或床墊及醫(yī)用加熱裝置基本安全及基本性能的特殊規(guī)范 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| BS EN 80601-2-58-2009 | 醫(yī)療電氣設備.眼科手術用晶狀體移除裝置和玻璃體切除裝置基本安全和基本性能的特殊要求 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| BS EN 868-10-2009 | 滅菌醫(yī)療裝置的包裝.聚烯烴粘性涂覆非織物材料.要求和測試方法 | Packaging for terminally sterilized medical devices - Adhesive coated nonwoven materials of polyolefines - Requirements and test methods |
| BS EN 868-2-2009 | 滅菌醫(yī)療裝置的包裝.滅菌套要求和測試方法 | Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods |
| BS EN 868-3-2009 | 滅菌醫(yī)療裝置的包裝.生產(chǎn)紙袋(EN 868-4規(guī)定)和生產(chǎn)盒和卷筒用紙(EN 868-5規(guī)定)要求和試驗方法 | Packaging for terminally sterilized medical devices - Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods |
| BS EN 868-4-2009 | 滅菌醫(yī)療裝置的包裝.紙袋要求和測試方法 | Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods |
| BS EN 868-5-2009 | 滅菌醫(yī)療裝置的包裝.多孔和塑料薄膜結構的密封袋和卷軸.要求和測試方法 | Packaging for terminally sterilized medical devices - Sealable pouches and reels of porous and plastic film construction - Requirements and test methods |
| BS EN 868-6-2009 | 滅菌醫(yī)療裝置的包裝.低溫滅菌處理用紙.要求和測試方法 | Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods |
| BS EN 868-7-2009 | 滅菌醫(yī)療裝置的包裝.低溫消毒處理用粘合銅版紙.要求和測試方法 | Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes - Requirements and test methods |
| BS EN 868-8-2009 | 滅菌醫(yī)療裝置的包裝.符合EN 285標準的蒸汽滅菌器用再用滅菌容器.要求和測試方法 | Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods |
| BS EN 868-9-2009 | 滅菌醫(yī)療裝置的包裝.第9部分:聚烯烴非包覆非織物材料.要求和測試方法 | Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods |
| BS EN 980-2008 | 醫(yī)療器械標簽用圖形符號 | Symbols for use in the labelling of medical devices |
| BS EN ISO 10079-1-2009 | 醫(yī)療吸引設備.第1部分:電動吸引設備安全要求(ISO 10079-1:1999) | Medical suctionequipmentPart 1: Electrically powered suctionequipment — Safety requirements (ISO10079-1:1999) |
| BS EN ISO 10079-3-2009 | 醫(yī)療吸引設備.第3部分:真空或用壓力驅(qū)動的吸引設備(ISO 10079-3:1999) | Medical suctionequipmentPart 3: Suction equipment poweredfrom a vacuum or pressure source (ISO10079-3:1999) |
| BS EN ISO 10524-4-2008 | 醫(yī)療氣體用壓力調(diào)節(jié)器.低壓調(diào)節(jié)器 | Pressure regulators for use with medical gases - Low-pressure regulators |
| BS EN ISO 10993-10-2009 | 醫(yī)療裝置的生物學評估.刺激和遲延型超敏性試驗 | Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity |
| BS EN ISO 10993-11-2009 | 醫(yī)療器械的生物學評價.全身毒性試驗 | Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006) |
| BS EN ISO 10993-12-2009 | 醫(yī)療器械的生物評定.樣品制備和標樣 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) |
| BS EN ISO 10993-13-2009 | 醫(yī)療器械的生物學評價.陶瓷降解產(chǎn)物的識別和定量 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) |
| BS EN ISO 10993-14-2009 | 醫(yī)療器械的生物學評價.陶瓷降解產(chǎn)物的識別和定量 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| BS EN ISO 10993-15-2009 | 醫(yī)療器械的生物評定.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 degradationproducts from metals and alloys (ISO 10993-15:2000) |
| BS EN ISO 10993-16-2010 | 醫(yī)療器械的生物學評定.降解產(chǎn)物和可濾取物的毒物動力學研究設計 | Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables |
| BS EN ISO 10993-17-2009 | 醫(yī)療器械的生物學評價.浸出物允許限量的確定 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| BS EN ISO 10993-18-2009 | 醫(yī)療器械的生物學評價.材料的化學表征 | Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| BS EN ISO 10993-2-2006 | 醫(yī)療器械的生物評定.動物保護要求 | Biological evaluation of medical devices - Animal welfare requirements |
| BS EN ISO 10993-3-2009 | 醫(yī)療器械的生物學評價.遺傳毒性,致癌性和生殖毒性試驗 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) |
| BS EN ISO 10993-4-2009 | 醫(yī)療器械的生物評估.與血液相互作用的試驗選擇 | Biological evaluation of medical devices - Selection of tests for interactions with blood |
| BS EN ISO 10993-5-2009 | 醫(yī)療器械生物學評價.細胞毒性體外試驗法 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| BS EN ISO 10993-6-2009 | 醫(yī)療器械的生物學評價.植入后的局部效應試驗 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
| BS EN ISO 10993-7-2008 | 醫(yī)療器械的生物學評估.環(huán)氧乙烷滅菌殘留量 | Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals |
| BS EN ISO 11073-10101-2006 | 健康信息學.床旁檢測醫(yī)療設備通信.術語 | Health informatics - Point-of-care medical device communications - Nomenclature |
| BS EN ISO 11073-10201-2006 | 健康信息學.床旁檢測醫(yī)療設備通信.傳輸輪廓.域信息模式 | Health informatics - Point-of-care medical device communication - Domain information model |
| BS EN ISO 11073-20101-2005 | 健康信息學.床旁檢測醫(yī)療設備通信.應用輪廓.基本標準 | Health informatics - Point-of-care medical device communication - Application profiles - Base standard |
| BS EN ISO 11073-30200-2006 | 健康信息學.床旁檢測醫(yī)療設備通信.傳輸輪廓.連接電纜 | Health informatics - Point-of-care medical device communication - Transport profile - Cable connected |
| BS EN ISO 11073-30300-2006 | 健康信息學.床旁檢測醫(yī)療設備通信.傳輸輪廓.紅外無線 | Health informatics - Point-of-care medical device communication - Transport profile - Infrared wireless |
| BS EN ISO 11135-1-2007 | 衛(wèi)生保健品滅菌.環(huán)氧乙烷.醫(yī)療設備滅菌過程的制定、確認和常規(guī)控制的要求 | Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 11137-1-2006 | 保健產(chǎn)品的滅菌.輻射.醫(yī)療器械消毒程序的建立、確認、和常規(guī)控制的要求 | Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 11138-1-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物.一般要求 | Sterilization of health care products - Biological indicators - General requirements |
| BS EN ISO 11138-2-2009 | 醫(yī)療保健產(chǎn)品滅菌.生物指示劑.環(huán)氧乙烷滅菌用生物指示劑 | Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes |
| BS EN ISO 11138-3-2009 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物.濕熱滅菌處理用生物指示劑 | Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes |
| BS EN ISO 11138-4-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物.干熱滅菌用生物指示劑 | Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes |
| BS EN ISO 11138-5-2006 | 醫(yī)療保健產(chǎn)品滅菌.生物指示物.低溫蒸汽和甲醛滅菌用生物指示劑 | Sterilization of health care products - Biological indicators - Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| BS EN ISO 11737-2-2009 | 醫(yī)療器械的消毒.微生物學法.滅菌過程的定義、有效性和維護中進行的無菌試驗 | Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| BS EN ISO 13485-2003 | 醫(yī)療設備.質(zhì)量管理體系.管理要求 | Medical devices - Quality management systems - Requirements for regulatory purposes |
| BS EN ISO 13606-5-2010 | 醫(yī)療信息學.電子健康記錄通信.接口規(guī)范 | Health informatics - Electronic health record communication - Interface specification |
| BS EN ISO 14155-1-2009 | 人用醫(yī)療設備的臨床調(diào)查.一般要求 | Clinical investigation of medical devices for human subjects - General requirements |
| BS EN ISO 14155-2-2009 | 醫(yī)學研究受驗者用醫(yī)療器械的臨床調(diào)查.臨床調(diào)查計規(guī)劃 | Clinical investigation of medical devices for human subjects - Clinical investigation plans |
| BS EN ISO 14161-2009 | 醫(yī)療保健產(chǎn)品的滅菌.生物指示器.選擇、使用和檢驗結果解釋用指南 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
| BS EN ISO 14937-2009 | 保健產(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 |
| BS EN ISO 14971-2009 | 醫(yī)療器械.醫(yī)療器械風險管理的應用 | Medical devices - Application of risk management to medical devices |
| BS EN ISO 15002-2008 | 醫(yī)療氣體管道系統(tǒng)連接到終端裝置用流量測量裝置 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| BS EN ISO 15193-2009 | 體外診斷醫(yī)療器械.生物源樣品的數(shù)量測量.參考測量程序的內(nèi)容和表示要求 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures |
| BS EN ISO 15194-2009 | 體外診斷醫(yī)療器械.生物源樣品的數(shù)量測量.證明文件的認證參考材料和內(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 |
| BS EN ISO 15225-2010 | 醫(yī)療器械.質(zhì)量管理.醫(yī)療器械命名資料結構 | Medical devices - Quality management - Medical device nomenclature data structure |
| BS EN ISO 17664-2004 | 醫(yī)療器械的消毒.生產(chǎn)商提供的可再消毒醫(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 |
| BS EN ISO 17665-1-2006 | 醫(yī)療保健產(chǎn)品滅菌.濕熱.醫(yī)療器械滅菌過程技術革新、檢驗、日程控制的要求 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| BS EN ISO 18104-2004 | 醫(yī)療信息學.護理用參考術語模式的綜合 | Health informatics - Integration of a reference terminology model for nursing |
| BS EN ISO 18113-1-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標簽).術語、定義和一般要求 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements |
| BS EN ISO 18113-2-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標簽).專業(yè)用途的體外診斷試劑 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for professional use |
| BS EN ISO 18113-3-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標簽).專業(yè)用體外診斷儀器 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for professional use |
| BS EN ISO 18113-4-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標簽).自測用體外診斷劑 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing |
| BS EN ISO 18113-5-2009 | 體外診斷醫(yī)療器械.制造商提供的信息(標簽).自試驗用體外診斷儀器 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for self-testing |
| BS EN ISO 18779-2005 | 儲備氧氣和氧氣混合物的醫(yī)療設備.特殊要求 | Medical devices for conserving oxygen and oxygen mixtures - Particular requirements |
| BS EN ISO 18812-2003 | 醫(yī)療信息學.醫(yī)用分析儀與實驗室信息系統(tǒng)的接口.使用說明文件 | Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles |
| BS EN ISO 21171-2006 | 醫(yī)療專用手套.可移動表面粉末的測定 | Medical gloves - Determination of removable surface powder |
| BS EN ISO 21549-1-2004 | 醫(yī)療信息學.病人醫(yī)療卡數(shù)據(jù).通用結構 | Health informatics - Patient healthcard data - General structure |
| BS EN ISO 21549-2-2004 | 醫(yī)療信息學.病人醫(yī)療卡數(shù)據(jù).共同對象 | Health informatics - Patient healthcard data - Common objects |
| BS EN ISO 21549-3-2004 | 醫(yī)療信息學.病人醫(yī)療卡數(shù)據(jù).有限的臨床數(shù)據(jù) | Health informatics - Patient healthcard data - Limited clinical data |
| BS EN ISO 21549-5-2008 | 醫(yī)療信息學.病人醫(yī)療卡數(shù)據(jù).鑒定數(shù)據(jù) | Health informatics - Patient healthcard data - Identification data |
| BS EN ISO 21549-6-2008 | 醫(yī)療信息學.病人醫(yī)療卡數(shù)據(jù).管理數(shù)據(jù) | Health informatics - Patient healthcard data - Administrative data |
| BS EN ISO 21969-2009 | 同醫(yī)療氣體設備一起使用的高壓撓性連接件 | High-pressure flexible connections for use with medical gas systems |
| BS EN ISO 22442-1-2008 | 醫(yī)療設備用動物組織及其衍生物.風險管理的應用 | Medical devices utilizing animal tissues and their derivatives - Application of risk management |
| BS EN ISO 22442-2-2008 | 醫(yī)療設備用動物組織及其衍生物.來源控制、采集和處理 | Medical devices utilizing animal tissues and their derivatives - Controls on sourcing, collection and handling |
| BS EN ISO 22442-3-2008 | 醫(yī)療設備用動物組織及其衍生物.病毒和傳染性海綿狀腦病(TSE)試劑的消滅和/或失效的確認 | Medical devices utilizing animal tissues and their derivatives - Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| BS EN ISO 22610-2007 | 病人和醫(yī)務人員作為醫(yī)療用具的外科被單、長衣和無菌套裝和設備.第3部分:性能要求和性能水平 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration |
| BS EN ISO 23747-2009 | 麻醉設備和醫(yī)療呼吸設備.自然呼吸的人類的肺功能測定用呼氣峰值流量表 | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| BS EN ISO 5359-2008 | 醫(yī)療氣體設備用低壓軟管組件 | Low-pressure hose assemblies for use with medical gases |
| BS EN ISO 7405-2008 | 牙科學.牙科用醫(yī)療器械生物相容性評估 | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| BS EN ISO 9170-1-2008 | 醫(yī)療氣體管道系統(tǒng)用終端設備.醫(yī)療壓縮氣體和真空用終端設備 | Terminal units for medical gas pipeline systems - Terminal units for use with compressed medical gases and vacuum |
| BS EN ISO 9626-1991 | 醫(yī)療器具制造用的不銹鋼針管 | Stainless steel needle tubing for the manufacture of medical devices |
| BS EN ISO 9919-2009 | 醫(yī)療電氣設備.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 (ISO 9919:2005) |
| BS EN ISO10993-10-2002 | 醫(yī)療器械的生物評定.刺激與持續(xù)過敏癥試驗 | Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity |
| BS IEC 61223-2-10-2000 | 醫(yī)療成像部門的評估及例行試驗.穩(wěn)定性試驗.乳房X線照相術用X射線設備 | Evaluation and routine testing in medical imaging departments - Constancy tests - X-ray equipment for mammography |
| BS IEC 61223-2-11-2000 | 醫(yī)療圖象部門的評定和常規(guī)試驗.穩(wěn)定性試驗.通用直接輻射攝影設備 | Evaluation and routine testing in medical imaging departments - Constancy tests - Equipment for general direct radiography |
| BS IEC 61223-2-7-2000 | 醫(yī)療成像部門的評估及例行試驗.穩(wěn)定性試驗.不包括牙齒全景設備的口腔內(nèi)牙科射線照相術用設備 | Evaluation and routine testing in medical imaging departments - Constancy tests - Equipment for intra-oral dental radiography excluding dental panoramic equipment |
| BS IEC 61223-2-9-2000 | 醫(yī)療成像部門的評估及例行試驗.穩(wěn)定性試驗.間接放射線透視和間接射線照相術用設備 | Evaluation and routine testing in medical imaging departments - Constancy tests - Equipment for indirect radioscopy and indirect radiography |
| BS ISO 11073-90101-2008 | 健康信息學.床旁監(jiān)護用醫(yī)療裝置通信.分析儀器.床旁監(jiān)護試驗 | Health informatics - Point-of-care medical device communication - Analytical instruments - Point-of-care test |
| BS ISO 11195-1996 | 醫(yī)療用氣體混合器.獨立氣體混合器 | Gas mixers for medical use - Stand-alone gas mixers |
| BS ISO 13606-2-2008 | 醫(yī)療信息學.電子健康記錄信息.原型交換規(guī)范 | Health informatics - Electronic health record communication - Archetype interchange specification |
| BS ISO 15198-2004 | 臨床實驗室藥物.體外診斷醫(yī)療設備.由制造商證實的用戶質(zhì)量控制程序 | Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer |
| BS ISO 16428-2005 | 外科植入物.可植入物質(zhì)和醫(yī)療裝置的靜態(tài)和動態(tài)腐蝕試驗用試驗溶液和環(huán)境條件 | Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices |
| BS ISO 17090-1-2008 | 醫(yī)療信息學.公開密鑰基礎設施.數(shù)字證書服務的綜述 | Health informatics - Public key infrastructure - Overview of digital certificate services |
| BS ISO 17432-2005 | 醫(yī)療信息學.文電和通信.DICOM持續(xù)對象的網(wǎng)上存取 | Health informatics - Messages and communication - Web access to DICOM persistent objects |
| BS ISO 17593-2007 | 臨床實驗室測試和體外醫(yī)療設備.口服抗凝血劑治療自測用體外監(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 |
| BS ISO 28620-2010 | 醫(yī)療設備.非電驅(qū)動的便攜式輸液設備 | Medical devices - Non-electrically driven portable infusion devices |
| BS ISO 4090-2001 | 攝影.醫(yī)療放射照相用X光底片盒/屏蔽物/膠片和硬拷貝成像膠片.尺寸和規(guī)范 | Photography - Medical radiographic cassettes/screens/films and hard-copy imaging films - Dimensions and specifications |
| BS ISO 5799-1995 | 攝影技術.醫(yī)療用和牙科用直接爆光射線攝影膠片/沖洗系統(tǒng).ISO感光速度和ISO平均梯度的測定 | Photography - Direct-exposing medical and dental radiographic film/process systems - Determination of ISO speed and ISO average gradient |
| BS ISO 8600-2-2002 | 光學和光學儀器.醫(yī)療內(nèi)診鏡和內(nèi)診鏡附件.對剛性支氣管鏡的特殊要求 | Optics and optical instruments - Medical endoscopes and endoscopic accessories - Particular requirements for rigid bronchoscopes |
| BS ISO 8600-4-1997 | 光學和光學儀器.醫(yī)療用內(nèi)診鏡和內(nèi)診鏡附件.插入段最大寬度的測定 | Optics and optical instruments - Medical endoscopes and endoscopic accessories - Determination of maximum width of insertion portion |
| BS N 6-1998 | 航空醫(yī)療用便攜式氧濃縮器系統(tǒng)規(guī)范.一般要求 | Specification for aeromedical portable oxygen concentrator systems - General requirements |
| BS PAS 131-2007 | 納米技術的醫(yī)療、健康和個人護理設備用術語 | Terminology for medical, health and personal care applications of nanotechnology |
| DD ENV 12017-1998 | 醫(yī)療信息學.醫(yī)療信息學詞匯(MIVoc) | Medical informatics. Medical informatics vocabulary (MIVoc) |
| DD ENV 12052-1998 | 醫(yī)療信息學.醫(yī)療成像通信(MEDICOM) | Medical informatics. Medical imaging communication (MEDICOM) |
| DD ENV 12264-1998 | 醫(yī)療信息學.概念體系分類結構.語義學表述模型 | Medical informatics. Categorical structures of systems of concepts. Model for representation of semantics |
| DD ENV 12435-2000 | 醫(yī)療信息學.醫(yī)療科學測量結果的表示 | Medical informatics. Expression of results of measurements in health sciences |
| DD ENV 12443-2001 | 醫(yī)療信息學.保健信息框架 | Medical informatics. Healthcare information framework (HIF) |
| DD ENV 12537-1-1998 | 醫(yī)療信息學.保健電子數(shù)據(jù)交換信息的信息對象登記.寄存器 | Medical informatics. Registration of information objects used for EDI in healthcare. The register |
| DD ENV 12537-2-1998 | 醫(yī)療信息學.保健電子數(shù)據(jù)交換用信息目標的注冊.保健電子數(shù)據(jù)交換用信息目標的注冊程序 | Medical informatics. Registration of information objects used for EDI in healthcare. Procedures for the registration of information objects used in electronic data interchange (EDI) in healthcare |
| DD ENV 12538-1998 | 醫(yī)療信息學.病人治療安排和出院信息 | Medical informatics. Messages for patient referral and discharge |
| DD ENV 12539-1998 | 醫(yī)療信息學.診斷服務部門的要求和報告信息 | Medical informatics. Request and report messages for diagnostic service departments |
| DD ENV 12610-1998 | 醫(yī)療信息學.醫(yī)療產(chǎn)品鑒別 | Medical informatics. Medical product identification |
| DD ENV 12611-1998 | 醫(yī)療信息學.概念體系的分類結構.醫(yī)療設備 | Medical informatics. Categorical structure of systems of concepts. Medical devices |
| DD ENV 12612-1998 | 醫(yī)療信息學.保健管理信息交換用信息 | Medical informatics. Messages for the exchange of healthcare administrative information |
| DD ENV 12623-1998 | 醫(yī)療信息學.醫(yī)療成像通信的介質(zhì)互換(MI-MEDICOM) | Medical informatics. Media interchange in Medical imaging communications (MI-MEDICOM) |
| DD ENV 12922-1-1998 | 醫(yī)療成像管理.存儲委托服務類別 | Medical image management. Storage commitment service class |
| DD ENV 12924-1998 | 醫(yī)療信息學.保健信息系統(tǒng)的安全分類和保護 | Medical informatics. Security categorisation and protection for healthcare information systems |
| DD ENV 13607-2000 | 醫(yī)療衛(wèi)生信息.醫(yī)療處方信息交換用信息 | Health informatics. Messages for the exchange of information on medicine prescriptions |
| DD ENV 13735-2001 | 健康信息學.病人身體接用的醫(yī)療設備間的互操作性 | Health informatics. Interoperability of patient connected medical devices |
| DD ENV 1613-1996 | 醫(yī)療信息學.實驗室數(shù)據(jù)交換用信息 | Medical informatics. Messages for exchange of laboratory information |
| DD ENV 1828-1996 | 醫(yī)療信息學.外科程序分類和編碼用結構 | Medical informatics. Structure for classification and coding of surgical procedures |
| PAS 131-2007 | 納米技術應用在醫(yī)療、健康和個人護理的術語 | Terminology for medical,health and personal careapplications ofnanotechnology |
| PD 13058-1998 | 醫(yī)療數(shù)據(jù)互換:在ENV 12539-97和NEMA PS 3附錄10規(guī)定的模型間的映象 | Medical data interchange: Mapping between the models specified in ENV 12539:1997 and NEMA PS 3 Supplement 10 |
| PD 6610-1997 | 醫(yī)療信息學.保健信息編制方法 | Medical informatics. Methodology for the development of healthcare messages |
| PD CEN/TR 15640-2007 | 醫(yī)療信息學.確保病人安全的醫(yī)療軟件的測量 | Health informatics —Measures for ensuringthe patient safety ofhealth software |
| PD CR 14230-2001 | 管理數(shù)據(jù)交換用全球醫(yī)療設備命名 | Global medical device nomenclature for the purpose of regulatory data exchange |
| PD IEC TR 61010-3-041-2002 | 測量、控制和實驗室用電氣設備的安全要求.IEC 61010-2-041:1995的合格評定報告.醫(yī)療材料處理和實驗室試驗用 | Safety requirements for electrical equipment for measurement, control, and laboratory use. Conformity verification report for IEC 61010-2-041:1995. Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes |
| PD IEC TR 61010-3-042-2002 | 測量、控制和實驗室用電氣設備的安全要求.IEC 61010-2-042:1997.醫(yī)療材料處理和實驗室處理用蒸壓器和消毒器 | Safety requirements for electrical equipment for measurement, control, and laboratory use. Conformity verification report for IEC 61010-2-042:1997, particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes |
| PD IEC TR 61010-3-043-2002 | 測量、控制和實驗室用電氣設備的安全要求.IEC 61010-2-043:1997<醫(yī)療材料處理和實驗室試驗用熱空氣或熱惰性 | Safety requirements for electrical equipment for measurement, control, and laboratory use. Conformity verification report for IEC 61010-2-043:1997. Particular requirements for dry heat sterilizers using either hot air or hot inert gas for treatment of medical materials and for laboratory processes |
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