標(biāo)準(zhǔn)號(hào) |
中文名稱 |
英文名稱 |
| ANSI/AAMI ST 60-1996 |
保健產(chǎn)品的滅菌.化學(xué)指示物.第1部分:一般要求 |
Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements |
| ANSI/AAMI ST 8-1994 |
醫(yī)院用蒸汽滅菌器 |
Hospital Steam Sterilizers |
| ANSI/AAMI ST35-2003 |
保健機(jī)構(gòu)和非門診單位醫(yī)療裝置的生物凈化和安全處理 |
(Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings ) |
| ANSI/AAMI ST40-2004 |
牙科和醫(yī)療設(shè)施中臺(tái)式干熱(加熱的空氣)滅菌和無菌性保證 |
|
| ANSI/AAMI ST44-2002 |
表征生物和化學(xué)指示劑性能用的電阻計(jì) |
(Resistometers Used for Characterizing the Performance of Biological and Chemical Indicators ) |
| ANSI/AAMI ST46-2002 |
良好的醫(yī)院操作規(guī)程:蒸氣滅菌和滅菌保證 |
(Good Hospital Practice: Steam Sterilization and Sterility Assurance ) |
| ANSI/AAMI ST50-2004 |
干熱(加熱空氣)滅菌器 |
|
| ANSI/AAMI ST58-A 1-2002 |
醫(yī)療保健機(jī)構(gòu)中戊二醛產(chǎn)品的安全使用和處理.修改件1 |
(Safe Use and Handling of Glutaraldehyde-Based Products in Health Care Facilities, Amendment 1 ) |
| ANSI/AAMI ST63-2002 |
保健制品的滅菌.醫(yī)療器械工業(yè)滅菌過程的設(shè)計(jì)、批準(zhǔn)和常規(guī)控制的要求.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/IEC 60601-2-21 & 60601-2-21 AMD 1-2000 |
醫(yī)療電氣設(shè)備.第2部分:嬰兒輻射保溫箱安全性的特殊要求 |
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Infant Radiant Warmers |
| ANSI/AAMI/ISO 10993-1 to 10993-6 & 10993-11-1993 |
醫(yī)療器械的生物評(píng)定.第1-6和11部分:收集 |
Biological Evaluation of Medical Devices - Parts 1 to 6 & 11: A Collection |
| ANSI/AAMI/ISO 10993-1-2003 |
醫(yī)學(xué)器械的生物學(xué)評(píng)價(jià).第1部分:試驗(yàn)選擇指南 |
(Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests ) |
| ANSI/AAMI/ISO 10993-10-1995 |
醫(yī)學(xué)器械的生物學(xué)評(píng)價(jià).第10部分:刺激性和敏感性試驗(yàn) |
Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization |
| ANSI/AAMI/ISO 10993-11-1993 |
醫(yī)療器械的生物評(píng)定.第11部分:系統(tǒng)毒性測(cè)試(收集在ANSI/AAMI/ISO 10993-93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 10993-12-2002 |
醫(yī)療器械的生物評(píng)定.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 10993-14-2001 |
醫(yī)療器械的生物評(píng)定.第14部分:來自陶瓷的降解產(chǎn)品的識(shí)別和定量 |
Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics |
| ANSI/AAMI/ISO 10993-16-1997 |
醫(yī)療器械的生物評(píng)定.第16部分:降解產(chǎn)品和可瀝濾物質(zhì)毒性研究設(shè)計(jì) |
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(píng)定.第17部分:可濾出物質(zhì)允許限值的確定 |
(Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances ) |
| ANSI/AAMI/ISO 10993-2-1993 |
醫(yī)療器械的生物評(píng)定.第2部分:動(dòng)物保障要求 (收集在ANSI/AAMI/ISO 10993-93匯編集中) |
Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements (included in ANSI/AAMI/ISO 10993-1993: A collection) |
| ANSI/AAMI/ISO 10993-3-1993 |
醫(yī)療器械的生物評(píng)定.第3部分:基因毒性、致癌作用和生殖毒性的測(cè)試(收集在ANSI/AAMI/ISO 10993-93匯編集中) |
Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity (included in ANSI/AAMI/ISO 10993-1993: A collection) |
| ANSI/AAMI/ISO 10993-3-2003 |
醫(yī)療器械的生物評(píng)定.第3部分:基因毒性、致癌作用和生殖毒性的測(cè)試 |
(Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity (included in ANSI/AAMI/ISO 10993-1993: A collection) ) |
| ANSI/AAMI/ISO 10993-4-2002 |
醫(yī)療器械的生物評(píng)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 tests for interactions with blood ) |
| ANSI/AAMI/ISO 10993-7-1995 |
醫(yī)學(xué)器械的生物學(xué)評(píng)價(jià).第7部分:乙醇氧化物消毒殘?jiān)?/td>
| Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals |
| ANSI/AAMI/ISO 11134-1993 |
保健產(chǎn)品的消毒.確認(rèn)和例行控制的要求.工業(yè)濕熱消毒 (ANSI/AAMI ST25-87的修訂和更換代號(hào)) |
Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization |
| ANSI/AAMI/ISO 11135-1994 |
醫(yī)療器械.環(huán)氧乙烷消毒的確認(rèn)和例行控制 |
Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization |
| ANSI/AAMI/ISO 11137-1994 |
保健產(chǎn)品的消毒.確認(rèn)和例行控制的要求.輻射消毒 |
Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization |
| ANSI/AAMI/ISO 11137-1994/A1-2002 |
保健制品的滅菌.批準(zhǔn)和常規(guī)控制的要求.輻射滅菌 |
(Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization ) |
| ANSI/AAMI/ISO 11607-1997 |
滅菌醫(yī)療裝置的包裝 |
Packaging for Terminally Sterilized Medical Devices |
| ANSI/AAMI/ISO 11737-1-1995 |
醫(yī)療器械的消毒.微生物方法.第1部分:產(chǎn)品微生物群落數(shù)的估計(jì) |
Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of the Population of Microorganisms on Product |
| ANSI/AAMI/ISO 11737-3-2004 |
醫(yī)療器械的消毒.微生物方法.第3部分:生物負(fù)載數(shù)據(jù)的評(píng)估和解釋指南 |
|
| ANSI/AAMI/ISO 13485-1996 |
質(zhì)量體系.醫(yī)療裝置.ISO 9001應(yīng)用的特殊要求 |
Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001 |
| ANSI/AAMI/ISO 13485-2003 |
質(zhì)量體系.醫(yī)療器械.管理用系統(tǒng)要求 |
(Quality Management Systems - Medical Devices - System Requirements for Regulatory Purposes ) |
| ANSI/AAMI/ISO 13488-1996 |
質(zhì)量體系.醫(yī)療裝置.ISO 9002應(yīng)用的特殊要求 |
Quality Systems - Medical Devices - Particular Requirements for The Application of ISO 9002 |
| ANSI/AAMI/ISO 14155-1-2003 |
醫(yī)療器械的臨床調(diào)查 |
(Clinical Investigation of Medical Devices ) |
| ANSI/AAMI/ISO 14155-1996 |
醫(yī)療器械的臨床調(diào)查 |
Clinical Investigation of Medical Devices |
| ANSI/AAMI/ISO 14155-2-2003 |
醫(yī)療或?qū)嶒?yàn)對(duì)象用醫(yī)療器械的臨床調(diào)查.臨床調(diào)查計(jì)劃 |
(Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans ) |
| ANSI/AAMI/ISO 15223/A2-2004 |
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(hào).修改件2 |
|
| ANSI/AAMI/ISO 15225-A1-2004 |
命名.管理數(shù)據(jù)交換用醫(yī)療器械命名系統(tǒng)規(guī)范(修改件1).管理數(shù)據(jù)交換的提出 |
|
| ANSI/AAMI/ISO 25539-1-2003 |
心血管植入物.血管內(nèi)裝置.第1部分:血管內(nèi)修復(fù)裝置 |
(Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses ) |
| ANSI/AAMI/ISO 5840-1996 |
心血管植入.心臟瓣膜修復(fù) |
Cardiovascular Implants - Cardiac Valve Prostheses |
| ANSI/AAMI/ISO 5840-2005 |
心血管植入物.心臟瓣膜修復(fù) |
|
| ANSI/AAMI/ISO 7198-2001 |
血管移植物修復(fù)術(shù) |
Vascular Graft Prostheses |
| ANSI/AAMI/ISO 7199-1996 |
心血管植入和人造器官血液氣體交換器(氧氣器) |
Cardiovascular implants and artificial organs- Blood-gas exchangers (oxygenators) |
| ANSI/AAMI/sort/ISO/CEN 10993-12-1996 |
醫(yī)學(xué)器械的生物學(xué)評(píng)價(jià).第12部分:樣本制備和標(biāo)準(zhǔn)物質(zhì) |
Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials |
| ANSI/AASHTO/AWS D 1.5-1996 |
橋梁焊接規(guī)程 |
Bridge Welding Code |
| ANSI/ABMA 10A-2001 |
未磨過的軸承和其它用途的金屬珠 |
Metal Balls for Unground Bearings and Other Uses |
| ANSI/ABMA 12.1-1992 |
設(shè)備滾珠軸承.米制設(shè)計(jì) |
Instrument Ball Bearings - Metric Design |
| ANSI/ABMA 12.2-1992 |
設(shè)備滾珠軸承.英寸設(shè)計(jì) |
Instrument Ball Bearings - Inch Design |
| ANSI/ABMA 14-1995 |
球狀外部平面承載的房屋 |
Housings for Bearings with Spherical Outside Surfaces |
| ANSI/ABMA 15-1991 |
球形外表面和擴(kuò)展的內(nèi)環(huán)寬度的滾柱軸承 |
Ball Bearings with Spherical Outside Surfaces and Extended Inner Ring Width |
| ANSI/ABMA 16.1-1988 |
飛機(jī)機(jī)架滾珠、滾柱和滾針軸承結(jié)構(gòu)的米制設(shè)計(jì) |
Airframe Ball, Roller, and Needle Roller Bearings, Metric Design |
| ANSI/ABMA 18.1-1982 |
米制設(shè)計(jì)的徑向滾針軸承 |
Radial Needle Roller Bearings, Metric Design |
| ANSI/ABMA 18.2-1982 |
滾針軸承.徑向.英制設(shè)計(jì) |
Radial Needle Roller Bearings, Inch Design |
| ANSI/ABMA 19.2-1994 |
錐形滾柱軸承.徑向.英制設(shè)計(jì) |
Tapered Roller Bearings -- Radial - Inch Design |
| ANSI/ABMA 20-1996 |
球形,圓柱形輻射滾柱軸承類型.米制設(shè)計(jì) |
Radial Bearings of Ball, Cylindrical Roller, and Spherical Roller Types, Metric Design |
| ANSI/ABMA 21.1-1988 |
止推滾針軸承、保持器組件和止推墊圈.米制設(shè)計(jì) |
Thrust Needle Roller and Cage Assemblies and Thrust Washers - Metric Design |
| ANSI/ABMA 21.2-1988 |
止推滾針軸承、保持器組件和止推墊圈.英制設(shè)計(jì) |
Thrust Needle Roller and Cage Assemblies and Thrust Washers - Inch Design |
| ANSI/ABMA 22.2-1988 |
關(guān)節(jié)徑向軸承.連接型.英制設(shè)計(jì) |
Spherical Plain Radial Bearings, Joint Type, Inch Design |
| ANSI/ABMA 23.2-1988 |
英制設(shè)計(jì)的錐形滾柱止推軸承 |
Thrust Bearings of Tapered Roller Type, Inch Design |
| ANSI/ABMA 24.2-1989 |
英制設(shè)計(jì)的止推滾珠和圓筒形滾柱軸承 |
Thrust Bearings of Ball and Cylindrical Roller Types, Inch Design |
| ANSI/ABMA 25.2-1990 |
套筒式循環(huán)球線性運(yùn)動(dòng)滾柱軸承.英制系列 |
Rolling Bearings, Linear Motion, Recirculating Ball, Sleeve Type - Inch Series |
| ANSI/ABMA 26.2-1994 |
薄斷面滾珠軸承.英制設(shè)計(jì) |
Thin Section Ball Bearings - Inch Design |
| ANSI/ABMA 4-1994 |
滾球和滾柱軸承的公差定義和測(cè)量實(shí)施規(guī)程 |
Tolerance Definitions and Gaging Practices for Ball and Roller Bearings |
| ANSI/ABMA 7-1995 |
米制徑向球體和軸狀承載的柱身和房屋密接(錐形軸狀承載除外)(與基本平面圖相符合) |
Shaft and Housing Fits for Metric Radial Ball and Roller Bearings (Except Tapered Roller Bearings) Conforming to Basic Boundary Plan) |
| ANSI/ABMA/ISO 10285-1992 |
線性運(yùn)動(dòng)雙向滾珠套筒式滾柱軸承.米制系列 |
Rolling Bearings, Linear Motion, Recirculating Ball, Sleeve Type - Metric Series |
| ANSI/ABMA/ISO 3096-1998 |
滾柱軸承.滾針.尺寸和公差(米制設(shè)計(jì)) |
Rolling Bearings - Needle Rollers - Dimensions and Tolerances, Metric Design |
| ANSI/ABYC A-16-1998 |
電導(dǎo)航燈 |
Electric Navigation Lights |
| ANSI/ABYC A-28-1998 |
電絕緣子 |
Galvanic Isolators |
| ANSI/ABYC H-37-1995 |
小機(jī)動(dòng)船 |
Mini Jet Boats |
| ANSI/ABYC P-23-1995 |
小機(jī)動(dòng)船的掌舵和控制系統(tǒng) |
Steering and Control Systems for Mini Jet Boats |
| ANSI/ACCA 3Manual S-2004 |
住宅用設(shè)備選擇 |
|
| ANSI/ACCA 3Manual S-2004 |
住宅用設(shè)備選擇 |
|
| ANSI/ACCA ManJ 2-2004 |
住宅用加熱和制冷負(fù)載計(jì)算的標(biāo)準(zhǔn) |
|
| ANSI/ACDE 01-1993 |
潛水員培訓(xùn)最低標(biāo)準(zhǔn) |
Commercial Diver Training - Minimum Standards |
| ANSI/ACI 216.1-1997 |
測(cè)定混凝土和砂石結(jié)構(gòu)組件防火的標(biāo)準(zhǔn)方法 |
Standard Method for Determining Fire Resistance of Concrete and Masonry Construction Assemblies |
| ANSI/ACI 308-1992 |
混凝土養(yǎng)護(hù)規(guī)程 |
Practice for Curing Concrete |
| ANSI/ACI 318-1989 |
鋼筋混凝土建造規(guī)程要求 |
Building Code Requirements for Reinforced Concrete and Commentary |
| ANSI/ACI 530-1992 |
磚石結(jié)構(gòu)的建筑規(guī)程要求 |
Building Code Requirements for Masonry Structures |
| ANSI/ACMA/ICPA UEF-1-2004 |
敞口造型混合工藝的排放因素評(píng)估 |
|
| ANSI/ADA 1-1977 |
牙科用合金汞齊 |
Alloy for Dental Amalgam |
| ANSI/ADA 1-2003 |
牙科用汞和汞合金 |
(Alloy for Amalgam and Dental Mercury ) |
| ANSI/ADA 100-2004 |
正牙托架和管 |
|
| ANSI/ADA 1000-2001 |
電子醫(yī)療記錄的結(jié)構(gòu)和內(nèi)容的標(biāo)準(zhǔn)診療數(shù)據(jù)體系結(jié)構(gòu) |
Standard Clinical Data Architecture for the Structure and Content of an Electronic Health Record |
| ANSI/ADA 101-2001 |
牙根槽儀器.一般要求 |
Root Canal Instruments - General Requirements |
| ANSI/ADA 11-1997 |
瓊脂壓印材料 |
Agar Impression Materials |
| ANSI/ADA 12-1975 |
義齒基托聚合體 |
Denture Base Polymers |
| ANSI/ADA 12-2002 |
托牙基聚合物 |
(Denture Base Polymers ) |
| ANSI/ADA 13-1981 |
假牙冷凍治療修復(fù)樹脂 |
Denture Cold-Curing Repair Resin |
| ANSI/ADA 14-1982 |
牙科用鉻鈷澆鑄合金 |
Casting Alloy, Dental Chromium-Cobalt |
| ANSI/ADA 15a-1992 |
合成樹脂牙 |
Synthetic Resin Teeth |
| ANSI/ADA 16-1962 |
牙科用印模.氧化鋅正常型 |
Impression Paste, Dental-Zinc Oxide Eugenol Type |
| ANSI/ADA 17-1983 |
義齒基托臨時(shí)排列樹脂 |
Denture Base Temporary Relining Resins |
| ANSI/ADA 18-1992 |
藻酸鹽印模材料 |
Alginate Impression Materials |
| ANSI/ADA 19-1982 |
牙科材料.非含水的彈性壓印材料, |
Dental Materiel - Elastomeric Impression Material, Non-Aqueous |
| ANSI/ADA 19-2004 |
牙科學(xué).彈性印模材料 |
|
| ANSI/ADA 1a-1979 |
牙科用合金汞齊 |
Alloy for Dental Amalgam |
| ANSI/ADA 2-2002 |
牙科金合金用石膏粘結(jié)鑄造包埋材料 |
Gypsum-Bonded Casting Investment for Dental Gold Alloy |
| ANSI/ADA 20-1972 |
牙科用翻制材料 |
Dental Duplicating Material |
| ANSI/ADA 23-1982 |
牙科用挖鉆 |
Dental Excavating Burs |
| ANSI/ADA 23a-1984 |
牙科用挖鉆 |
Dental Excavating Burs |
| ANSI/ADA 24-1991 |
義齒基板蠟 |
Dental Baseplate Wax |
| ANSI/ADA 25-2000 |
牙科用X射線設(shè)備和附屬裝置 |
Dental X-ray Equipment and Accessory Devices |
| ANSI/ADA 26-1991 |
牙科X射線設(shè)備 |
Dental X-ray Equipment |
| ANSI/ADA 27-1993 |
牙科用直接填補(bǔ)樹脂 |
Dental Materiel - Direct Filling Resins |
| ANSI/ADA 28-2002 |
手持K型牙根管銼和擴(kuò)孔鉆 |
Root Canal Files and Reamers, Type K for Hand Use |
| ANSI/ADA 29-1976 |
牙科器械通用規(guī)范 |
Instruments, Dental; General Specifications |
| ANSI/ADA 3-1962 |
牙科用印模膏 |
Impression Compound, Dental |
| ANSI/ADA 30-1990 |
牙科用氧化鋅丁香粉和非丁香粉粘合劑 |
Dental Zinc Oxide-Eugenol Cements and Zinc Oxide Non-Eugenol Cements |
| ANSI/ADA 32-1977 |
不含貴金屬的正牙絲 |
Orthodontic Wires Not Containing Precious Metals |
| ANSI/ADA 33-1984 |
牙科術(shù)語 |
Dental Terminology |
| ANSI/ADA 33-2003 |
牙科術(shù)語 |
(Dental Terminology ) |
| ANSI/ADA 34-1978 |
牙科用抽吸式注射器 |
Dental Aspirating Syringes |
| ANSI/ADA 34a-1981 |
牙科用抽吸式注射器 |
Dental Aspirating Syringes |
| ANSI/ADA 37-1986 |
牙科用研磨粉 |
Dental Abrasive Powders |
| ANSI/ADA 39-1992 |
牙科用樹脂基溝和坑封閉劑 |
Dental Resin-Based Pit and Fissure Sealants |
| ANSI/ADA 4-1983 |
牙科用鑄造嵌體蠟 |
Dental Inlay Casting Wax |
| ANSI/ADA 41-1979 |
牙科材料生物評(píng)定 |
Biological Evaluation of Dental Materials |
| ANSI/ADA 42-2002 |
牙科磷酸鹽粘接鑄造包埋料 |
Dental Phosphate-Bonded Casting Investments |
| ANSI/ADA 43-1986 |
牙科用電動(dòng)混汞器 |
Electrically Powered Dental Amalgamators |
| ANSI/ADA 44-1979 |
牙科電動(dòng)手術(shù)設(shè)備 |
Dental Materiel - Electrosurgical Equipment |
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