| 編號 | 中文名稱 | 英文名稱 |
|---|---|---|
| NF C42-723-1996 | 測量、控制和試驗(yàn)室用電氣設(shè)備的安全要求.第723部分:醫(yī)療材料處理及實(shí)驗(yàn)室加工用蒸壓器的特殊要求 | (Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-041 : particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes.) |
| NF C42-724-1997 | 測量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求.第2-042部分:使用毒氣的實(shí)驗(yàn)室處理和醫(yī)療材料處理用高壓釜和消毒 | (Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 2-042 : particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes.) |
| NF C42-726-1997 | 測量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求.第2-043部分:使用熱空氣或熱惰性氣體的實(shí)驗(yàn)室處理和醫(yī)療材料處理 | (Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 2-043 : particular requirements for dry heat sterilizers using either hot air or inert gas for the treatment of medical materials, and for laboratory processes) |
| NF C42-739-2003 | 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.) |
| NF C52-558-2-15-2001 | 電力變壓器、供電裝置和類似設(shè)備的安全.第2-15部分:醫(yī)療場所供電隔絕變壓器的特殊要求 | (Safety of power transformers, power supply units and similar - Part 2-15 : particular requirements for isolating transformers for the supply of medical locations.) |
| NF C71-025-1995 | 照明設(shè)備.第2部分:特殊要求.第25節(jié):醫(yī)院和醫(yī)療保健中心臨床用燈具 | (Luminaires. Part 2 : particular requirements. Section 25 : luminaires for use in clinical areas of hospitals and health care buildings.) |
| NF C74-0102-1993 | 醫(yī)用電氣設(shè)備.醫(yī)療電器的安全.第1部分：一般規(guī)則.修改件2 | () |
| NF C74-012-1993 | 醫(yī)療電氣設(shè)備.第1部分:一般安全設(shè)備.附屬標(biāo)準(zhǔn)2:電磁兼容性.要求和試驗(yàn) | (Medical electrical equipment. Part 1 : general equipments for safety 2. Collateral standard : electromagnetic compatibility. Requirements an tests.) |
| NF C74-0131-1996 | 醫(yī)療電氣設(shè)備.第1部分:一般安全要求.附屬標(biāo)準(zhǔn)2:醫(yī)療電子設(shè)備系統(tǒng)的安全要求.補(bǔ)充件1 | () |
| NF C74-014-1994 | 醫(yī)療電氣設(shè)備.第1部分:安全的一般要求.第3節(jié):附屬標(biāo)準(zhǔn):X射線診斷設(shè)備輻射防護(hù)的一般要求 | (Medical electrical equipment. Part 1 : general requirements for safety 3. Collateral standard : general requirements for radiation protection in diagnostic X-ray equipment.) |
| NF C74-043-2003 | 有關(guān)活性(包括活性可植入)醫(yī)療產(chǎn)品制造業(yè)的標(biāo)準(zhǔn)EN 29001和EN 46001及EN 29002和EN 46002的應(yīng)用指南 | (Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry.) |
| NF C74-114-1992 | 電、熱特殊和醫(yī)療診斷用的旋轉(zhuǎn)陽極射線管的充電特性 | (Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis.) |
| NF C74-118-1993 | 醫(yī)用電氣設(shè)備.第2部分:醫(yī)療診斷設(shè)備用X射線源組件和X射線管組件的特殊安全要求 | (Medical electrical equipment. Part 2 : particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis.) |
| NF C74-122-1996 | 醫(yī)用電氣設(shè)備.第2部分:醫(yī)療診斷用磁共振設(shè)備安全特殊要求 | (Medical electrical equipment. Part 2 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.) |
| NF C74-122/A11-2000 | 醫(yī)療電氣設(shè)備.第2部分:醫(yī)療診斷用磁共振設(shè)備安全的特殊要求 | (Medical electrical equipment - Part 2 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.) |
| NF C74-134-1994 | 醫(yī)療放射科的評定和常規(guī)檢驗(yàn).第2-4部分:穩(wěn)定性試驗(yàn).硬拷貝攝影機(jī) | (Evaluation and routine testing in medical imaging departments. Part 2-4 : constancy tests. Hard copy cameras.) |
| NF C74-135-1994 | 醫(yī)療放射科的評定和常規(guī)檢驗(yàn).第2-5部分:穩(wěn)定性試驗(yàn).圖象顯示設(shè)備 | (Evaluation and routine testing in medical imaging departments. Part 2-5 : constancy tests. Image display devices.) |
| NF C74-136-1994 | 醫(yī)療放射科的評定和常規(guī)檢驗(yàn).第2-6部分:穩(wěn)定性試驗(yàn).計(jì)算機(jī)斷層攝影的X-射線設(shè)備 | (Evaluation and routine testing medical imaging departments. Part 2-6 : constancy tests. X-ray equipment for computed tomography.) |
| NF C74-152-1997 | 醫(yī)療放射科的評定和常規(guī)檢驗(yàn).第3-2部分:乳房X-射線照相設(shè)備的成象性能和驗(yàn)收試驗(yàn) | (Evaluation and routine testing in medical imaging departments. Part 3-2 : acceptance tests imaging performance of mammographic X-ray equipment.) |
| NF C74-153-1997 | 醫(yī)療放射科的評定和常規(guī)檢驗(yàn).第3-3部分:驗(yàn)收試驗(yàn).數(shù)字減法血管造影術(shù)(DSA)X-射線設(shè)備成像性能 | (Evaluation and routine testing in medical imaging departments. Part 3-3 : acceptance tests. Imaging performance of X-ray equipment for digital subtraction angiography (DSA).) |
| NF C74-201-1999 | 醫(yī)療電氣設(shè)備.第2-1部分:1-50MeV范圍內(nèi)電子加速器安全的特殊要求 | (Medical electrical equipment - Part 2-1 : particular requirements for the safety of electron accelerator in the range of 1 Mev to 50 Mev.) |
| NF C74-205-2002 | 醫(yī)療電氣設(shè)備.在放射治療中使用的帶電離室的劑量計(jì) | (Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy.) |
| NF C74-208/A1-2001 | 醫(yī)療電氣設(shè)備.醫(yī)療電子加速器.功能特性 | (Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.) |
| NF C74-210-1996 | 醫(yī)療電氣設(shè)備.第2部分:遠(yuǎn)程控制的自動(dòng)驅(qū)動(dòng)γ射線后裝設(shè)備安全的特殊要求 | (Medical electrical equipment - Part 2 : particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment.) |
| NF C74-214-1995 | 醫(yī)療電氣設(shè)備.放射性核素調(diào)整器.描述性能的特殊方法 | (Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance.) |
| NF C74-221-1994 | 醫(yī)療電氣設(shè)備.電光X射線圖象增強(qiáng)器的特性.第1部分:入口尺寸的測定 | (Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 1 : determination of the entrance field size.) |
| NF C74-222-1994 | 醫(yī)療電氣設(shè)備.電光X射線圖象增強(qiáng)器的特性.第2部分:變換系數(shù)的測定 | (Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 2 : determination of the conversion factor.) |
| NF C74-223-1994 | 醫(yī)療電氣設(shè)備. 電光X射線圖象增強(qiáng)器的特性.第3部分:亮度分配和亮度不均勻的測定(歐州標(biāo)準(zhǔn)61 262-3) | (Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 3 : determination of the luminance distribution and luminance non-uniformity.) |
| NF C74-224-1994 | 醫(yī)療電氣設(shè)備.電光X-射線圖象增強(qiáng)器的特性.第4部分:圖象失真的測定 | (Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 4 : determination of the image distorsion.) |
| NF C74-226-1994 | 醫(yī)療電氣設(shè)備.電光X射線圖象增強(qiáng)器的特性.第6部分:對比率和雜光指數(shù)的測定 | (Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 6 : determination of the contrast ratio and veiling glare index.) |
| NF C74-228-1-2002 | X射線醫(yī)療診斷保護(hù)裝置.第1部分:材料衰減特性的測定 | (Protective devices against diagnostic medical X-radiation - Part 1 : determination of attenuation properties of materials.) |
| NF C74-228-2-2002 | X射線醫(yī)療診斷保護(hù)裝置.第2部分:防護(hù)玻璃板 | (Protective devices against diagnostic medical X-radiation - Part 2 : protective glass plates.) |
| NF C74-308-1995 | 醫(yī)療電器設(shè)備.第2部分:具有內(nèi)部功率源的外部心臟起搏器的特殊安全要求 | (Medical electrical equipment. Part 2 : particular requirements for the safety of external cardiac pacemakers with internal power source.) |
| NF C74-318-1997 | 醫(yī)療電器設(shè)備.第2部分:內(nèi)診鏡檢查設(shè)備安全性的特殊要求 | (Medical electrical equipment. Part 2 : particular requirements for the safety of endoscopic equipment.) |
| NF C74-325-2003 | 醫(yī)療電氣設(shè)備.第2-41部分:外科和診斷照明設(shè)備的特殊安全要求 | (Medical electrical equipment - Part 2-41 : particular requirements for the safety of surgical luminaires and luminaires for diagnosis.) |
| NF C74-341-1996 | 醫(yī)療電氣設(shè)備.第2部分:診斷和治療用激光設(shè)備安全性特殊要求 | (Medical electrical equipment. Part 2 : particular requirements for the safety of diagnostic and therapeutic laser equipment.) |
| NF C74-372-1985 | 醫(yī)用電氣設(shè)備.微波醫(yī)療儀器.特殊安全規(guī)則 | (Electromedical equipment. Microwave therapy equipment. Particular safety requirements.) |
| NF C74-502-1-1998 | 可植入的有源醫(yī)療器件.第1部分:由制造商提供的安全性,標(biāo)識和信息的一般要求 | (Active implantable medical devices. Part 1 : general requirements for safety, marking and information to be provided by the manufacturer.) |
| NF C91-011/A1-1999 | 工業(yè)、科學(xué)和醫(yī)療用射頻設(shè)備的無線電干擾特性測量方法與限值 | (Industrial, scientific and medical (ISM) radio-frequency equipment - Radio disturbance characteristics - Limits and methods of measurement.) |
| NF C91-011/A2-2003 | 工業(yè)、科學(xué)和醫(yī)療(ISM)用射頻設(shè)備.無線電干擾特性.極限值和測量方法 | (Industrial, scientific and medical (ISM) radio-frequency equipment - Radio disturbance characteristics - Limits and methods of measurement.) |
| NF C97-904-1994 | 醫(yī)療診斷超聲波設(shè)備的聲輸出申報(bào)的要求 | (Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment.) |
| NF C97-907-1995 | 超聲領(lǐng)域.0.5MHz至15MHz范圍內(nèi)的液體中醫(yī)療超聲設(shè)備超聲功率的測量和特點(diǎn)指南 | (Ultrasonics fields. Guidance for the measurement and characterization of ultrasonic fields generate by medical ultrasonic equipment using hydrophones in the frequency range 0,5 MHz to 15 MHz.) |
| NF S64-021/A1-2003 | 醫(yī)療車輛及其設(shè)備.道路救護(hù)車 | (Medical vehicles and their equipment - Road ambulances.) |
| NF S90-010-1987 | 外科醫(yī)療器械.可重復(fù)使用的全玻璃或金屬和玻璃醫(yī)療注射器.第1部分:尺寸 | (Medico-surgical equipment. Reusable all-glass or metal-and-glass syringes for medical use. Part 1 : dimensions.) |
| NF S90-014-1981 | 外科醫(yī)療器械.可多次使用胰島素玻璃注射器 | (Medical and surgical equipment. Re-useable glass insulin syringes.) |
| NF S90-033-1986 | 外科醫(yī)療器械.多次用橡膠避孕套 | (MEDICO-SURGICAL EQUIPMENT. REUSABLE RUBBER CONTRACEPTIVE DIAPHRAGMS.) |
| NF S90-045-1985 | 外科醫(yī)療器械.制藥或配藥用鋁帽.驗(yàn)收檢驗(yàn) | (MEDICO-SURGICAL EQUIPMENT. ALUMINIUM CAPS FOR PHARMACEUTICAL USE. QUALITY ACCEPTANCE.) |
| NF S90-133-1989 | 外科醫(yī)療器械.外科手術(shù)用的輻射熱保溫箱.規(guī)范 | (MEDICO-SURGICAL EQUIPMENT. RADIANT INCUBATORS. SPECIFICATIONS.) |
| NF S90-191-1986 | 外科醫(yī)療器械.輸液用玻璃瓶.幾何特性及標(biāo)記 | (MEDICO-SURGICAL EQUIPMENT. GLASS BOTTLES FOR PERFUSION. GEOMETRICAL CHARACTERISTICS AND MARKING.) |
| NF S90-201-1990 | 外科醫(yī)療器械.輸血必需 | (Medico-surgical equipment. Transfusion sets.) |
| NF S90-202-1990 | 外科醫(yī)療器械.輸液必需 | (Medico-surgical equipment . Infusion sets.) |
| NF S90-203-1986 | 外科醫(yī)療器械.輸血和輸液傳送、加長和其它附屬裝置 | (MEDICO-SURGICAL EQUIPMENT. TRANSFER DEVICES,EXTENSION PIECES AND OTHER ANCILLARY EQUIPMENT FOR TRANSFUSION AND INFUSION.) |
| NF S90-221-1986 | 外科醫(yī)療器械.輸血器械.500ml玻璃瓶 | (Medico-surgical equipment. Transfusion equipment. 500 ml glass bottles.) |
| NF S90-222-1986 | 外科醫(yī)療器械.輸血器械.250ml玻璃瓶 | (Medico-surgical equipment. Transfusion equipment. 250 ml glass bottles.) |
| NF S90-230-1978 | 外科醫(yī)療器械.輸血器械.血及其制品用軟塑料簡式囊的尺寸和物理性能 | (MEDICAL AND SURGICAL EQUIPMENT. TRANSFUSION APPARATUS FOR MEDICAL USE. PHYSICAL AND DIMENSIONAL PROPERTIES OF SIMPLE FLEXIBLE PLASTIC BAGS FOR BLOOD AND ITS DERIVATIVES.) |
| NF S90-231-1978 | 外科醫(yī)療器械.醫(yī)用輸血器械.血及其制品用軟塑料簡式囊的尺寸和物理特性 | (MEDICAL AND SURGICAL EQUIPMENT. TRANSFUSION APPARATUS FOR MEDICAL USE. PHYSICAL AND DIMENSIONAL PROPERTIES OF MULTIPLE FLEXIBLE PLASTIC BAGS FOR BLOOD AND ITS DERIVATES.) |
| NF S90-240-1990 | 外科醫(yī)療器械.生物抽樣用一次性器皿.真空器皿 | (Medico-surgical equipment. Single-use containers for biological samples. Evacuated tubes.) |
| NF S90-251-1986 | 外科醫(yī)療器械.推力注射器.功能特性 | (MEDICO-SURGICAL EQUIPMENT. SYRINGE PUMPS. OPERATING CHARACTERISTICS.) |
| NF S90-304-1989 | 外科醫(yī)療器材.血液透析儀器.功能的特性 | (MEDICO-SURGICAL EQUIPMENT. HAEMODIALYSIS EQUIPMENT. OPERATING DATA.) |
| NF S90-305-1986 | 外科醫(yī)療器械.活膜滲析分布監(jiān)測器.功能特性 | (MEDICO-SURGICAL EQUIPMENT. PERITONEAL DIALYSIS CYCLER. FUNCTIONAL APTITUDE.) |
| NF S90-307-1990 | 外科醫(yī)療器械.細(xì)胞和血漿離心分離器(監(jiān)視器和一次性用品).工作性能 | (MEDICO-SURGICAL EQUIPMENT. CENTRIFUGE-TYPE BLOOD CELL AND PLASMA SEPARATORS (MONITORS AND SINGLE-USE KITS) SUITABILITY FOR USE.) |
| NF S90-312-1984 | 外科醫(yī)療器械.醫(yī)院用病床 | (BEDS FOR HOSPITAL USE.) |
| NF S90-316-1987 | 外科醫(yī)療器械.手術(shù)臺 | (MEDICO-SURGICAL EQUIPMENT. OPERATING TABLES.) |
| NF S90-321-1986 | 外科醫(yī)療器械.蒸氣消毒用包、套、軟片和卷筒尺寸 | (MEDICO-SURGICAL EQUIPMENT. BAGS,TUBE PACKINGS,SHEETS AND TOILS FOR STEAM-STERILIZATION. DIMENSIONS.) |
| NF S90-325-1989 | 外科醫(yī)療器械.蒸汽消毒器具 | (MEDICAL SURGICAL EQUIPMENT. STEAM DISINFECTING EQUIPMENT.) |
| NF S90-351-2003 | 醫(yī)療保健設(shè)施.清潔室和相關(guān)受控環(huán)境.空氣中污物的控制要求 | (Health care establishments - Cleanrooms and associated controlled environments - Requirements for the control of airbone contamination.) |
| NF S90-361-1990 | 外科醫(yī)療器械.釘子.股骨最高端用的不銹鋼片 | (MEDICO-SURGICAL EQUIPMENT. ROUGH-SURFACED STAINLESS STEEL NAIL PLATES FOR THE UPPER END OF THE THIGHBONE. MATERIALS AND DIMENSIONS.) |
| NF S90-408-1981 | 外科醫(yī)療器械.外科植入物.氧化鋁陶瓷制品 | (MEDICAL AND SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. CERAMIC MATERIALS BASED ON ALUMINA.) |
| NF S90-410-1988 | 外科醫(yī)療器械.外科植入物.接骨板.不對稱螺紋和可變底座（球形）板 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. GEOMETRY OF HOLES AND SLOTS CORRESPONDING TO SCREWS WITH ASYMMETRICAL THREAD AND SPHERICAL UNDER-SURFACES IN THE EQUIPMENT OF OSTEOSYNTHESIS.) |
| NF S90-411-1988 | 外科醫(yī)療器械.外科植入物.不對稱螺紋和球形底座的接骨用金屬螺釘.尺寸 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. OSTEOSYNTHESIS METAL SCREWS WITH ASYMMETRICAL THREAD AND SPHERICAL UNDER-SURFACE. DIMENSIONS.) |
| NF S90-414-1988 | 外科醫(yī)療器械.外科植入物.不對稱螺紋和球形底座接骨用不銹鋼螺絲.機(jī)械性能和試驗(yàn) | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. STAINLESS STEEL OSTEOSYNTHESIS SCREW WITH ASYMMETRICAL THREAD AND SPHERICAL FITTING. MECHANICAL REQUIREMENTS AND TESTING.) |
| NF S90-420-1986 | 外科醫(yī)療器械.外科植入物.骨髓腔內(nèi)插釘術(shù)系統(tǒng).第1部分:首蓿葉式或V型剖面的骨髓腔內(nèi)釘 | (Medico-surgical equipment. Implants for surgery. Intramedullary nailing systems. Part 1 : intramedullary nails with cloverleaf or V-shaped cross-section.) |
| NF S90-426-1988 | 外科醫(yī)療器械.外科植入物.不銹鋼粗糙面骨干板.尺寸和表面特性 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ROUGH SURFACE DIAPHYSIS PLATES MADE OF STAINLESS STEEL. DIMENSIONAL AND SURFACE CHARACTERISTICS.) |
| NF S90-427-1990 | 外科醫(yī)療器械.脊椎用接骨器材.不銹鋼制或鈷基合金制脊椎板.A系統(tǒng).尺寸與幾何形狀 | (MEDICO-SURGICAL EQUIPMENT. OSTEOSYNTHESIS EQUIPMENT FOR THE RACHIS. FORGED STAINLESS STELL OR COBALT ALLOY RACHIS PLATES. SYSTEM A. DIMENSIONS AND GEOMETRY.) |
| NF S90-433-1986 | 外科醫(yī)療器械.矯形外科設(shè)備.傳動(dòng)連接.第2部分:十字形和一字形旋具 | (Medico-surgical equipment. Orthopaedic instruments. Drive connections. Part 2 : screwdrivers for slotted, for cruciform and for recessed ned.) |
| NF S90-443-1989 | 外科醫(yī)療器械.外科植入物.嵌入胯骨中的人造大腿部件.嵌合物頂端部分和陽部分的規(guī)范 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. FEMORAL COMPONENTS OF HIP PROSTHESES WITH DETACHABLE HEAD. REQUIREMENTS FOR THE HEAD AND THE SPIGOT.) |
| NF S90-444-1987 | 外科醫(yī)療器械.外科植入物.局部和全部髖關(guān)節(jié)修復(fù)術(shù).第2部分: 由金屬和塑料材料制成的關(guān)節(jié)面 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. PARTIAL AND TOTAL HIP JOINT PROSTHESES. PART 2 : BEARING SURFACES MADE OF METALLIC AND PLASTICS MATERIALS.) |
| NF S90-445-1985 | 外科醫(yī)療器械.骨科關(guān)節(jié)假體.基本規(guī)范 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ORTHOPAEDIC JOINT PROSTHESES. BASIC REQUIREMENTS.) |
| NF S90-446-1985 | 外科醫(yī)療器械.膝關(guān)節(jié)全體和部分假肢.第1部分：分類、定義和尺寸名稱 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. PARTIAL AND TOTAL KNEE JOINT PROSTHESES. PART 1 : CLASSIFICATION,DEFINITIONS AND DESIGNATION OF DIMENSIONS.) |
| NF S90-449-1985 | 外科醫(yī)療器械.髖關(guān)節(jié)全部和部分假體.第1部分:分類和,尺寸的標(biāo)識和要求 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. PARTIAL AND TOTAL HIP JOINT PROSTHESES. PART 1 : CLASSIFICATION,DESIGNATION OF DIMENSIONS AND REQUIREMENTS.) |
| NF S90-460-1982 | 外科醫(yī)療器械.止血鉗.尺寸和試驗(yàn) | (MEDICAL AND SURGICAL EQUIPMENT. SURGICAL INSTRUMENTS. HAEMOSTATIC FORCEPS. DIMENSIONS AND TESTS.) |
| NF S90-461-1982 | 外科醫(yī)療器械.鉗、穿線管和持針器.尺寸和試驗(yàn) | (MEDICAL AND SURGICAL EQUIPMENT. SURGICAL INSTRUMENTS. FORCEPS,NEEDLE-THREADERS AND NEEDLE-HOLDERS. DIMENSIONS AND TESTS.) |
| NF S90-462-1982 | 外科醫(yī)療器械.一般用途.手術(shù)刀、解剖鑷、重復(fù)使用的手術(shù)刀、導(dǎo)管 | (MEDICAL AND SURGICAL EQUIPMENT. GENERAL PURPOSE SURGICAL INSTRUMENTS. KNIVES,DISSECTING TWEEZERS,RE-USEABLE BISTOURIES,PROBES.) |
| NF S90-463-1982 | 醫(yī)用外科設(shè)備.外科醫(yī)療器械.剪刀.尺寸和試驗(yàn) | (MEDICAL AND SURGICAL EQUIPMENT. SURGICAL INSTRUMENTS. SCISSORS. DIMENSIONS AND TESTS.) |
| NF S90-480-1987 | 外科醫(yī)療器械.外科植入物.心血管植入物、心臟瓣膜 | (MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. CARDIOVASCULAR IMPLANTS. CARDIAC VALVE PROSTHESES.) |
| NF S90-510-1973 | 外科醫(yī)療器械.矯形和假肢組件.肩軸和頸軸 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. SHOULDERED AND GROOVED PIN.) |
| NF S90-511-1973 | 外科醫(yī)療器械.矯形和假肢組件.帶凸耳的凸圓頭開槽全螺紋螺釘 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. JOINT SCREW WITH RAISED SLOTTED CHEESEHEAD. FULLY THREADED.) |
| NF S90-512-1973 | 外科醫(yī)療器械.矯形和假肢組件.帶凸耳的平圓頭開槽合螺紋螺釘 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. JOINT SCREW WITH FLAT SLOTTED CHEESEHEAD FULLY THREADED.) |
| NF S90-513-1973 | 外科醫(yī)療器械.矯形和假肢組件.帶安裝邊的凸圓頭半螺紋連接螺釘 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. JOINT SCREW WITH RAISED SLOTTED CHEESEHEAD AND FLANGE,PARTLY THREADED.) |
| NF S90-514-1973 | 外科醫(yī)療器械.矯形和假肢組件.凸耳凸圓頭鉚釘 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. SHOULDERED RIVET WITH RAISED CHEESE HEAD.) |
| NF S90-520-1973 | 外科醫(yī)療器械.矯形和假肢組件.帶連接掛鉤的可拆卸踝骨的連接 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. DETACHABLE ANKLE JOINT WITH ASSEMBLY HOOK.) |
| NF S90-521-1973 | 外科醫(yī)療器械.矯形和假肢組件.連接鉤 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. ASSEMBLY HOOK.) |
| NF S90-522-1973 | 外科醫(yī)療器械.矯形和假體組件.不可拆卸的單踝骨連接 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. FIXED ANKLE JOINT.) |
| NF S90-523-1973 | 外科醫(yī)療器械.矯形和假肢組件.不可拆卸的有套踝骨連接 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. FIXED ANKLE JOINT WITH FORK FITTING.) |
| NF S90-524-1973 | 外科醫(yī)療器械.矯形和假肢組件.無銷單膝的連接 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. KNEE JOINT WITHOUT BOLT.) |
| NF S90-525-1973 | 外科醫(yī)療器械.矯形和假肢組件.無銷、無滾珠軸承、有套膝骨的連接 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. KNEE JOINT WITH FORK FITTING,WITHOUT BALL-BEARINGS AND WITHOUT BOLT.) |
| NF S90-526-1973 | 外科醫(yī)療器械.矯形和假肢組件.帶滾珠軸承、無銷有套膝骨的連接 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. KNEE JOINT WITH FORK FITTING,BALL-BEARINGS AND WITHOUT BOLT.) |
| NF S90-527-1973 | 外科醫(yī)療器械.矯形和假肢組件.帶HOFFA銷釘單膝連接件 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. KNEE JOINT WITH HOFFA BOLT.) |
| NF S90-528-1973 | 外科醫(yī)療器械.矯形和假肢組件.帶HOFFA銷釘、無滾珠軸承、帶套膝的連接件 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. KNEE JOINT WITH FORK FITTING AND HOFFA BOLT,WITHOUT BALL-BEARINGS.) |
| NF S90-529-1973 | 外科醫(yī)療器械.矯形和假肢組件.無銷釘、無滾珠軸承、帶套臀部連接件 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. HIP JOINT WITH FORK FITTING,WITHOUT BALL-BEARINGS AND WITHOUT BOLT.) |
| NF S90-530-1973 | 外科醫(yī)療器械.矯形和假肢組件.HOFFA銷釘帶單臀部連接件 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. HIP JOINT WITH HOFFA BOLT.) |
| NF S90-531-1973 | 外科醫(yī)療器械.矯形和假肢組件.常HOFFA銷釘、無滾珠軸承：帶套臀部連接件 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. HIP JOINT WITH FORK FITTING AND HOFFA BOLT,WITHOUT BALL-BEARINGS.) |
| NF S90-532-1973 | 外科醫(yī)療器械.矯形和假肢組件.無銷釘帶滾珠有套臀部連接件 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. HIP JOINT WITH FORK FITTING AND BALL-BEARINGS,WITHOUT BOLT.) |
| NF S90-533-1973 | 外科醫(yī)療器械.矯形和假肢組件.帶套的HOFFA銷釘、無滾珠軸承有套臀部連接件 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. HIP JOINT WITH FORK FITTING,WITHOUT BALL-BEARINGS AND WITH FORKED HOFFA BOLT.) |
| NF S90-534-1973 | 外科醫(yī)療器械.矯形和假肢組件.單肘的連接件 | (MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. ELBOW JOINT.) |
| NF S90-550-1986 | 外科醫(yī)療器械.外部乳房假體 | (MEDICO-SURGICAL EQUIPMENT. EXTERNAL BREAST PROSTHESES.) |
| NF S91-160-1996 | 牙科學(xué).牙科用醫(yī)療裝置.牙科植入物 | (Dentistry. Medical devices for dentistry. Dental implants.) |
| NF S91-170-1996 | 牙科學(xué).牙科用醫(yī)療裝置.儀器 | (Dentistry. Medical devices for denstistry. Instruments.) |
| NF S91-200-1996 | 牙科學(xué).牙科用醫(yī)療裝置.材料 | (DENTISTRY. MEDICAL DEVICES FOR DENTISTRY. MATERIALS. (EUROPEAN STANDARD EN 1641).) |
| NF S91-224-1998 | 牙科工藝.用于牙科的醫(yī)療裝置的生物配伍性預(yù)診評估.牙科材料的試驗(yàn)方法 | (Dentistry. Preclinical evaluation of biocompatibility of medical devices used in dentistry. Test methods for dental materials.) |
| NF S91-300-1996 | 牙科學(xué).牙科用醫(yī)療裝置.設(shè)備 | (Dentistry. Medical devices for dentistry. Equipment.) |
| NF S92-019-1999 | 活體外醫(yī)療裝置.生物起源的樣品數(shù)量測量.參考測量過程展示(歐洲標(biāo)準(zhǔn)EN 12286) | (IN VITRO MEDICAL DEVICES. MEASUREMENTS OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN. PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES. (EUROPEAN STANDARD EN 12286).) |
| NF S92-019/A1-2000 | 活體外診斷醫(yī)療裝置.生物起源的樣品數(shù)量測量.參考測量過程展示 | (In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures.) |
| NF S92-021-2004 | 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.) |
| NF S92-022-2004 | 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 to calibrators and control m) |
| NF S92-024-2002 | 自測用體外診斷醫(yī)療裝置的一般要求 | (General requirements for in vitro diagnostic medical devices for self-testing.) |
| NF S92-025-2002 | 在實(shí)驗(yàn)室條件下診斷醫(yī)療裝置的性能評估 | (Performance evaluation of in vitro diagnostic medical devices.) |
| NF S92-031-1996 | 體外診斷系統(tǒng).體外診斷醫(yī)療裝置用EN 29001、EN 46001、EN 29002和EN 46002的應(yīng)用指南 | (In vitro diagnostic systems. Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices.) |
| NF S92-033-2003 | 體外診斷醫(yī)療設(shè)備的驗(yàn)收試驗(yàn)用抽樣程序.統(tǒng)計(jì)方面 | (Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.) |
| NF S92-040-1999 | 活體外診斷醫(yī)療裝置.用生物染色的體外診斷試劑生產(chǎn)提供的信息 | (IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY. (EUROPEAN STANDARD EN 12376).) |
| NF S92-051-1999 | 實(shí)驗(yàn)室診斷醫(yī)療裝置.微生物用培養(yǎng)基.培養(yǎng)基的性能標(biāo)準(zhǔn) | (In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media.) |
| NF S92-051/A1-2002 | 實(shí)驗(yàn)室診斷醫(yī)療裝置.微生物用培養(yǎng)基.培養(yǎng)基的性能標(biāo)準(zhǔn) | (In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media.) |
| NF S93-004-1995 | 醫(yī)療器件制造用不銹鋼針頭管材 | (STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE O FMEDICAL DEVICES. (EUROPEAN STANDARD EN ISO 9626).) |
| NF S93-004/A1-2001 | 醫(yī)療裝置生產(chǎn)用不銹鋼針管 | (Stainless steel needle tubing for the manufacture of medical devices.) |
| NF S93-011-1993 | 注射管、注射針及其它醫(yī)療設(shè)備用的6％錐的錐形配件:第1部分:一般要求 | (Conical fittings with a 6 per cent (luer) taper for syringes, needles and certain other medical equipment. Part 1 : general requirements.) |
| NF S93-012-1997 | 注射器,注射針頭和一定的其它醫(yī)療器械用A6%(路厄氏)錐度的錐形附件.鎖定附件 | (Conical fittings with a 6 % (LUER) taper for syringes, needles and certain other medical equipment. Lock fittings.) |
| NF S94-090-2001 | 醫(yī)療外科設(shè)備.骨外科輔助定位裝置用材料.馬氏體不銹鋼、彌散硬化不銹鋼、奧氏體不銹鋼和奧氏鐵素體不銹鋼 | (Medico-surgical equipment - Materials for ancillary positioning instruments for bone surgery - Martensitic, precipitation hardening, austenitic and austeno-ferritic stainless steels.) |
| NF S94-113-1996 | 外科植入物.骨銷和線.第1部分:材料和醫(yī)療設(shè)備 | (Implants for surgery. Skeletal pins and wires. Part 1 : material and mechanical requirements.) |
| NF S94-472-2002 | 外科和牙醫(yī)用醫(yī)療器械.測定抗高壓鍋消毒、腐蝕和熱暴露的耐力 | (Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure.) |
| NF S95-151-2001 | 醫(yī)療抽吸設(shè)備.第1部分:電動(dòng)抽吸設(shè)備.安全要求 | (Medical suction equipment - Part 1 : electrically powered suction equipment - Safety requirements.) |
| NF S95-152-2001 | 醫(yī)療抽吸設(shè)備.第2部分:手動(dòng)抽吸設(shè)備 | (Medical suction equipment - Part 2 : manually powered suction equipment.) |
| NF S95-153-2001 | 醫(yī)療抽吸設(shè)備.第3部分:真空或壓力源驅(qū)動(dòng)的抽吸設(shè)備 | (Medical suction equipment - Part 3 : suction equipment powered from a vacuum or pressure source.) |
| NF S95-156-1997 | 醫(yī)療電氣設(shè)備.用于人的煙密度計(jì).特殊要求 | (Medical electrical equipment. Capnometers for use with humans. Particular requirements.) |
| NF S95-159-1997 | 與醫(yī)療麻醉劑一起使用的壓力調(diào)節(jié)器.第1部分:壓力調(diào)節(jié)器和帶流量測量裝置的壓力調(diào)節(jié)器(歐洲標(biāo)準(zhǔn)EN 738-1) | (PRESSURE REGULATORS FOR USE WITH MEDICAL GASES. PART 1 : PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES. (EUROPEAN STANDARD EN 738-1).) |
| NF S95-179/A1-2002 | 醫(yī)用氣體壓力調(diào)節(jié)器.第4部分:裝入醫(yī)療設(shè)備的低壓調(diào)節(jié)器 | (Pressure regulators for use with medical gases - Part 4 : low-pressure regulators intended for incorporation into medical equipment.) |
| NF S95-202-2003 | 航空、水域和復(fù)雜地形用救護(hù)車.第1部分:連續(xù)救護(hù)患者用醫(yī)療器械接口要求 | (Air, water and difficult terrain ambulances. Part 1 : medical device interface requirements for the continuity of patient care.) |
| NF S97-002-2001 | 一次性醫(yī)療手套.第2部分:物理性能的要求和檢驗(yàn)方法 | (Medical gloves for single use - Part 2 : requirements and testing for physical properties.) |
| NF S97-122-3-2003 | 非放射性醫(yī)療器械.主要傷口敷料試驗(yàn)方法.第3部分:防水性 | (Non-active medical devices - Test methods for primary wound dressings - Part 3 : waterproofness.) |
| NF S97-122-4-2003 | 非放射性醫(yī)療器械.主要傷口敷料試驗(yàn)方法.第4部:合格性 | (Non-active medical devices - Test methods for primary wound dressings - Part 4 : conformability.) |
| NF S97-122-6-2003 | 非放射性醫(yī)療器械.主要傷口敷料試驗(yàn)方法.第6部分:氣味控制 | (Non-active medical devices - Test methods for primary wound dressings - Part 6 : odour control.) |
| NF S97-165-1-2003 | 病人、醫(yī)務(wù)人員和醫(yī)療設(shè)備做為醫(yī)療用品使用的手術(shù)蓋單、長外衣、無污染套裝.制造商、加工者及產(chǎn)品的一般要 | (Surgical drapes, growns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1 : general requirements for manufacturers, processors and products.) |
| NF S97-317/A1-2002 | 支承醫(yī)療設(shè)備的支架系統(tǒng) | (Rail systems for supporting medical equipment.) |
| NF S97-500-2003 | 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.) |
| NF S97-530-2002 | 醫(yī)療信息學(xué).有關(guān)輸血的信息.通訊和數(shù)據(jù)模型 | (Medical informatics - Messages concerning blood transfusion - Communication and data model.) |
| NF S97-531-2002 | 醫(yī)療信息學(xué).有關(guān)輸血的信息.指定的供血信息和指定的供血信息報(bào)告 | (Medical informatics - Messages concerning blood transfusion - Nominative delivery message and report on nominative delivery message.) |
| NF S97-532-2002 | 醫(yī)療信息學(xué).有關(guān)輸血的信息.易變血液產(chǎn)品供給信息 | (Medical informatics - Messages concerning blood transfusion - Labile blood product delivery message.) |
| NF S97-543-1998 | 護(hù)理信息學(xué).聯(lián)合國標(biāo)準(zhǔn)化信息.醫(yī)療設(shè)備的成本和使用 | (HEALTHCARE INFORMATICS. UNITED NATIONS STANDARDIZED MESSAGE. COST AND IMPLEMENTATION OF MEDICAL RESSOURCES (MEDRUC).) |
| NF S97-601-1-2000 | 醫(yī)療設(shè)備制造用動(dòng)物組織及其衍生物.第1部分:風(fēng)險(xiǎn)分析和管理 | (Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1 : analysis and management of risk.) |
| NF S97-601-2-2000 | 醫(yī)療設(shè)備制造用動(dòng)物組織及其衍生物.第2部分:資源控制、采集和輸送 | (Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2 : controls on sourcing, collection and handling.) |
| NF S97-601-3-2000 | 醫(yī)療設(shè)備制造用動(dòng)物組織及其衍生物.第3部分:病毒和其它傳染劑的清除和/或僵化的證實(shí) | (Animal tissues et their derivatives utilized in the manufacture of medical devices - Part 3 : validation of the elimination and/or inactivation of viruses and other transmissible agents.) |
| NF S98-051-1997 | 已消毒醫(yī)療設(shè)備用包裝材料和系統(tǒng).第1部分:一般要求和試驗(yàn)方法 | (Packaging materials and systems for medical devices which are to be sterilized. Part 1 : general requirements and test methods.) |
| NF S98-051-2-1999 | 已消毒醫(yī)療設(shè)備用包裝材料和系統(tǒng).第2部分:消毒的包裹物.要求和試驗(yàn)方法 | (PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 2 : STERILIZATION WRAP. REQUIREMENTS AND TEST METHODS. (EUROPEAN STANDARD EN 868-2).) |
| NF S98-051-3-1999 | 要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第3部分:小袋和卷軸生產(chǎn)及紙袋生產(chǎn)用紙.要求和試驗(yàn)方法 | () |
| NF S98-051-4-1999 | 要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第4部分:要求和試驗(yàn)方法 | (PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 4 : PAPER BAGS. REQUIREMENTS AND TEST METHODS. (EUROPEAN STANDARD EN 868-4).) |
| NF S98-051-5-1999 | 要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第5部分:加熱封閉和可自封閉的紙及塑料薄膜結(jié)構(gòu)的袋和卷軸.要求和試驗(yàn)方 | (Packaging materials and systems for medical devices which are to be sterilized - Part 5 : heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods.) |
| NF S98-051-6-1999 | 要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第6部分:醫(yī)療上用環(huán)氧乙烷或輻照消毒用紙袋的生產(chǎn)用紙.要求和試驗(yàn)方法. | (PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 6 : PAPER FOR THE MANUFACTURE OF PACKS FOR MEDICAL USE FOR STERILIZATION BY ETHYLENE OXIDE OR IRRADIATION. REQUIREMENTS AND TEST METHODS. (EUROPEAN STANDARD EN 868-6).) |
| NF S98-051-7-1999 | 要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第7部分:醫(yī)療上用環(huán)氧乙烷或輻照消毒用熱封閉袋的生產(chǎn)用粘貼涂覆紙.要求 | () |
| NF S98-051-8-1999 | 要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第8部分:與EN285一致的蒸氣消毒器用可再使用的消毒容器.要求和試驗(yàn)方法 | (Packaging materials and systems for medical devices which are to be sterilized. Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods.) |
| NF S98-059-2000 | 要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第9部分:加熱密封袋、卷軸和蓋用未涂覆非織造聚烯烴材料.要求和試驗(yàn)方法 | (Packaging materials and systems for medical devices which are to be sterilized - Part 9 : uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lid) |
| NF S98-060-2000 | 要消毒的醫(yī)療設(shè)備用包裝材料和系統(tǒng).第10部分:加熱密封袋、卷軸和蓋用膠粘涂覆非織造聚烯烴材料.要求和試驗(yàn) | (Packaging materials and systems for medical devices which are to be sterilized - Part 10 : adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels) |
| NF S98-100-2002 | 醫(yī)療保健產(chǎn)品的消毒.生物指示器.結(jié)果的選擇、使用和解釋的指南 | (Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results.) |
| NF S98-101-1994 | 醫(yī)療器械的殺菌.環(huán)氧乙烷殺菌的確認(rèn)和常規(guī)控制方法.要求 | (STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION. (EUROPEAN STANDARD EN 550).) |
| NF S98-103-1994 | 醫(yī)療器械的殺菌.輻射殺菌的確認(rèn)和常規(guī)控制方法.要求(EN 552) | (STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION. (EUROPEAN STANDARD EN 552).) |
| NF S98-103/A2-2001 | 醫(yī)療裝置的消毒.通過輻射對消毒的常規(guī)控制和檢驗(yàn) | (Sterilization of medical devices - Validation and routine control of sterilization by irradiation.) |
| NF S98-105-1994 | 醫(yī)療器械的殺菌.蒸汽殺菌的確認(rèn)和常規(guī)控制方法 | (STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT. (EUROPEAN STANDARD EN 554).) |
| NF S98-107-1-2002 | 醫(yī)療器械的消毒.對被標(biāo)記“消毒“的醫(yī)療器械的要求.第1部分:對經(jīng)終端消毒的醫(yī)療器械的要求 | (Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices.) |
| NF S98-109-2-1997 | 醫(yī)療器械的殺菌.微生物菌群制品的確認(rèn).第2部分:導(dǎo)則 | (Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 2 : guidance.) |
| NF S98-110-3-1997 | 醫(yī)療器械的殺菌.微生物菌群制品的確認(rèn).第3部分:微生物技術(shù)批準(zhǔn)方法導(dǎo)則 | (Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 3 : guide to the methods for validation of microbiological techniques.) |
| NF S98-115-2001 | 保健產(chǎn)品的消毒.醫(yī)療設(shè)備消毒方法的制定、確認(rèn)和常規(guī)控制及消毒劑特性的通用標(biāo)準(zhǔn) | (Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilizing process for medical device) |
| NF S98-118-2-2000 | 醫(yī)療設(shè)備的消毒.微生物法.第2部分:消毒過程鑒定所做的無菌實(shí)驗(yàn) | (Sterilisation of medical devices - Microbiological methods - Part 2 : tests of sterility performed in the validation of a sterilization process.) |
| NF S99-003-1998 | 制造商提供的醫(yī)療裝置信息 | (Information supplied by the manufacturer with medical devices.) |
| NF S99-004-1996 | 醫(yī)療裝置標(biāo)簽中使用的圖形符號 | (Graphical symbols for use in the labelling of medical devices.) |
| NF S99-004/A1-1999 | 醫(yī)療器械標(biāo)簽用圖形符號 | (Graphical symbols for use in the labelling of medical devices.) |
| NF S99-012-2000 | 命名法.規(guī)定數(shù)據(jù)交換用醫(yī)療設(shè)備命名系統(tǒng)規(guī)范 | (Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange.) |
| NF S99-101-2001 | 質(zhì)量系統(tǒng).醫(yī)療設(shè)備.EN ISO 9001應(yīng)用的特殊要求 | (Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001.) |
| NF S99-102-1996 | 質(zhì)量體系.醫(yī)療設(shè)備.EN ISO 9002使用的特殊要求(歐洲標(biāo)準(zhǔn)EN 46002) | (Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002.) |
| NF S99-110-1995 | 非放射性醫(yī)療器械用EN 29001、EN 46001、EN 29002和EN 46002的應(yīng)用導(dǎo)則 | (Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices.) |
| NF S99-172-2003 | 醫(yī)療設(shè)備的使用.與保健人員對醫(yī)療設(shè)備的使用相關(guān)的風(fēng)險(xiǎn)管理 | (Use of medical devices - Risk management relative to the use of medical devices in health care establishments.) |
| NF S99-201-1-2003 | 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.) |
| NF S99-201-1993 | 人用醫(yī)療器械的臨床研究 | (Clinical investigation of medical devices for human subjects.) |
| NF S99-201-2-2003 | 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)查計(jì)劃 | (Clinical investigation of medical devices for human subjects - Part 2 : Clinical investigation plans.) |
| NF S99-211-2001 | 醫(yī)療裝置.醫(yī)療裝置風(fēng)險(xiǎn)管理應(yīng)用 | (Medical devices - Application of risk management to medical devices.) |
| NF S99-301-1995 | 醫(yī)療設(shè)備.電報(bào)警信號 | (Medical devices. Electrically generated alarm signals.) |
| NF S99-501-1998 | 生物學(xué)評估和醫(yī)療裝置.評估和試驗(yàn) | (Biological evaluation of medical devices. Part 1 : evaluation and testing.) |
| NF S99-502-1998 | 醫(yī)療裝置的生物評定.第2部分:動(dòng)物平安要求 | (Biological evaluation of medical devices. Part 2 : animal welfare requirements.) |
| NF S99-503-1994 | 醫(yī)療裝置生物學(xué)評定.第503部分:遺傳毒性、致癌力和生殖毒性試驗(yàn) | (Biological evaluation of medical devices. Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.) |
| NF S99-504-1994 | 醫(yī)療裝置生物學(xué)評定.第4部分:與血液相互作用試驗(yàn)選擇 | (Biological evaluation of medical devices. Part 4 : selection of tests for interactions with blood.) |
| NF S99-505-5-1999 | 醫(yī)療器械的生物評定.第5部分:細(xì)胞毒性試驗(yàn).玻璃試管法 | (Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.) |
| NF S99-506-1995 | 醫(yī)療裝置生物學(xué)評定.第6部分:植入后局部作用試驗(yàn) | (Biological evaluation of medical devices. Part 6 : tests for local effects after implantation.) |
| NF S99-507-1996 | 醫(yī)療裝置生物學(xué)評定.第7部分:環(huán)氧乙烷消毒殘余物 | (Biological evaluation of medical devices. Part 7 : ethylene oxide sterilization residuals.) |
| NF S99-508-2001 | 醫(yī)療器械的生物評定.第8部分:生物試驗(yàn)用參考材料的選擇和合格證明 | (Biological evaluation of medical devices - Part 8 : selection and qualification of reference materials for biological tests.) |
| NF S99-509-1999 | 醫(yī)療裝置的生物評定.第9部分:潛在降解產(chǎn)品鑒定和量化框架 | (Biological evaluation of medical devices. Part 9 : framework for identification and quantification of potential degradation products.) |
| NF S99-510-2003 | 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.) |
| NF S99-511-1996 | 醫(yī)療裝置的生物評定.第11部分:系統(tǒng)毒性試驗(yàn) | (Biological evaluation of medical devices. Part 11 : tests for systemic toxicity.) |
| NF S99-512-1997 | 醫(yī)療器械的生物評定.第12部分:樣品制備和參考材料 | (Plastics. Phenolic resins. Definitions and test methods.) |
| NF S99-513-1999 | 醫(yī)療器械的生物評定.第13部分:聚合醫(yī)療器械中老化產(chǎn)品的識別與量化 | (Biological evaluation of medical devices. Part 13 : identification and quantification of degradation products from polymeric medical devices.) |
| NF S99-514-2002 | 醫(yī)療器械的生物評定.第14部分:陶瓷降解產(chǎn)品的識別與合格鑒定 | (Biological evaluation of medical devices - Part 14 : identification and quantification of degradation products from ceramics.) |
| NF S99-515-2001 | 醫(yī)療器械的生物評定.第15部分:對從金屬和合金中降解的產(chǎn)品的識別和合格檢驗(yàn) | (Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys.) |
| NF S99-516-1997 | 醫(yī)療裝置的生物評定.第16部分:降解產(chǎn)品和可濾清物的毒理動(dòng)力學(xué)研究設(shè)計(jì)方法 | (Biological evaluation of medical devices. Part 16 : toxicokinetic study design for degradation products and leachables.) |
| NF S99-517-2003 | 醫(yī)療器械的生物評定.第17部分:可慮取物質(zhì)容許限值的確定 | (Biological evaluation of medical devices - Part 17 : establishment of allowable limits for leachable substances.) |
| NF T72-502-1997 | 化學(xué)消毒劑和防腐劑.醫(yī)療衛(wèi)生時(shí)手消毒法.試驗(yàn)方法和要求(第2階段/第2步) | (Chemical disinfectants and antiseptics. Hygienic handrub. Test method and requirements (phase2/step 2).) |
| NF X30-502-2003 | 醫(yī)療保健廢棄物的封裝.牙科汞齊廢棄物封裝.試驗(yàn)和規(guī)范 | (Packaging for medical care waste - Dental amalgam waste packaging - Tests and specifications.) |
| NF X30-510-2003 | 醫(yī)療保健廢棄物的術(shù)語 | (Terminology of health care waste.) |
| NF Z15-601-1996 | 機(jī)讀卡.醫(yī)療保健應(yīng)用.卡片:一般特征 | (MACHINE READABLE CARDS. HEALTH CARE APPLICATIONS. CARDS : GENERAL CHARACTERISTICS. (EUROPEAN STANDARD EN 1387).) |
| NF Z84-839-2-2003 | 電信.電磁兼容性和無線電頻譜管理(ERM).超低功率活性醫(yī)療植入物和附件用頻率范圍402MHz-405MHz的無線電設(shè)備 | () |
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