| 編號 | 中文名稱 | 英文名稱 |
|---|---|---|
| EN 12286-1998+A1-2000 | 體外診斷醫(yī)療器械 生物起源樣品中數(shù)量的測量 標準測量程序表達 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures |
| EN 12287-1999 | 體外診斷醫(yī)療器械 生物起源樣品中數(shù)量的測量 標準物質(zhì)描述 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials |
| EN 12306-1997 | 生物技術(shù) 農(nóng)業(yè)、植物和動物病蟲害控制和環(huán)境污染中使用的診斷盒質(zhì)量控制指南 | Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination |
| EN 12322-1999+A1-2001 | 體外診斷醫(yī)療器械 微生物學(xué)用培養(yǎng)基 培養(yǎng)基的性能標準 | In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
| EN 12376-1999 | 體外診斷醫(yī)療器械 由制造商提供的有關(guān)生物學(xué)染色用體外診斷劑的信息 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| EN 13532-2002 | 自檢用體外診斷醫(yī)療設(shè)備的一般要求 | General requirements for in vitro diagnostic medical devices for self-testing |
| EN 13612-2002+AC-2002 | 體外診斷醫(yī)療設(shè)備性能評估 | Performance evaluation of in vitro diagnostic medical devices |
| EN 13640-2002 | 體外診斷劑的穩(wěn)定性試驗 | Stability testing of in vitro diagnostic reagents |
| EN 13641-2002 | 消除或減少與體外診斷劑相關(guān)的傳染風險 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
| EN 13975-2003 | 體外診斷用醫(yī)療設(shè)備驗收試驗的取樣方法 統(tǒng)計法 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
| EN 1658-1996 | 試管診斷儀器的標度要求 | Requirements for marking of in vitro diagnostic instruments |
| EN 1659-1996 | 試管診斷系統(tǒng) 微生物的培養(yǎng)基 術(shù)語和定義 | In vitro diagnostic systems - Culture media for microbiology - Terms and definitions |
| EN 375-2001 | 制造商提供的專業(yè)用試管診斷試劑信息 | Information supplied by the manufacturer with in vitro diagnostic reagents for professional use |
| EN 376-2002 | 制造商提供的自測試用試管診斷試劑信息 | Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing |
| EN 591-2001 | 專業(yè)人員用試管診斷儀器使用說明書 | Instructions for use for in vitro diagnostic instruments for professional use |
| EN 592-2002 | 自測試用試管診斷儀器使用說明書 | Instructions for use for in vitro diagnostic instruments for self-testing |
| EN 60336-1995 | 醫(yī)用診斷裝置X射線管組件 聚焦特性 | X-ray tube assemblies for medical diagnosis - Characteristics of focal spots (IEC 60336:1993) |
| EN 60406-1997 | 醫(yī)用診斷X射線暗盒 X射線攝影盒與乳腺攝影暗盒 | Cassettes for medical X-ray diagnosis - Radiographic cassettes and mammographic cassettes (IEC 60406:1997) |
| EN 60601-1-3-1994 | 醫(yī)用電氣設(shè)備 第1部分：安全通用要求 并列標準 X射線診斷設(shè)備的輻射防護的一般要求 | Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:1994) |
| EN 60601-2-22-1996 | 醫(yī)療電氣設(shè)備 第2－22部分：診斷和治療用激光設(shè)備安全的特殊要求 | Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995) |
| EN 60601-2-28-1993 | 醫(yī)用電氣設(shè)備 第2－28部分：醫(yī)療診斷用X射線源組件和X射線管組件規(guī)范 | Medical electrical equipment; part 2-28: particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:1993) |
| EN 60601-2-33-2002 | 醫(yī)療電氣設(shè)備 第2－33：部分：醫(yī)療診斷用磁共振設(shè)備安全專用規(guī)范 | Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002) / Note: Endorsement notice |
| EN 60601-2-37-2001 | 醫(yī)療電氣設(shè)備 第2－37部分：超聲醫(yī)療診斷和監(jiān)護設(shè)備安全的特殊要求 | Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2001) |
| EN 60601-2-41-2000 | 醫(yī)療電氣設(shè)備 第2－41部分：外科手術(shù)燈和診斷用燈光的安全專用要求 | Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2000) |
| EN 60601-2-7-1998 | 醫(yī)療電氣設(shè)備 第2－7部分：診斷X射線發(fā)生裝置的高壓發(fā)生器安全專用要求 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998) |
| EN 60613-1990 | 醫(yī)用診斷旋轉(zhuǎn)陽極Ｘ射線管的電、熱和負載特性 | Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis |
| EN 60627-2001 | 診斷用Ｘ－射線 成像設(shè)備 通用和大圖形防散射濾柵的特征 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001) |
| EN 61010-2-101-2002 | 測量、控制和實驗室用電氣設(shè)備的安全要求 第2-101部分：生物體外診斷(IVD)醫(yī)療設(shè)備的特殊要求 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2002, modified) |
| EN 61157-1994 | 對醫(yī)療超聲波診斷設(shè)備聲輸出的要求 | Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:1992) |
| EN 61267-1994 | 醫(yī)用診斷X射線設(shè)備 測定特性用輻射條件 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics (IEC 61267:1994) |
| EN 61331-1-2002 | 醫(yī)用診斷X射線輻射防護器具 第1部分：材料衰減性能的測定 | Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials (IEC 61331-1:1994) |
| EN 61331-2-2002 | 醫(yī)用診斷X射線輻射防護器具 第2部分：防護玻璃板 | Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates (IEC 61331-2:1994) |
| EN 61331-3-1999 | 醫(yī)用診斷X射線輻射防護器具 第3部分：防護服和性腺防護器具 | Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads (IEC 61331-3:1998) |
| EN 61674-1997+A1-2002 | 醫(yī)用電氣設(shè)備 用于X射線診斷成像中帶電離室和/或半導(dǎo)體探測器的劑量儀 | Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnosis imaging (IEC 61674:1997) |
| EN 61676-2002 | 醫(yī)療電氣設(shè)備 用于診斷放射線學(xué)中X射線管電壓非發(fā)病測量的劑量測定儀 | Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002) / Note: Endorsement notice |
| EN 61953-1998 | X射線圖像診斷設(shè)備 乳腺攝影防散性濾線柵特性 | Diagnostic X-ray imaging equipment - Characteristics of mammographic anti-scatter grids (IEC 61953:1997) |
| EN 829-1996 | 玻璃試管內(nèi)的診斷系統(tǒng) 醫(yī)學(xué)和生物試樣的傳送包裝 要求、試驗 | In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements, tests |
| EN 928-1995 | 玻璃試管診斷系統(tǒng) 關(guān)于玻璃試管診斷醫(yī)療設(shè)備的EN 29001、EN 46001、EN 29002、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 |
| EN ISO 15197-2003 | 體外診斷檢查系統(tǒng) 控制糖尿病自查用血糖監(jiān)控系統(tǒng)的要求 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) |
| EN ISO 17511-2003 | 體外診斷醫(yī)療裝置 生物樣品的定量測量 已知校正器及控制材料值的計量跟蹤性 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
| EN ISO 18153-2003 | 體外診斷醫(yī)療裝置 生物樣品的定量測量 用已知校準器和控制材料確定酶中催化劑濃度值的計量可跟蹤性 | 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 materials (ISO 18153:2003) |
| HD 513 S1-1989 | 醫(yī)療診斷用最大旋轉(zhuǎn)陽極X射線管對稱輻射場的測定 | Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis |
| prEN 14254-2001 | 體外診斷醫(yī)療設(shè)備 除血液外從人體采集的樣品一次性貯存容器 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| prEN 61681-1-2000 | 超聲學(xué) 場安全 第1部分： 醫(yī)療診斷超聲波場分類表 | IEC 61681-1: Ultrasonics - Field safety - Part 1: Classification scheme for medical diagnostic ultrasonic fields |
| prEN 61973-2000 | 超聲學(xué) 場特性 測定醫(yī)療診斷超聲場安全分類曝光參數(shù)的試驗方法 | IEC 61973: Ultrasonics - Field characterisation - Test methods for the determination of exposure parameters for the safety classification of medical diagnostic ultrasonic fields |
| prEN 62286-2001 | 消費電子產(chǎn)品和網(wǎng)絡(luò)的服務(wù)診斷接口 | Service diagnostic interface for consumer electronics products and networks |
| 編號 | 中文名稱 | 英文名稱 |