| 编号 | 中文名称 | 英文名称 |
|---|---|---|
| EN 12286-1998+A1-2000 | 体外诊断医疗器械 生物起源样品中数量的测量 标准测量程序表达 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures |
| EN 12287-1999 | 体外诊断医疗器械 生物起源样品中数量的测量 标准物质描述 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials |
| EN 12306-1997 | 生物技术 农业、植物和动物病虫害控制和环境污染中使用的诊断盒质量控制指南 | 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 | 体外诊断医疗器械 微生物学用培养基 培养基的性能标准 | In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
| EN 12376-1999 | 体外诊断医疗器械 由制造商提供的有关生物学染色用体外诊断剂的信息 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| EN 13532-2002 | 自检用体外诊断医疗设备的一般要求 | General requirements for in vitro diagnostic medical devices for self-testing |
| EN 13612-2002+AC-2002 | 体外诊断医疗设备性能评估 | Performance evaluation of in vitro diagnostic medical devices |
| EN 13640-2002 | 体外诊断剂的稳定性试验 | Stability testing of in vitro diagnostic reagents |
| EN 13641-2002 | 消除或减少与体外诊断剂相关的传染风险 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
| EN 13975-2003 | 体外诊断用医疗设备验收试验的取样方法 统计法 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
| EN 1658-1996 | 试管诊断仪器的标度要求 | Requirements for marking of in vitro diagnostic instruments |
| EN 1659-1996 | 试管诊断系统 微生物的培养基 术语和定义 | In vitro diagnostic systems - Culture media for microbiology - Terms and definitions |
| EN 375-2001 | 制造商提供的专业用试管诊断试剂信息 | Information supplied by the manufacturer with in vitro diagnostic reagents for professional use |
| EN 376-2002 | 制造商提供的自测试用试管诊断试剂信息 | Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing |
| EN 591-2001 | 专业人员用试管诊断仪器使用说明书 | Instructions for use for in vitro diagnostic instruments for professional use |
| EN 592-2002 | 自测试用试管诊断仪器使用说明书 | Instructions for use for in vitro diagnostic instruments for self-testing |
| EN 60336-1995 | 医用诊断装置X射线管组件 聚焦特性 | X-ray tube assemblies for medical diagnosis - Characteristics of focal spots (IEC 60336:1993) |
| EN 60406-1997 | 医用诊断X射线暗盒 X射线摄影盒与乳腺摄影暗盒 | Cassettes for medical X-ray diagnosis - Radiographic cassettes and mammographic cassettes (IEC 60406:1997) |
| EN 60601-1-3-1994 | 医用电气设备 第1部分：安全通用要求 并列标准 X射线诊断设备的辐射防护的一般要求 | 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 | 医疗电气设备 第2－22部分：诊断和治疗用激光设备安全的特殊要求 | 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 | 医用电气设备 第2－28部分：医疗诊断用X射线源组件和X射线管组件规范 | 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 | 医疗电气设备 第2－33：部分：医疗诊断用磁共振设备安全专用规范 | 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 | 医疗电气设备 第2－37部分：超声医疗诊断和监护设备安全的特殊要求 | 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 | 医疗电气设备 第2－41部分：外科手术灯和诊断用灯光的安全专用要求 | 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 | 医疗电气设备 第2－7部分：诊断X射线发生装置的高压发生器安全专用要求 | 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 | 医用诊断旋转阳极Ｘ射线管的电、热和负载特性 | Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis |
| EN 60627-2001 | 诊断用Ｘ－射线 成像设备 通用和大图形防散射滤栅的特征 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001) |
| EN 61010-2-101-2002 | 测量、控制和实验室用电气设备的安全要求 第2-101部分：生物体外诊断(IVD)医疗设备的特殊要求 | 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 | 对医疗超声波诊断设备声输出的要求 | Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:1992) |
| EN 61267-1994 | 医用诊断X射线设备 测定特性用辐射条件 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics (IEC 61267:1994) |
| EN 61331-1-2002 | 医用诊断X射线辐射防护器具 第1部分：材料衰减性能的测定 | Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials (IEC 61331-1:1994) |
| EN 61331-2-2002 | 医用诊断X射线辐射防护器具 第2部分：防护玻璃板 | Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates (IEC 61331-2:1994) |
| EN 61331-3-1999 | 医用诊断X射线辐射防护器具 第3部分：防护服和性腺防护器具 | 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 | 医用电气设备 用于X射线诊断成像中带电离室和/或半导体探测器的剂量仪 | 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 | 医疗电气设备 用于诊断放射线学中X射线管电压非发病测量的剂量测定仪 | 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射线图像诊断设备 乳腺摄影防散性滤线栅特性 | Diagnostic X-ray imaging equipment - Characteristics of mammographic anti-scatter grids (IEC 61953:1997) |
| EN 829-1996 | 玻璃试管内的诊断系统 医学和生物试样的传送包装 要求、试验 | In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements, tests |
| EN 928-1995 | 玻璃试管诊断系统 关于玻璃试管诊断医疗设备的EN 29001、EN 46001、EN 29002、EN 46002的应用指南 | 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 | 体外诊断检查系统 控制糖尿病自查用血糖监控系统的要求 | 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 | 体外诊断医疗装置 生物样品的定量测量 已知校正器及控制材料值的计量跟踪性 | 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 | 体外诊断医疗装置 生物样品的定量测量 用已知校准器和控制材料确定酶中催化剂浓度值的计量可跟踪性 | 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 | 医疗诊断用最大旋转阳极X射线管对称辐射场的测定 | Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis |
| prEN 14254-2001 | 体外诊断医疗设备 除血液外从人体采集的样品一次性贮存容器 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| prEN 61681-1-2000 | 超声学 场安全 第1部分： 医疗诊断超声波场分类表 | IEC 61681-1: Ultrasonics - Field safety - Part 1: Classification scheme for medical diagnostic ultrasonic fields |
| prEN 61973-2000 | 超声学 场特性 测定医疗诊断超声场安全分类曝光参数的试验方法 | 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 | 消费电子产品和网络的服务诊断接口 | Service diagnostic interface for consumer electronics products and networks |
| 编号 | 中文名称 | 英文名称 |