AAMI HE74
医疗器械人为因素设计流程
Human Factors Design Process for Medical Devices
AAMI SW68
医疗器械软件 – 软件使用周期流程
Medical Device Software - Software Life Cycle Processes
AAMI TIR12
卫生保健设施中需要重新处理的可重用医疗器械的设计、测试和标记：设备制造商指南
Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers
ANSI Z80.3
眼科学非处方太阳镜和时尚眼镜要求
Ophthalmics Nonprescription Sunglasses and Fashion Eyewear Requirements
ASTM 13.01
医疗和手术材料及仪器；麻醉和呼吸设备
Medical and Surgical Materials and Devices; Anesthetic and Respiratory Equipment
ASTM F 1980
消毒医疗器械加速老化标准指南
Standard Guide for Accelerated Aging of Sterile Medical Device Packages
BSI BS EN 1041
由制造商随同医疗器械一起提供的信息
Information Supplied by the Manufacturer with Medical Devices
BSI BS EN 60601-1-2
医疗电气设备 – 第 1-2 ：通用安全要求 – 并行标准：Electromagnetic Compatibility – Requirements and Tests 电磁兼容性 – 要求和测试 -IEC 60601-1-2: 2001
Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests-IEC 60601-1-2: 2001
BSI BS EN 980
医疗器械标签中使用的图形符号
Graphical Symbols for Use in the Labelling of Medical Devices
BSI BS EN ISO 14971
医疗器械 – 医疗器械风险管理应用
Medical Devices - Application of Risk Management to Medical Devices
EU 93/42/EEC
在部署与医疗器械有关的议会指令过程框架下，与委员会进行沟通， (1)-98/C 144/02；含与 EEA 有关的文字
Commission Communication in the Framework of the Implementation of Council Directive in Relation to Medical Devices (1)-98/C 144/02; Text with EEA Relevance
EU 98/79/EC
欧洲议会和欧洲委员会体外诊断医疗器械指令
Directive of the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
IEC 60601-1
医疗电气设备第 1 部分：通用安全要求
Medical Electrical Equipment Part 1: General Requirements for Safety
IEC 60601-1-1
医疗电气设备第 1-1 部分：通用安全要求 - 并行标准：医疗电气系统安全要求
Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems
ISO 11607
最终消毒的医疗器械包装
Packaging for terminally sterilized medical devices
ISO 13485
医疗器械质量管理系统法规要求
Medical devices Quality management systems Requirements for regulatory purposes
ISO 14971
医疗器械 ?C 医疗器械风险管理应用
Medical Devices - Application of Risk Management to Medical Devices
ISO 15223
用于医疗器械标签的医疗器械符号，提供标签标记和信息
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
ISO 17025
测试和校实验室能力通用要求 - 第一版；取消并取代“ISO/IEC Guide 25: 1990”
General Requirements for the Competence of Testing and Calibration Laboratories-First Edition; Cancels and Replaces ISO/IEC Guide 25: 1990
NEMA NU 1
闪烁照相机性能测量法
Performance Measurements of Scintillation Cameras
NEMA NU 2
定位放射断层摄影性能测量法 - 取代“NU 1:1994”
Performance Measurements of Position Emission Tomographs-Replaces NU 1:1994
NFPA 99
卫生保健设施标准
Standard for Health Care Facilities
UL 60601-1
医疗电气设备美国保险商试验所 (UL) 安全标准，第 1 部分：通用安全要求 - 取代“UL 2601-1”
UL Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety-Replaces UL 2601-1
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