AAMI TIR 69: Association for the Advancement of Medical Instrumentation - Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems (2017)
ANSI C63.27/D1.0: American National Standards Institute - Standard for Evaluation of Wireless Coexistence (2017)
ISO 14117 (2012): Active implantable medical devices - Electromagnetic compatibility-EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
包含医疗设备的IT网络风险管理标准
IEC 80001-2-1 Edition 1.0 2012-07, Application of Risk Management for IT- Networks Incorporating Medical Devices - Part 2-1: Step-by-Step Risk Management of Medical IT-Networks - Practical Applications and Examples
AAMI/ANSI/IEC TIR 80001-2-1 2012, Application of Risk Management for IT-Networks Incorporating Medical Devices - Part 2-1: Step-by-Step Risk Management of Medical IT-Networks; Practical Applications and Examples
IEC TR 80001-2-2 Edition 1.0 2012-07, Application of Risk Management for IT Networks Incorporating Medical Devices - Part 2-2: Guidance for the Disclosure and Communication of Medical Device Security Needs, Risks and Controls
AAMI/ANSI/IEC TIR 80001-2-2:2012, Application of Risk Management for IT Networks Incorporating Medical Devices - Part 2-2: Guidance for the Disclosure and Communication of Medical Device Security Needs, Risks and Controls
IEC 80001-2-4 Edition 1.0 2012-11, Application of Risk Management for IT-Networks Incorporating Medical Devices -- Part 2-4: Application Guidance - General Implementation Guidance for Healthcare Delivery Organization
AAMI/ANSI/IEC TIR 80001-2-4:2012, Application of Risk Management for IT-Networks Incorporating Medical Devices -- Part 2-4: General Implementation Guidance for Healthcare Delivery Organization
IEC TR 80001-2-5 2014, Application of Risk Management for IT-Networks Incorporating Medical Devices - Part 2-5: Application Guidance - Guidance on Distributed Alarm Systems
AAMI /ISO / TIR 80001-2-6: 2014, Application of Risk Management for IT Networks Incorporating Medical Devices – Part 2-6: Application Guidance – Guidance for Responsibility Agreements
此外,还有与无线医疗设备相关的电磁兼容性(EMC)标准
IEC 60601-1-2 Edition 3: 2007: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-2 Edition 4.0:2014: Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
AAMI/ANSI/IEC 60601-1-2: 2007/(R)2012: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
AAMI/ANSI/IEC 60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
AAMI TIR18: Association for the Advancement of Medical Instrumentation – Guidance on electromagnetic compatibility of medical devices in healthcare facilitiesExternal Link Disclaimer (2010)
ANSI/IEEE C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
AIM Standard 7351731, Medical Electrical Equipment And System Electromagnetic Immunity Test For Exposure To Radio Frequency Identification Readers - An Aim Standard
无线共存是产品在其用户环境中根据预定义的验收标准运行的能力,而其他无线通信系统同时运行。两个或多个相同类型的无线通信系统(例如Wi-Fi)之间的无线共存也称为互操作性。ANSI C 63.27标准描述了测试无线共存的方法,我们提供这些共存测试。共存也是FDA对无线医疗产品定义的风险方面。除了共存测试,我们还提供射频干扰测试,以研究无线设计的稳健性。