RF Wireless Coexistence - FDA 射频无线共存
根据FDA的质量体系法规21 CFR Part 820(FDA’s quality system regulation 21 CFR Part 820)，医疗器械制造商有义务管理无线设计（射频干扰，共存，多路径）相关的风险，这些风险被纳入医疗设备。为了根据 21 CFR 820.30（g）(21 CFR 820.30(g)) 验证无线医疗设备的设计，开发人员必须在设计验证中包括射频无线通信和控制功能的风险分析。医疗设备的功能和预期用途应与无线技术的功能和预期性能适当匹配。总之，上面列出的焦点应该是FDA风险管理和评估文件的一部分，并且需要提供这些要点的测试证据（包括无线共存和RF干扰）。此外，美国国家标准协会（ANSI）（工作组C63.27）已经制定了无线共存测试标准。FDA接受根据此ANSI C63.27标准进行的无线共存测试。
- 无线技术的选择和性能
- 无线服务质量 (QoS)
- 无线共存
- 无线信号和数据的安全
- 无线技术的 EMC（RF 干扰）
- 正确设置和操作的信息
- 维护注意事项
- Selection and performance of wireless technology
- Wireless Quality of Service (QoS)
- Wireless coexistence
- Security of wireless signals and data
- EMC of the wireless technology (RF interference)
- Information for proper set-up and operation
- Considerations for maintenance
FDA 认证无线共存设计
我们支持客户开发符合FDA标准的无线共存设计：
定义无线服务质量 （QoS）
并指出在哪些现实条件下需要满足此 QoS，即完整的需求规范。
识别特定风险
与功能相关并由无线通信控制或影响。这些是在早期设计阶段确定的。我们为客户提供支持，或者可以查看已经执行的分析。结合现实生活中的压力测试，例如：
这些测试将完成FDA要求的无线设计的风险管理，另外：
- 制定测试计划
- 并快速有效地执行这些测试，以及
- 执行现场勘测干扰测试，在医院等最终用户环境中。
FDA认可的无线医疗设备相关标准
以下是与射频无线医疗设备相关的几个公认标准。有关公认标准的更多信息，请访问 FDA 公认共识标准数据库。
- 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
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ANSI C63.27-2017.pdf
