FDA Recognized Standards
- ISO14117 (2012): Active implantable medical devices— Electromagnetic compatibility
- AAMI TIR18: Guidance on electromagnetic compatibility of medical devices in healthcare facilities (2010)
- ANSI/RESNA WC-2: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs (2008)
- IEC 60601-1-2:Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (2007)
- ANSI C63.18: ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radio frequency transmitters (1997)
IEEE 802.11 family of standards:
- IEEE 802.11: IEEE Standard for Information technology--Telecommunications and information exchange between systems Local and metropolitan area networks--Specific requirements Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications
- IEEE 802.11a: IEEE Standard for Telecommunications and Information Exchange Between Systems - LAN/MAN Specific Requirements - Part 11: Wireless Medium Access Control (MAC) and physical layer (PHY) specifications: High Speed Physical Layer in the 5 GHz band. This standard is an extension of 802.11 that applies to wireless LANs and provides up to 54 Mbps in the 5 GHz band .
- IEEE 802.11b: IEEE Standard for Information Technology - Telecommunications and information exchange between systems - Local and Metropolitan networks - Specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) specifications: Higher Speed Physical Layer (PHY) Extension in the 2.4 GHz band .
- IEEE 802.11g: IEEE Standard for Information technology-- Local and metropolitan area networks-- Specific requirements-- Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications: Further Higher Data Rate Extension in the 2.4 GHz Band .
- IEEE 802.11n: IEEE Standard for Information technology-- Local and metropolitan area networks-- Specific requirements-- Part 11: Wireless LAN Medium Access
Control (MAC)and Physical Layer (PHY) Specifications Amendment 5: Enhancements for Higher Throughput.
Industry Guidance and Guides
- Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff (2013)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (2013)
- Wireless Medical Telemetry Risks and Recommendations (2000) Deciding When To Submit A 510(k) For A Change To An Existing Wireless Telemetry Medical Device: Final Guidance for FDA Reviewers and Industry (2000)
- Electromagnetic Compatibility Aspects of Medical Device Quality Systems
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