EMC Compliance Requirements on Medical Devices

ISO/IEC 60601-1-2:2014 EMC Medical, 4th Edition (covers emissions and immunity)

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.

AIM 7351731 RFID Exposure Immunity

Medical Electrical Equipment and Systems: Electromagnetic Immunity Tests for RFID Readers

ISO/IEC 60601-1-11:2015 Medical Compliance Home Health Care Items

Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

ISO/IEC 60601-1-12:2014 Medical Electrical Equipment

Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment

ISO/IEC 60601-2-10 Ed. 2.1 b:2016 Nerve and Muscle Stimulators

Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

ISO/IEC 60601-1-6:2010 Usability

Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

ISO/IEC 60601-1-8:2006 Alarms

Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Please call us today to see how D.L.S. can help you make your medical device compliant.