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Electromagnetic Compatibility & Wireless Medical Devices
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FDA > CDRH > Electromagnetic Compatibility & Wireless Medical Devices > Recognized Standards

Recognized Standards

  • IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)). 
     
  • AAMI / ANSI / IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. 
     
  • ANSI / RESNA WC/Vol. 2-1998, Section 21, Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters. 
     
  • ANSI C63:19:2001, Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids

Updated January 24, 2006

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