Medical Equipment Testing & Certification

For more than 20 years, F2 Labs has been guiding customers through the electrical product testing and certification process for markets around the world. Our experience in electrical product testing enables us to provide testing and certification for a wide range of products and industries, such as medical equipment testing and certification.

Examples of Types of Medical Equipment We Test

  • Nebulizers
  • Infusion pumps
  • Pulse Oximeters
  • Wheelchairs
  • Autoclaves
  • Fetal Monitors
  • Blood chemistry analyzers
  • CPAP
  • Feeding pump
  • Infant incubator
  • Nerve Stimulator
  • Oxygen concentrator
  • Patient Scale
  • Surgical headlamp
  • Surgical table
  • Vital sign monitor
  • Medical Laser equipment
  • Defibrillators

Examples of Relevant Standards We Test & Certify To

  • IEC 60601-1 – 3rd edition – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2 – 4th edition – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
  • IEC 60601-1-11 – 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
  • IEC 60601-1-8 – Medical electrical equipment – Part 1-8: General requirements forbasic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
  • AIM 7351731 – Medical Electrical Equipment & System Electromagnetic Immunity Test for RFID Readers
  • IEEE C63.27 – American National Standard for Evaluation of Wireless Coexistence
  • ISO 7176-21:2009 – Wheelchairs – Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
  • ANSI/RESNA WC-2 2009, Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters
  • IEC 60601-2-22 – Part 2-22 – Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
  • IEC 60601-2-3 – Part 2-3 – Particular requirements for the basic safety and essential performance of short-wave therapy equipment
  • IEC 60601-2-4 – Part 2-4 – Particular requirements for the basic safety and essential performance of cardiac defibrillators
  • IEC 60601-2-37 – Part 2-37 – Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • IEC 80601-2-35 – Part 2-35 – Particular requirements for basic safety and essential performance of heating devices using blankets, pads, mattresses and intended for heating in medical use
  • IEC 60601-2-52 – Part 2-52 – Particular requirements for the basic safety and essential performance of medical beds
  • IEC 60601-2-57 – Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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F2 Labs
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Maryland - F2 Labs
26501 Ridge Rd
Damascus, MD 20872
301-253-4500
Ohio - F2 Labs
16740 Peters Rd
Middlefield, OH 44062
440-632-5541
Indiana - F2 Labs
8583 Zionsville Rd
Indianapolis, IN 46268
877-405-1580