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Medical Device 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

3rd edition – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

4th edition – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

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

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

Medical Electrical Equipment & System Electromagnetic Immunity Test for RFID Readers

American National Standard for Evaluation of Wireless Coexistence

Wheelchairs – Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters

Part 2-22 – Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment

Part 2-3 – Particular requirements for the basic safety and essential performance of short-wave therapy equipment

Part 2-4 – Particular requirements for the basic safety and essential performance of cardiac defibrillators

Part 2-37 – Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

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

Part 2-52 – Particular requirements for the basic safety and essential performance of medical beds

Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use