Medical Devices Directive 93/42/EC Evaluation and Testing

Manufacturers must comply with the Medical Device Directive, MDD 93/42/EEC, in order to sell their medical products into Europe. F2 Labs can perform the EMC and Safety testing that is required by the Medical Device Directive for medical electrical products. With more than 20 years’ experience in navigating the CE/IEC Certification process, you can count on us to get you through the process of Medical Device Directive testing.

Electrical Product Compliance Testing

F2 Labs offers a full range of compliance testing services. We are fully equipped to test and approve a wide range of electrical products and equipment for organizational and governmental certifications, from battery chargers and lighting equipment to medical electrical equipment and wireless devices. Request a quote today!

Definition of Medical Device – Any instrument, apparatus, appliance, material or other article, intended by the manufacturer to be used for human being for the purpose of: diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.

Contact F2 Labs today for assistance with required MDD 93/42/EEC certification testing, and get your medical device successfully into the European market.

Common Collateral & Particular Standards*
  • EN 60601-1-6 – Part 1-6
    Medical electrical equipment – General requirements for basic safety and essential performance – Collateral standard: Usability
  • EN 60601-1-9 – Part 1-9
    Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design
  • EN 60601-1-11 – 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
  • EN 60601-2-22 – Part 2-22
    Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
  • EN 60601-2-3 – Part 2-3
    Particular requirements for the basic safety and essential performance of short-wave therapy equipment
  • EN 60601-2-4 – Part 2-4
    Particular requirements for the basic safety and essential performance of cardiac defibrillators
  • EN 60601-2-37 – Part 2-37
    Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • EN 60601-1-8 – Part 1
    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
  • EN 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
  • EN 60601-2-52 – Part 2-52
    Particular requirements for the basic safety and essential performance of medical beds
  • EN 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

* Please note: This is a partial list of collateral standards.

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