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Electrical Safety Test Medical Equipment SPE-3000 Standard

    Home Electrical Safety Test Medical Equipment SPE-3000 Standard

    Medical Electrical Equipment Testing SPE-3000

    Take QAI’s expert advice to get your Medical Electrical Equipment tested and approved under the SPE-3000 code

    A vector of ultrasound specialist with ultrasonic equipment

    Special Inspection Service SPE-3000 was developed to address the need for an evaluation of electrical safety of Medical Equipment and Medical Electrical Systems. Equipment in compliance with the requirements and bearing the Special Inspection Service label is considered to be acceptable to the AHJ.

    Medical Equipment Tests under SPE-3000 includes such equipment as:

      • -Ultrasound diagnostic units
      • -Patient beds
      • -Operating tables
      • -Operation theater lights
    • For medical equipment safety tests not included in the SPE-3000 standard, please contact us and we can assist with the appropriate standards/testing that will apply.
    • QAI’s Electromagnetic Compatibility (EMC) lab is ISO 17025 accredited to complete EMC testing on medical products to IEC 60601-1-2. Let QAI’s experienced EMC staff test your medical device. See details here.

    Field Evaluations for Electrical Safety on Medical Equipment

    Field inspections and labeling of medical electrical equipment (MEE) and medical electrical systems (MES) brought into Canada in limited quantities or one-offs.

    SPE-3000 sets requirements for the construction, marking and testing for the field evaluation of both MEE and MES. This evaluation is to be conducted by a field evaluation body accredited by the SCC and/or recognized by the regulatory authority.

    The importance of this standard to the medical industry is enormous and allows manufacturers, distributors, hospitals, and medical clinics the ability to get their product approved efficiently at an affordable rate.

    Special Inspection Label Sample QAI

    QAI Laboratories is a Standards Council Of Canada (SCC) Inspection Body accredited to perform these approvals that is recognized by the Authorities Having Jurisdiction (AHJ’s) Across Canada.

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    Has your medical equipment already been shipped or installed without Certification or approval? Do you need an efficient turnaround time to get your product approved?

    Feel free to contact us: info@qai.org

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    Founded in 1994 by a group of experienced certification and testing experts, QAI is an independent third-party testing, inspection and certification organization which serves the building industry, government and individuals with cost effective solutions through our global, in-house capabilities / services.

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    • SERVICES
      • Core Services
        • Product Certification Services
        • Product Testing Services
        • Product Quality Inspection Services
        • Cost Advantage
        • Accreditations
      • Industry Focus
        • Electrical Safety
        • EMC EMI
        • Building Products Testing and Certification
        • Fenestration Testing and Certification
        • Plumbing Certification
        • Testing and certification of Gas Products
        • Certification of RVs and Park Model Trailers
        • Transport Canada
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        • Special Inspections on Electrical Devices
        • Electrical Safety Test Medical Equipment SPE-3000 Standard
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