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

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.

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.