Certifications

ISO 9001:2015

The Orthopaedic Innovation Centre operates a Quality Management System which complies with the requirements of ISO 9001:2015 for Biomedical engineering, medical device consulting services, product testing, validation, and contract research.

ISO/IC 17025:2017

Accreditation to ISO/IEC 17025:2017, granted by the Standards Council of Canada, signifies that OIC has both the technical, managerial, and quality systems in place to ensure accuracy and impartiality, and that processes related to sampling, testing, analysis, and reporting are consistent and monitored. Clients seeking these services will be able to engage with the OIC and enable future expansion and breakthrough into new markets for PPE testing and other medical devices.

The scope of accreditation as listed by the Standards Council of Canada at https://www.scc.ca/en/accreditation/laboratories/orthopaedic-innovation-centre includes:

  • CAN/CSA-Z94.4 Selection, use and care of respirators
  • CAN/CSA-Z94.4.1:21 Performance of filtering respirators
  • ASTM F2100 Performance of materials used in medical face masks
  • ASTM F2299 Test method for particulate filtration efficiency (PFE)
  • ASTM F2101 Test method of bacterial filtration efficiency (BFE)
  • ASTM F1862 Test method for synthetic blood penetration
  • EN 14683:2019 Test method for breathability of medical face masks
  • 16 CFR Part 1610 Test method for flammability of clothing textiles
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