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/IEC 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 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2101 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- EN 14683:2019 Medical face masks – Requirements and test methods (Only For: Annex C)
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
