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:
Medical Devices
- ISO 14243-1
- Implants for surgery – Wear of total knee-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
- ISO 14243-2
- Implants for surgery – Wear of total knee-joint prostheses – Part 2: Methods of measurement
- ISO 14243-3
- Implants for surgery – Wear of total knee-joint prostheses – Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
- ASTM F2003
- Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
- ASTM F1877*
- Standard Practice for Characterization of Particles
- ISO 14242-1
- Implants for surgery – Wear of total hip-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
- ISO 14242-2
- Implants for surgery – Wear of total hip-joint prostheses – Part 2: Methods of measurement
- ISO 22622
- Implants for surgery – Wear of total ankle-joint prostheses – Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
- ASTM F2077
- Standard Test Methods for Intervertebral Body Fusion Devices
- ASTM F543
- Standard Specification and Test Methods for Metallic Medical Bone Screws
Personal Protective Equipment
- CAN/CSA-Z94.4*
- Selection, use and care of respirators (Only for: the Quantitative Fit Test (Annex C and CSA Z94.4.1-21 Section 5.6)
- CAN/CSA-Z94.4.1:21*
- Performance of filtering respirators
(Except for: oil-resistant CA-R (6.2.1.1.b) and oil-proof CA-P (6.2.1.1.c) type filter testing in non-powered air purifying respirators and all filter types of powered air-purifying respirators (7.2))
- Performance of filtering respirators
- ASTM F2100*
- Standard Specification for Performance of Materials Used in Medical Face Masks
(Except for: clause 6.3)
- 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)
- ASTM F3502*
- Standard Specification for Barrier Face Coverings
- 16 CFR Part 1610*
- Standard for the Flammability of Clothing Textiles (Except for: refurbishing (1610.6.b) including dry cleaning (1610.6.b.i) and laundering (1610.6.b.ii))
*Tests performed at 002 – 1095 Concordia Avenue, Winnipeg, Manitoba R2K 3S8