Canadian-based biomedical device testing company achieves laboratory accreditation to international standard ISO/IEC 17025
WINNIPEG, April 14, 2022 /PRNewswire-PRWeb/ -- The Orthopaedic Innovation Centre Inc. ("OIC" or "the Company), a non-profit centre for medical device testing, research, and development, announced today their accreditation to International Standards Organization (ISO) 17025:2017 which covers "general requirements for the competence of testing and calibration laboratories" for performance evaluation of personal protective equipment (PPE).
In response to the COVID-19 pandemic, manufacturing firms across the world pivoted their expertise to meet the need of the public by producing essential PPE products domestically. For manufacturers to maintain the safety of the public, they must adhere to the requirements and regulations that govern PPE usage. In order to do this, manufacturers require access to accredited PPE testing and evaluation laboratories for approval in healthcare and public use.
In September 2020, the OIC received funding from Western Economic Diversification Canada and the Province of Manitoba to establish a PPE testing laboratory to support Canadian PPE manufacturers. As the final milestone in this project, the OIC pursued and received accreditation to ISO/IEC 17025:2017, a significant advancement for OIC as a medical device specialist.
Accreditation to ISO/IEC 17025:2017, granted by the Standards Council of Canada, signifies that the laboratory 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
"Achieving this accreditation shows the determination of our team towards building a top-tier laboratory that supports and bolsters medical device manufacturers and innovators." said Trevor Gascoyne, Chief Executive Officer, Orthopaedic Innovation Centre. "For us, this is the first step in an ambitious multi-year initiative to grow our expertise and capabilities across multiple medical specialties and be a leading North American testing and development laboratory. We look forward to continued growth and success as we begin to tackle new challenges facing the healthcare ecosystem."
For more information on respirator, medical mask, and filter media testing or other medical device evaluations, please contact OIC via email at: [email protected] or visit OIC online at: https://www.orthoinno.com
About the Orthopaedic Innovation Centre
Backed by engineering expertise, experience, and a passion for research and innovation, the Orthopaedic Innovation Centre excels in supporting the medical device industry through product performance testing, precision measurement, clinical research services, and product development activities. OIC is ISO/IEC 17025:2017 accredited and has experience performing validation services for personal protective devices and orthopaedic implants, as well as providing mechanical and materials testing, precision measurement, and clinical services.
Media Contact
Graeme Findlay, Orthopaedic Innovation Centre, 1 204 803 7929, [email protected]
SOURCE Orthopaedic Innovation Centre
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