CSA Group Launches First Lab in Canada to Offer a Range of Certification and Testing for Medical-Grade Personal Protective Equipment (PPE)
New dedicated lab will provide testing and certification services to manufacturers selling PPE in Canada
Currently, there is no industry standard to regulate the safety and performance of medical-grade PPE provided to healthcare professionals or made available to the public in Canada. Until recently, there has been no domestic provider of comprehensive testing and certification for medical grade masks, gloves and gowns. This lack of Canadian standards and comprehensive testing and certification creates a health and safety risk affecting all Canadians – which has become particularly apparent during the COVID-19 pandemic.
To address these issues, CSA Group has opened an accredited, special-purpose laboratory, dedicated to testing and certifying medical-grade PPE to meet applicable standards. The testing and certification services offered at the Toronto-based laboratory may help provide sufficient evidence required for manufacturers importing medical PPE into Canada to get authorization through the current Health Canada Interim Order (IO).
The Demand for PPE in a Pandemic
Canadian manufacturers and distributors of medical PPE know well the unprecedented demand for products that this global pandemic has created, and the scenarios that have played out as a result. Clients in the healthcare sector have desperately sought to keep their frontline staff and patients protected and safe. Manufacturers of non-medical products hurriedly retrofitted their assembly lines to help fill the supply shortages. Importers and distributors sourced product from multiple vendors in multiple jurisdictions, with no assurance of product safety.
Complicating this already difficult set of circumstances, NIOSH – the (U.S.) National Institute for Occupational Safety and Health – the division of the U.S. government responsible for testing and certifying “N95” and other filtering facepiece respirators (FFRs), stopped accepting new applications for N95 certification from manufacturers outside the U.S.
Three PPE imperatives
Three imperatives emerged from this unique set of circumstances:
- That an adequate supply of medical-grade PPE be available to meet the needs of Canadian healthcare workers, people with compromised immune systems and other at-risk individuals;
- That a significant portion of that supply be sourced domestically; and
- That standards for PPE quality be set and a methodology by which to test and certify PPE be established.
CSA Group’s new, pioneering role in testing and certifying PPE for the Canadian market will contribute to and/or facilitate each of these imperatives.
Testing & Certification: Products, Standards and Test Types
Five types of medical personal protective equipment are sold in the Canadian market:
- Medical masks
- Medical gloves
- Face shields
- Medical gowns/drapes
CSA Group offers testing and certification services for all major medical PPE according to CSA, ASTM, AAMI and CFR standards, as shown in the charts below.
Health Canada mandates that all personal protective equipment sold in Canada must be tested. When manufacturers test medical PPE products with CSA Group, they receive a report indicating that the medical PPE has been tested according to the standards indicated below. This report may be used to get authorization for the selling of the medical PPE in Canada through the Interim Order.
Testing and Certification by PPE Type
|Medical PPE Type||Material Type||Standard||Test Type|
Freedom from holes
Aqueous extractable protein
|Medical Gowns/Drapes||AAMI PB70||Barrier performance level (Levels 11 to 4)|
|Medical Mask||ASTM F2100||Bacterial filtration efficiency
Particulate filtration efficiency
|42 CFR Part 84||Filtration efficiency
|Face Shields||CSA Z94.3
|Performance requirements of face protectors against occupational hazards|
Certification: A Rigorous Process
The CSA Group testing and certification program, the first of its kind in Canada for a range of medical PPE products, entails a rigorous process to help ensure that the manufacturers of medical PPE meet the safety and operating performance standards required for the Canadian market. The process requires:
- Testing the PPE to help ensure that it meets the safety, performance and efficiency levels according to the applicable standards;
- Manufacturer factory audits with in-process quality checks and quarterly inspections of the facility that help ensure that all quality processes are in place;
- On-going conformity tests once a year to help ensure that the medical PPE production meets requirements; and
- Periodic audits of CSA Group to maintain their accreditation as a certification body.
Certification: The Benefits
As mentioned above, testing is mandatory for all PPE sold in the Canadian market. But having PPE certified confers benefits that manufacturers and distributors may want to consider.
- CSA Group certified PPE may bear the CSA mark of certification – an instantly recognizable emblem in Canada.
- The mark helps indicate to users that the PPE has undergone an independent certification program.
- The certification mark may also help with the procurement process, as customers may know at a glance that the product has been verified to a certain standard. This may help give manufacturers and distributors of certified PPE a competitive edge over those whose PPE has been tested but not certified.
- Access to historical test data that may be valuable in the event of a recall.
Certifying one’s PPE may also give a manufacturer a head-start on a future when the government may require that all PPE be certified.
CSA Group: Trusted, Respected, Internationally Recognized
In 1948, CSA Group (as the Canadian Standards Association) developed the first standards for personal protective equipment in Canada. More than 70 years later, CSA Group is leading the industry again, by being the first organization in Canada accredited to certify PPE and the first to operate a dedicated lab to test and certify PPE. It is a subsidiary of one of the most respected standards bodies in Canada and it is ready to meet your PPE testing and certification needs.
To learn more about CSA Group’s testing and certification services for PPE products, visit: csagroup.org/testing-certification/product-areas/personal-protective-equipment-ppe/medical-personal-protection-equipment
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