Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Overview
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The facepiece of an FFR is made of material that can filter both larger- and smaller-sized aerosol particles due to their inherent properties. There are several styles of FFRs. The 2 most common are the cup and flat fold styles.
Elastomeric respirators are made of a molded facepiece to which a replaceable filtering cartridge or filter is attached. Elastomeric reusable FFRs may have exhalation valves incorporated into their design to help with breathability and comfort.
Any FFR or elastomeric respirator with an exhalation valve should not be used in a setting where:
- environmental protection from the wearer is required or
- unfiltered air from the user may contaminate the environment (for example, a surgical field)
For these reasons, respirators with exhalation valves are not considered acceptable for use during a pandemic.
FFRs are designed to protect the user from inhaling particulate matter, including infectious particles. In Canada, the most frequently purchased respirators are certified by NIOSH and meet standards outlined by 42 CFR 84 in the U.S. Code of Federal Regulations.
As part of the interim order (IO) process, Canadian manufacturers must follow a common set of requirements. These include labelling requirements for the filtration efficiency rating. Manufacturers are encouraged to label their product in accordance with the marking scheme outlined in Table 3 on the FFR performance criteria page.
Certification and testing process
The NIOSH certification process is well established and includes a built-in framework. This framework helps to ensure that the respirators it certifies continue to meet quality and testing requirements post-certification. Information on this process can be found on the NIOSH website.
As part of Health Canada’s IO authorization process, manufacturers must receive certification that quality and performance is achieved and maintained. To help manufacturers meet this goal, the CSA Group has created a national certification process. For information on this newly established certification process, please contact the CSA Group Client Services Centre.
Similar to the NIOSH program, CSA certification includes an ongoing assessment of quality and conformity assessment. Highlights of requirements include the following:
- initial inspections of new and existing facilities new to manufacturing PPE before a product receives a CSA Mark to:
- evaluate the capability of the new factory to produce products using a consistent manufacturing process
- establish that the factory is aware of the conditions for applying a CSA Mark to products
- evaluate, where applicable, the ability of the new factory to produce certified products under a quality assurance/control system or with specialized equipment, material or processes
- unannounced quarterly factory inspections to verify that CSA-certified products continue to conform to their original certification requirements involve:
- certified product design, materials and manufacturing process
- required marking requirements, production line testing and sample selection for conducting conformity testing in the CSA lab
- conformity testing to ensure continued compliance of certified/accepted components/products with critical requirements, when visual inspection at the factory is inadequate
- periodic surveillance of marketed products by the CSA Group to ensure they comply with certification requirements and to spot counterfeit products or those that are misusing the CSA Mark
While NIOSH continues to prioritize U.S.-based manufacturing, Health Canada is issuing conditional IO authorizations during the pandemic. We’re doing this to provide Canadian oversight for new manufacturers of FFRs in Canada. These authorizations set out the:
- post-IO requirements for a quality plan assessment
- post-IO requirements for quality systems assessments
- ongoing quality control and in-line testing
FFRs provide a minimum 95% filtration protection for the wearer against small aerosol particles. The results of the NIOSH particulate filter efficiency test must meet or exceed 95% filtration of the aerosol particles. They must also confirm that the user can breather through the mask.FFRs need to pass additional standards to qualify as a surgical FFR, including flammability and fluid resistance tests.
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