Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Overview

Find information on the requirements for getting medical devices authorized in Canada on the medical devices page.

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About FFRs

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:

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. However, most recently, Canada developed its own standard requirements for FFRs, outlined in CSA Z94.4.1. This standard includes additional requirements for biocompatibility, breathability information, strap strength testing and general fit testing.

Certification and testing process

As part of Health Canada‚Äôs 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:

Health Canada is issuing IO authorizations during the pandemic for Canadian made respirators with the same expected level of safety and quality as NIOSH-certified respirators. These authorizations set out the:

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 breathe 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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