Related Product Support
N95, N99 and N100 respirators are FFRs tested by the U.S. National Institute for Occupational Safety and Health (NIOSH). FFRs were developed mainly to filter out airborne particulates of a certain size and for use in an industrial setting. Of these 3 respirators, N95 respirators in particular have been adopted for use in health care settings, as protection against influenza and other infectious particles (for example, M. tuberculosis). Both WHO’s interim guidance and a toolkit by the U.S. Occupational Safety and Health Administration (OSHA) suggest they can be used as a component of personal protective equipment (PPE) for use during the COVID-19 pandemic to reduce the spread of infection.
Canada’s national standard, CAN/CSA-Z94.4-18, outlines the selection, use and care of respirators. This standard is based partially on NIOSH testing and quality requirements. Given the familiarity and trust in NIOSH-certified respirators, many employers use NIOSH-certified respirators in the selection of their FFRs. During the COVID-19 pandemic, there is a high demand for NIOSH-certified N95 respirators and consequently, a very low supply. NIOSH also recently announced suspension of new applications for N95 certification by manufacturers outside the U.S.
As a result, the Government of Canada has been working with external stakeholders to increase the domestic production of FFRs. However, the level of confidence in respirators not certified by NIOSH is low, and consequently respirators meeting equivalent standards are largely not sought or found acceptable. As well, Health Canada and our program partners, such as the Public Health Agency of Canada (PHAC) and National Research Council (NRC) supported by research and foundational work by the CSA Group, have collaborated to develop this guidance to fill a gap for Canadian manufacturers seeking to create alternative solutions to N95 respirators in Canada. PHAC and NRC have contributed to the development of testing of N95 and equivalent respirators during the COVID-19 pandemic.
The guidance for FFRs is in effect until the IO expires on March 18, 2021, or until a robust and Standards Council of Canada (SCC) accredited certification scheme is developed. The use of this guidance by Canadian manufacturers, and the designation of a “PFE” particulate filter efficiency level as opposed to “N” particulate filter efficiency level, has been proposed, as these respirators will not be certified by NIOSH but tested in Canadian labs (including at NRC, CSA or other SCC-accredited labs).
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