Shortages of personal protective equipment (PPE) in the early months of the COVID-19 pandemic highlighted the need for a domestic supply of filtering respirators in Canada that meet required performance and quality requirements to protect Canadians. In response to this need, CSA Group, with support from the Standards Council of Canada (SCC), published a new standard that specifies performance and testing requirements for filtering type respirators.
CSA Z94.4.1:21 Performance of Filtering Respirators incorporates quantitative fit testing, shelf life, comfort and breathability requirements. This new National Standard of Canada is intended to support the implementation of a Canadian certification program, eventually replacing the Health Canada Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) issued during COVID-19 in 2020. Early guidance was intended to provide immediate resolution to critical product approval and supply issues. The Guidance provides classification of respirator types and performance criteria to allow certification of respirators following requirements approved by the United States National Institute for Occupational Safety and Health (NIOSH) with some additional requirements.
Given the trust and familiarity that Canadian regulators, suppliers and user communities have with NIOSH, an objective of CSA Z94.4.1:21 is to align with NIOSH requirements, while addressing some of the specific needs and requirements identified during COVID-19. Some of the key additions include:
- Fit testing: A quantitative fit test requirement is included, with emphasis on serving the needs of the user population and includes an ergonomic and comfort assessment.
- Air flow resistance and breathability: Additional classes with lower airflow resistance have been introduced as options to address breathability and Fluid and flammability resistance: Fluid and flammability resistance has been added to address medical and surgical use applications.
- Shelf life: Requirement included for manufacturers to provide validation of the chosen lifetime.
The first edition of CSA Z94.4.1:21 covers filtering respirators for particulate matter only, addressing the priority need resulting from COVID-19, most notably the needs of Canadian health care and essential workers.
“Building a strong and self-sufficient PPE product ecosystem will depend on how successfully we can develop and implement a Canadian certification and testing program,” says David Weinstein, President & CEO, CSA Group. “CSA Z94.4.1:21 is a made-in-Canada standard that builds on the strength of NIOSH requirements, while addressing the specific needs of our frontline workers brought to life during the pandemic. We’re optimistic that local jurisdictions across Canada will recognize this need and consider adopting the new National Standard by reference into legislation.”
To develop the new National Standard, CSA Group worked collaboratively with key stakeholders, including government, academia, end-users, and respirator manufacturers.
“The pandemic underscored standardization’s role in protecting the agility of our health care system,” says Chantal Guay, CEO of SCC. “This new standard strengthens Canada’s domestic capability to remain flexible to pressing and future equipment needs of frontline workers.”
CSA Z94.4.1:21 is available in English and French.
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About CSA Group
CSA Group is a global organization dedicated to safety, social good and sustainability. We are a leader in Standards Development and in Testing, Inspection and Certification around the world including Canada, the U.S., Europe and Asia. Our mandate is to hold the future to a higher standard.
About the Standards Council of Canada
Established in 1970 as a federal Crown corporation, the Standards Council of Canada (SCC) is Canada’s voice on standards and accreditation on the national and international stage. SCC works closely with a vast network of partners to promote the development of effective and efficient standards that protect the health, safety and well-being of Canadians while helping businesses prosper. As Canada’s leading accreditation organization, SCC creates market confidence at home and abroad by ensuring that conformity assessment bodies meet the highest national and international standards. SCC advances Canada’s interest on the international scene as a member of the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) by connecting thousands of people to global networks and resources, opening a world of possibilities for Canadians and businesses.