New CSA Group standard for filtering respirators: Notice

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

On this page

• Background
• New national respirator standard and certification program
• Health Canada supports and recognizes the new CSA standard
• Impact on already authorized respirators
• Additional guidance for manufacturers with an IO-authorized FFR
• Differences between our guidance and CSA Z94.4.1 standard

Background

On August 25, 2020, Health Canada published the Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19. The guidance established a common set of Canadian interim order (IO) requirements during the pandemic. At the time, a national standard for FFRs did not exist.

This guidance was an interim measure until a national FFR standard and complementary certification process would be developed.

New national respirator standard and certification program

On October 29, 2021, the Canadian Standards Association (CSA) Group published CSA Z94.4.1:21 Performance of filtering respirators, followed by the French version on December 17, 2021. CSA Group launched its certification program to this new standard on December 3, 2021.

The Canadian standard and accredited certification program provide manufacturers with an equivalent option to the U.S. NIOSH certification program for filtering respirators.

The new Canadian standard includes:

• equivalent performance testing and quality requirements offered in the NIOSH 42 Code of Federal Regulations 84 standards
• other requirements and enhancements (described in detail below)

It also covers other filtering respirators, such as full facepiece respirators and powered air-purifying respirators, which are not covered in Health Canada's FFR guidance.

Health Canada supports and recognizes the new CSA standard

For ongoing applications, Health Canada will continue to recognize either:

• the existing guidance for the safety and performance of FFRs and/or
• previously received certification to this guidance by a Standards Council of Canada (SCC)-accredited certification body (such as the CSA Group)

For new applications, Health Canada encourages, supports and recognizes the acceptance and conformity to the new CSA Z94.4.1 standard.

Impact on already authorized respirators

Authorized and certified under the IO guidance

There is no change to respirators already authorized under the IO that have tested to Health Canada's respirator guidance. Manufacturers can continue to sell their IO-authorized respirators certified to this guidance.

Authorized under the IO with a certification by CSA Group to the IO guidance

Manufacturers with an IO authorization for an FFR may continue to sell your products under your certification to the IO respirator guidance. However, your current certification with CSA Group will expire by December 1, 2022.

You should consult the CSA Group website for guidance on how to update your certification to the new standard should you wish to do so. The CSA Group is giving manufacturers a grace period to move over to the new standard for respirators already certified to the IO guidance on FFRs. You have until June 1, 2022, to notify CSA you have started the process to convert to the new certification program.

To date, only the CSA Group has created a certification program to the Health Canada IO Guidance on FFRs. However, now that the new CSA Z94.4.1 standard has been published, the SCC may accredit other certification bodies to this Canadian standard. Please refer to SCC's website for the list of accredited bodies to the CSA Z94.4.1 standard.

Additional guidance for manufacturers with an IO-authorized FFR

Manufacturers with an IO and certified to Health Canada's guidance on FFRs

Manufacturers are encouraged to contact the CSA Group to certify to the new standard. Once the new certification is received, you may voluntarily submit confirmation of your new certification to the CSA Z94.4.1 standard to Health Canada.

Manufacturers with an IO with outstanding conditions pertaining to certification

Manufacturers choosing to pursue Canadian certification should pursue certification to the new CSA Z94.4.1 standard requirements as opposed to the requirements outlined in Health Canada's guidance on FFRs. You may submit your certification confirmation information from an SCC certified body to Health Canada along with an IO amendment application.

Health Canada encourages you to submit amendment applications during the IO period in order to remove existing conditions.

Differences between our guidance and CSA Z94.4.1 standard

A high-level summary of the differences between Health Canada's respirator guidance and the new CSA Z94.4.1 standard are outlined in the following table.

The above is only a general summary.

Please consult CAN Z94.4.1 for details on the requirements to this new standard. You are advised to consult your certification body to update or obtain certification to this standard.

Related links

• Regulatory considerations on the classification of respirators
• Regulatory considerations on the classification of non-medical masks or face coverings
• Importing and exporting medical devices
• Important safety information for certain respirator masks
• About non-medical masks and face coverings
• Guidance on safety and performance of filtering facepiece respirators (FFRs) during COVID-19 (airflow resistance testing)