NIOSH N95 designation for filtering facepiece respirators (FFR)

Jan 24, 2024

On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. They also make it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. Health Canada will be updating the content of this page soon. For more information, please refer to the notice on Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices and guidance on Medical devices for use in relation to COVID-19.

In Canada, most people are familiar with respirators designated as N95 by the US National Institute of Occupational Safety and Health (NIOSH). NIOSH is responsible for:

The NIOSH N95 respirator is one of those certified products. The term "N95" represents 2 aspects:

There are also "R" and "P" designations, which refer to "somewhat resistant to oil" and "strongly resistant to oil," respectively.

NIOSH-certified N95 respirators have been:

The COVID-19 pandemic increased the number of face coverings and respirators available on the Canadian market. The increase in manufacturers resulted in some manufacturers using the term "N95" in isolation or as a device name even though they are not NIOSH-certified, leading to confusion. Respirators that are marketed simply as "N95" have not been certified by NIOSH.

Health Canada requires that FFRs (for example, N95s and 95PFE or CA-N95):

If neither of the above are present, the product will be subject to compliance and enforcement actions. In the case of the N95, if the product is not NIOSH-certified then it must state that it is not NIOSH-approved. This statement must be either on the respirator and/or on its immediate packaging. Without this statement, the product may be considered misleading.

Health Canada expects that respirators that conform to NIOSH or similar standards will:

This labelling requirement is specified in section 21(1)(h) of the Medical Devices Regulations (MDR). It requires that performance specifications are included on a medical device label if it is necessary for the proper use of the medical device. Respirator performance specifications are inherent in respirator standards. Overall, respirator labelling is expected to comply with sections 21 to 23 of the MDR.

Canada now has its own national standard for FFRs, which was created during the COVID-19 pandemic (CSA Z94.4.1). Before creating this standard, Health Canada created safety and performance specification guidance during the pandemic to give Canadian manufacturers the option of creating a "Made in Canada" solution. The Canadian Standards Association (CSA) Group launched a certification program for respirators to the Health Canada guidance as an interim measure. This gave Canadian manufacturers an alternative certification to that of NIOSH, while still upholding similar standards of safety, effectiveness and quality. Now with the creation of the national CSA Z94.4.1 standard, CSA has begun certifying to this new standard.

Health Canada issues an interim order authorization when comparative NIOSH testing is confirmed by independent testing facilities. Testing through a Standards Council of Canada-accredited laboratory will also be accepted if manufacturers are certifying through the CSA Group. You can find further information on the regulatory considerations for FFRs in this notice.

To maintain NIOSH approval, respirators must:

The major specifications for NIOSH-certified N95 FFRs are listed on the Government of Canada's buyandsell website. Additional certification criteria and requirements include:

NIOSH filter series and filter efficiency level (for example, N95, N99, N100, R95, P95, P99, P100) appear on the respirator, but never without complete labelling. You can find a list of certified FFRs on the NIOSH website.

There are several international standards that are considered comparable to NIOSH N95 with respect to particle filtration efficiency (PFE). These standards require at least 94% PFE and their specifications are also outlined in the buy and sell website. These include standards from regions such as:

In the interim, while manufacturers transition to the certification program to CSA Z94.4.1, Health Canada will recognize manufacturers who conform to the Canadian respirator guidance specifications and a conformity assessment program. The conformity assessment requirements are designed to make sure manufacturers are committed to the ongoing quality and performance of their products. The specifications in Health Canada's guidance and in the CSA standard are based on NIOSH requirements for filtration and inhalation/exhalation performance, with some notable improvements. These improvements are outlined in our notice on the new CAN Z94.4.1 standard. They also include options for surgical respirators in compliance with U.S. Food and Drug Administration (FDA) fluid resistance and flammability requirements. Manufacturers are asked to label their filter efficiencies on respirators and packaging in addition to the level of fluid resistance for surgical respirators.

In addition to the FDA and/or NIOSH requirements, Health Canada's specifications request the following for all respirators for which manufacturers are applying for interim order authorization:

Health Canada also requires manufacturers to demonstrate stability testing and provide evidence of quality systems manufacturing procedures.

The new CSA standard has made additional improvements to the Health Canada specifications, such as:

Commercial FFRs must comply with GB2626-2006 non-powered air purifying particle filtering facepiece. The key elements include:

Medical (or surgical) grade FFR must comply with GB 19803-2010 protective face mask for medical use. The key elements include:

The labelling must include the:

For example, "Korea Filter (KF) 1st Class (≥94%)"

These respirators are classified by the filter efficiencies and inward leakage values.

Labelled filter efficiencies must appear on the packaging:

The packaging and/or respirator lists:

The labelling will contain the standard met and the filter efficiency P2 (≥94%).

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