NIOSH N95 designation for filtering facepiece respirators (FFR)

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• NIOSH N95 respirators and similar respirator types in Canada
• NIOSH certification
• Canadian respirators
• Canadian and international standards comparable to NIOSH

NIOSH N95 respirators and similar respirator types in Canada

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:

• setting standards in the US related to occupational safety and health
• the certification of products against those standards, which come from 42CFR84 of US legislation

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

• "N" indicates that the respirator is not resistant to oil
• "95" refers to the FFR's filtration efficiency where at least 95% of particles are filtered

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:

• sold in Canada for many years
• used in Canada predominantly due to their recognized quality

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):

• are labelled with the performance standard with the corresponding designation (for example, CA-N95 or 95PFE, N95 or KN95) and
• meet all aspects of the performance standard, including labelling

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:

• be labelled in accordance with their respective requirements
• not use terminology or naming conventions associated with other standards

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.

Canadian respirators

Canada had no national standard for FFRs before the COVID-19 pandemic. However, during the pandemic, a national standard was developed under the leadership of the CSA Group. Canada's national standard for FFRs was published on October 29, 2021, in English and on December 17, 2021, in French. The CSA Group launched its certification program to the new standard on December 3, 2021. In the interim, Health Canada created the safety and performance specification guidance during the pandemic for Canadian manufacturers who are providing a "Made in Canada" solution and without any existing certification to a respirator standard (e.g. outside of Canada). The guidance includes the same technical specifications as NIOSH but with improvements and additional Canadian requirements. The CSA Group now offers a certification program for respirators against the CSA Z94.4.1-21 performance standard for FFRs. Now that the new Canadian standard has launched, the CSA Group will certify to the new standard exclusively as opposed to the IO guidance. You can find further information on the regulatory considerations for FFRs in Health Canada's notice on the newly published standard and certification program.

NIOSH certification

To maintain NIOSH approval, respirators must:

• meet standard prescribed conditions of use
• follow the labelling standard and requirement in 42CFR84

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

• lot number
• model number
• filter designation
• exterior markings
• TC approval number

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.

Canadian and international standards comparable to NIOSH

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:

• Canada
• China
• Korea
• Europe
• Australia and New Zealand

Canada

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:

• demonstration of biocompatibility
• head strap strength performance
• fit testing

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:

• identifying the level of breathability of the respirators by their inhalation/exhalation resistance results on the packaging for users
• better sampling representation in the inhalation/exhalation testing as well as the fit testing
• detailed descriptions for particulate filtration and mechanical strength testing
• new descriptive designations (for example, CA-N95-175 Pa)
• increasing the minimum fluid resistance testing to match the highest level

China

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

• labelled filter efficiencies appear on respirator and packaging for KN90, KN95, KN100, KP90, KP95 and KP100
• the respirator and packaging lists the standard complied with
• the respirators:
  • have an ear loop design
  • are tested for leakage
  • are not fit tested to a panel

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

• labelled filter efficiency levels:
  • Level 1 (≥95%)
  • Level 2 (≥99%)
  • Level 3 (≥99.97%)
    • either the level or filtration efficiency is required together with the statement "protective face mask for medical use"
• the packaging lists the standard complied with
• the masks must be labelled as fluid resistant and flame resistant
• the masks have a head harness and are subject to a fit testing panel

Korea KMOEL (Korea Ministry of Employment and Labour) - 2017-64

The labelling must include the:

• filter efficiency
• type of respirator
• the standard complied with

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

Europe (EN 149:2001+A1:2009)

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

Labelled filter efficiencies must appear on the packaging:

• FFP2
• FFP3

The packaging and/or respirator lists:

• the standard complied with
• whether it is reusable (R) or not (NR)

Australia and New Zealand (AS/NZ 1716:2012)

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