NIOSH N95 designation for filtering facepiece respirators (FFR)
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- NIOSH N95 respirators and their use in Canada
- NIOSH certification
- International standards comparable to NIOSH
NIOSH N95 respirators and their use in Canada
The US National Institute of Occupational Safety and Health (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):
- are labelled with the performance standard with the corresponding designation (for example, N95 or KN95), and
- meet all aspects of the performance standard, including labelling
If neither of the above are present, the product must state that it is not NIOSH-approved. In the absence of this statement, the product may be considered misleading.
Health Canada expects that respirators that conform to NIOSH or similar international 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 21-23 of the MDR.
Canada has no national standard for FFRs at this time. However, Health Canada has created the 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 has also launched a new certification program for respirators, providing Canadian manufacturers with an alternative certification to that of NIOSH, while still upholding similar standards of safety, effectiveness and quality.
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:
- 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
The appropriate markings are shown on this generic FFR.
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.
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:
- Australia and New Zealand
While currently there is no Canadian national standard, Health Canada recognizes manufacturers who conform to the Canadian respirator guidance specifications in conjunction with 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 are based on NIOSH requirements for filtration performance and inhalation/exhalation performance. They also include options for surgical respirators in compliance with US 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 that manufacturers demonstrate stability testing and provide evidence of quality systems manufacturing procedures.
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 KN90, KN95, KN100, KP90, KP95, 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:
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%).
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