Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Background
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.
Please review the notice on the new Canadian Z94.4.1 standard along with this guidance.
Published: August 25, 2020
Updated: February 2, 2021
On this page
- Overview of this guidance document
- Certification of FFRs
- Note about guidance documents in general
Overview of this guidance document
COVID-19 is an infectious disease caused by the SARS-CoV-2 coronavirus. The World Health Organization (WHO) declared a global pandemic in March 2020 and the Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 on March 18, 2020. A second Interim Order was introduced on March 1, 2021 and replaced the first one and on February 21, 2022, Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19 replaced the second Interim Order. The Interim Order (IO) expedites the authorization of Class I to IV medical devices used for COVID-19.
- sets out the safety, effectiveness and quality requirements for filtering facepiece respirators (FFRs)
- provides criteria for Canadian manufacturers developing respirators in Canada
The Government of Canada encourages manufacturers to consider the use of recycled fibres/fabrics, recyclable and/or sustainable components in the development of Canadian respirators.
This guidance document only deals with FFRs that cover the nose and mouth (partial or half FFRs). It does not address other types of particulate filtering respirators, such as full facepiece respirators or powered air-purifying respirators. It also does not offer recommendations for users.
The guidance document also outlines other requirements, such as:
- evidence of quality systems procedures
- in-line performance testing to confirm the Canadian-made FFR continues to meet the standard requirements
These minimum requirements are to be followed until a more formal Canadian national FFR standard and complimentary certification process is developed. However, any certification process would not exempt respirators from Health Canada's regulatory requirements.
Along with single-use FFRs, we also provide guidance for filtering half-facepiece elastomeric respirators that can be reused. These types of respirators do not have exhalation valves. They may be used instead of single-use half-facepiece filtering respirators during the COVID-19 pandemic.
Reusable respirators are tight-fitting half- or full-facepiece elastomeric respirators that:
- use replaceable filters, cartridges or canisters and
- have facepieces made of synthetic or natural rubber, which can be repeatedly cleaned, disinfected, stored and reused
Certification of FFRs
N95, N99 and N100 respirators are FFRs certified by the U.S. National Institute for Occupational Safety and Health (NIOSH). FFRs were developed mainly to filter out airborne particulates of a certain size and for use in an industrial setting.
Of these 3 respirators, N95 respirators have been adopted for use in health care settings as protection against influenza and infectious diseases (for example, tuberculosis). WHO's interim guidance and the U.S. Occupational Safety and Health Administration (OSHA) both indicate that N95 respirators can be used to reduce the spread of COVID-19.
Canada's national standard, CAN/CSA-Z94.4-18, outlines the selection, use and care of respirators. The Guidance on safety and performance specifications for filtering facepiece respirators provides technical, labelling and quality requirements for Canadian companies seeking to manufacture new respirators in Canada. While a national respirator standard was in development, companies used this guidance while the interim order (IO) was in effect. However, the new CSA-Z94.4.1-21 Performance of filtering respirators standard has now been published. Health Canada now encourages manufacturers and the general public to adopt this standard for FFRs. We based our 95 PFE IO requirements on the new CSA Z94.4.1 standard. The standard has also been enhanced when compared to the IO and NIOSH requirements.
This respirator guidance is in effect until:
- the IO expires and/or
- a national standard and Standards Council of Canada (SCC)-accredited certification scheme for respirators is developed in Canada
The CSA group has now established the first accreditation program to the CSA Z94.4.1 national respiratory standard.
Provinces and health care institutions are encouraged to adopt a program that allows for Canadian-certified respirators. This will assure the quality and performance of these FFRs.
The use of this guidance by Canadian manufacturers, and the designation of a "PFE" particulate filter efficiency level, has been prescribed prior to the creation of the CSA Z94.4.1 standard, and for manufacturers without NIOSH certification, but are instead tested in Canadian laboratories. However, now that the CSA Z94.4.1 standard is published, manufacturers will be expected to follow this new standard for designations, markings and other performance requirements, if they continue to maintain CSA certification.
Note about guidance documents in general
Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied by industry. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We must make sure that such requests are justifiable and that decisions are clearly documented.
Health Canada has also published a guidance document to help manufacturers prepare applications submitted under the IO. This guidance document should be read with this document.
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