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Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Performance criteria

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

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Performance testing requirements

All Canadian-manufactured respirators must meet the minimum performance testing requirements (see Table 1). Manufacturers may be requested to provide samples as part of the application process for additional testing.

Test samples used in testing submitted for approval must be regular production units from actual manufacturing processes (not prototypes). Applicants should attest to this in their submission. Samples from applicants that have not gone through the manufacturer’s production-level assembly, inspection and test process will be considered pre-testing.

If the pre-testing sample performance is acceptable, Health Canada may issue a conditional IO authorization until the manufacturer can provide regular production unit samples for testing.

Table 1. Respirator performance testing requirements
Test Requirements

Biocompatibility (each patient skin contacting component)

ISO 10993-5 (cytotoxicity) and

ISO 10993-10 (skin sensitization and hypersensitivity)
Materials must be non-cytotoxic, non-sensitizing and non-allergenic

Particulate filter efficiency

NIOSH 42 CFR 84 (TEB-APR-STP-0059)

≥95%

Mechanical strength of headstrap or head harness

Ability to withstand a 10 N (0.98 kgf) weight force for each headstrap tested

Airflow resistance

Fit (each size)

CAN/CSA Z94.4 (Annexes B and C)

18 subjects total as identified in the NIOSH facial panel (RCT-APR-STP-0005-05a-06, revision 3.0, section 8.5 NIOSH panel)
Panel fit requirements:

  • 1 size: >60%
  • 2 sizes: >80%
  • 3 or more sizes: 90%

Minimum pass is a fit factor of 100 for each subject

Additional information on these requirements

Biocompatibility

Each final finished component that touches the skin should be biocompatible. This is in accordance with the tests for devices where there’s limited contact (≤24 hrs) with skin, as outlined in ISO 10993-1. This requires testing facial covering materials, headstraps or head harnesses and clasps or other components that touch the user’s head for:

Testing should be conducted on samples that represent the finished device. As an option, manufacturers may provide a rationale that describes testing conducted on a similar device and how this compares to the device in question.

Particulate filtration

Particulate filtration is required in accordance with NIOSH TEB-APR-STP-0059. Any exceptions to this test method should be documented and justified, such as deviations in:

Health Canada will accept these deviations if the manufacturer provides an acceptable scientific rationale and testing methodology. For example, an acceptable rationale for reduced salt loading level may be consistency with the maximum expected particle loading of the FFR being used to filter ambient air in a hospital or other non-industrial setting.

A sample size of 14 is the minimum recommended.

Mechanical headstrap strength

Each connection point of each head strap to the respirator body should be tested using a pull force gauge that can measure 10 N (0.98 kgf) in a direction perpendicular to the plane of affixation for 10 (±2) seconds. The force is pulled in a direction perpendicular to the plane of affixation when the respirator is mounted on a head form in accordance with the information supplied by the manufacturer for proper donning.

During the test, it is acceptable if the direction of the force shifts from the plane of affixation. The force is applied progressively to avoid an initial shock or a jerking motion to the connection.

During and after force is applied, the test has failed if one of the following occurs:

A sample size of 10 finished respirators is recommended.

Airflow resistance

In accordance with NIOSH inhalation and exhalation test methods (TEB-APR-STP-0007 and TEB-APR-STP-003, respectively), the airflow resistance tests demonstrate the breathability of a respirator. Airflow resistance for respirators when tested at 85±2 l/min is to satisfy:

A minimum of 20 samples is required and all the samples must pass this requirement.
For elastomeric respirators, a head form is needed to conduct this test.

Fit testing

Each size of respirator model must undergo a fit test. Quantitative face fit testing using a TSI PortaCount tester (or equivalent device) should be performed in accordance with CSA Z94.4-18. Annex B of CSA Z94.4-18 outlines the 7 exercises and Annex C outlines the full protocol for the quantitative fit test procedure.

Eighteen people should be selected to conduct this testing, in accordance with the NIOSH facial panels identified in section 8.5 of RCT-APR-STP-0005-05a-06, revision 3.0. A fit factor result of 100 or greater for each person is required for a pass. Testing should be performed on the entire panel.

The minimum requirements are as follows:

Special considerations for elastomeric respirators

Particulate filter efficiency and breathing resistance

All of the above requirements apply to elastomeric respirators.

However, there are also guidelines for particulate filtration efficiency and breathing resistance testing for the cartridge or filter as it is intended to be used. For example, the test setup should reflect the following:

Cleaning and disinfection

Elastomeric respirators should be cleaned and disinfected according to the manufacturer’s validated cleaning and disinfection instructions. Reusable respirators are to be cleaned and disinfected after each use, according to the Occupational Health and Safety Administration (OSHA) hospital and respiratory toolkit. Some examples of guidance include:

A validation protocol should be created to provide evidence that the process chosen adequately cleans and disinfects the reusable parts of the respirator. The microbial challenge organism should reflect a worst-case scenario organism for the chosen technology or method of disinfection. Also, the cleaning and disinfection procedure should demonstrate that the most difficult areas of the respirator can be decontaminated successfully after an intermediate-level disinfection, or better.

Cleaning and disinfection validation testing throughout the process, involving the maximum number of cycles, should be followed by 4 tests:

All testing should be conducted on final products in production form.

If further performance claims are made (for example, antibiotic effectiveness, anti-viral), other validation tests through to the maximum number of cleaning and disinfection cycles will be requested.

Filter reuse conditions

The manufacturer should provide recommendations for filter replacement in the labelling. For example, the manufacturer should provide instructions for the make and models of the specific filters and/or cartridges, which may be used with their respirator model.

The manufacturer needs to justify these recommendations in the IO submission. For example, the manufacturer should provide evidence that the efficiency and other performance criteria are acceptable when used with the respirator. 

OSHA only requires replacing filters “where necessary” (for example, when soiled, contaminated or clogged). However, there are no known studies addressing safety during prolonged wear of these devices, specifically in relation to COVID-19.

Manufacturers that suggest prolonged filter wear must define the time frame of “prolonged wear” and communicate this in the labelling. They must also validate through testing that prolonged wear does not affect filtration performance.

Requirements for surgical respirators

Other tests are required to meet the minimum threshold of the surgical N95 equivalent. These tests are outlined in Table 2.

Table 2. Threshold test requirements for surgical N95 FFRs
Test Requirements

Flammability

16 CFR 1610.7
Class 1 (≥3.5 s flame spread)

Fluid resistance
  • ASTM F1862M-17
  • ASTM Level 1 for 80 mm Hg
  • ASTM Level 2 for 120 mm Hg
  • ASTM Level 3 for 160 mm Hg

Flammability

Flammability testing should be conducted in accordance with the U.S. flammability standard (CPSC CS-191-53 flammability test method, 16 CFR Part 1610.7). This test standard meets the Class 1 requirement for non-raised fabrics, as outlined in the ASTM F2100 standard for surgical masks. Testing should be conducted on all final materials.

Fluid resistance

Fluid resistance is tested using the ASTM F1862-17 standard test method for resistance of surgical mask to penetration by synthetic blood (or a comparable test method) at any specific velocity as identified in the labelling. Respirators are tested on a pass or fail basis at specified velocities (low, middle or maximum).

The requirements for this test are outlined in ASTM F2100-19 (levels 1, 2 or 3 barrier). Standard fluid velocities used in this test method (ASTM F1862) are 450, 550 and 635 cm/s. These correspond to blood pressures of 10.7 kPa (80 mmHg), 16.0 kPa (120 mmHg) and 21.3 kPa (160 mmHg). The maximum level reached should be reported in the labelling.

Other claims requiring testing validation

Any additional claims in the labelling must be supported with validation testing. Such claims may include the following:

Other technologies that have been integrated into the device (for example, antimicrobial or viral coating, nanoscale technologies, drug delivery system) may need to be assessed separately. Health Canada will advise and/or coordinate.

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