Safety and performance specifications for respirators during COVID-19: Guidance for Canadian manufacturers

Date published: August 25, 2020

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Background

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. The interim order (IO) expedites the authorization of Class I to IV medical devices used in relation to COVID-19.

This document provides guidance for Canadian manufacturers on the minimum technical requirements for facepiece filtering respirators (FFR). Facepiece filtering respirators consist of either an N95 equivalent FFR (for example,”95PFE” or respirator with 95% particulate filter efficiency) or an elastomeric respirator with equivalent filtration performance. These minimum requirements are to be followed until a more formal Canadian national FFR standard and certification process is developed.

This guidance document only deals with respirators that cover the nose and mouth (partial or half facepiece respirators). It does not deal with other types of particulate filtering respirators (for example, full facepiece respirators). The guidance does not offer recommendations for users.

N95, N99 and N100 respirators are FFRs tested 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 in particular have been adopted for use in health care settings, as protection against influenza and other infectious particles (for example, M. tuberculosis). Both WHO’s interim guidanceFootnote 1 and a toolkit by the U.S. Occupational Safety and Health Administration (OSHA)Footnote 2 suggest they can be used as a component of personal protective equipment (PPE) for use during the COVID-19 pandemic to reduce the spread of infection.

Canada’s national standard, CAN/CSA-Z94.4-18, outlines the selection, use and care of respirators. This standard is based partially on NIOSH testing and quality requirements. Given the familiarity and trust in NIOSH-certified respirators, many employers use NIOSH-certified respirators in the selection of their FFRs. During the COVID-19 pandemic, there is a high demand for NIOSH-certified N95 respirators and consequently, a very low supply. NIOSH also recently announced suspension of new applications for N95 certification by manufacturers outside the U.S.

As a result, the Government of Canada has been working with external stakeholders to increase the domestic production of FFRs. However, the level of confidence in respirators not certified by NIOSH is low, and consequently respirators meeting equivalent standards are largely not sought or found acceptable. As well, Health Canada and our program partners, such as the Public Health Agency of Canada (PHAC) and National Research Council (NRC) supported by research and foundational work by the CSA Group, have collaborated to develop this guidance to fill a gap for Canadian manufacturers seeking to create alternative solutions to N95 respirators in Canada. PHAC and NRC have contributed to the development of testing of N95 and equivalent respirators during the COVID-19 pandemic.

The guidance for FFRs is in effect until the IO expires on March 18, 2021, or until a robust and Standards Council of Canada (SCC) accredited certification scheme is developed. The use of this guidance by Canadian manufacturers, and the designation of a “PFE” particulate filter efficiency level as opposed to “N” particulate filter efficiency level, has been proposed, as these respirators will not be certified by NIOSH but tested in Canadian labs (including at NRC, CSA or other SCC-accredited labs).

Health Canada has also published a guidance document to assist manufacturers in preparing applications submitted under the IO. This guidance document should be read in conjunction with this document.

Overview of FFRs

The facepiece of an FFR is made of material that can filter both larger- and smaller-sized aerosols due to their inherent properties.Footnote 3 There are several styles of FFRs, with the 2 most common being the cup style and flat fold style.

Elastomeric respirators are made of a molded facepiece to which a replaceable filtering cartridge or filter is attached. These respirators may be used as a component of personal protective equipment (PPE) within a health care or industrial/commercial setting.

Respirators are designed to protect the user from inhaling small particulates and aerosols, including infectious particulates. In Canada, the most frequently purchased respirators are those that meet NIOSH standards and where the manufacturer is certified by NIOSH as an FFR manufacturer.

As part of the NIOSH certification process, a built-in framework helps to ensure that the quality and testing requirements for respirators it certifies are maintained post-certification.

Canada does not have a certification body like NIOSH. However, as part of the IO process, Canadian manufacturers are required to follow a common set of requirements, including labelling requirements for the filtration efficiency rating. Manufacturers will be encouraged to label their product as a 95PFE, 99PFE or 100PFE respirator.

Other requirements outlined in this guidance include:

We will be issuing conditional IO authorizations during the pandemic (and while NIOSH has suspended its certification process outside the U.S.) to provide some checks and balances for Canadian-made FFRs. These authorizations will set out the:

FFRs provide a minimum 95% filtration protection for the wearer against small aerosolized particulates. The results of the NIOSH particulate filter efficiency test must meet or exceed 95% filtration of the aerosolized particles. They must also confirm that the mask is breathable for the user.

FFRs can pass other standards to qualify as a surgical respirator, including passing additional flammability and fluid resistance tests. (Guidance for both non-surgical/standard FFRs and surgical “95PFE” FFRs is provided later in this document.)

Along with “95PFE” FFRs designed for single-use, we also provide guidance for elastomeric respirator designs intended for re-use. Reusable elastomeric respirators may be used as an alternative to single-use half-facepiece filtering respirators during the COVID-19 pandemic. Reusable respirators are tight-fitting half- or full-facepiece elastomeric respirators that:

Elastomeric reusable FFRs may have exhalation valves incorporated into their design to help with breathability and comfort. Any FFR or elastomeric respirator with an exhalation valve should not be used in a setting where:

FFR performance criteria

All Canadian-manufactured respirators must meet the minimum performance testing requirements (see Table 1). Manufacturers will be asked during the application process to provide samples, which will be sent for testing to the NRC facility.

Test samples submitted for approval must be regular production units from actual manufacturing processes (for example, not prototypes). Applicants should attest to this in their submission. Samples from applicants that cannot attest the products tested have gone through the manufacturer’s production-level assembly, inspection and test process will be considered pre-testing. If upon review of the pre-testing samples they are found to be acceptable, we may issue a conditional IO authorization until the manufacturer can provide the test samples.

Table 1. 95PFE FFR 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) kg weight force for each headstrap tested
Breathing resistance/differential pressure Inhalation: <35 mmH2O (343.2 Pa)Footnote 4
Exhalation: <25 mmH2O (245.2 Pa)Footnote 5
Fit (each size)

CAN/CSA Z94.4
10 subjects total as identified in the NIOSH facial panel (RCT-APR-STP-0005-05a-06, revision 3.0)
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

Exhalation valve leak testing (only for reusable respirators with an exhalation valve) NIOSH (TEB-APR-STP-0004):Footnote 6 <30 ml/min

Additional information on these performance testing requirements

Biocompatibility

Each final finished component must be biocompatible in accordance with the tests for devices in limited contact (≤24 hrs) with skin, in accordance with ISO 10993-1. This requires testing facial covering materials, headstrap or head harness and clasps or other components that touch the user’s head for:

This data should be based on test samples representative of the finished device. Alternatively, a rationale can be provided describing the testing that was conducted on similar device and how that testing is reflective of the subject device’s end product.

Particulate filtration

Particulate filtration is required in accordance with NIOSH TEB-APR-STP-0059.Footnote 9 Any exceptions to this test method should be documented and justified, such as deviations in:

Health Canada would accept both deviations on the basis of the manufacturer providing an acceptable scientific rationale and testing methodology. For example, an acceptable rationale for the salt loading level may be the amount of time the samples are challenged by the flow of aerosol before the results could be recorded. The mass of the salt loaded in about 5 minutes is expected to be much larger than the mass loading of particles expected from several days of use filtering ambient air in a hospital or other non-industrial setting.

Mechanical headstrap strength

The headstrap should be able to withstand a force of 10 N (0.98) kg when stretched. This break strength should be applied to each strap (for example, if there are 2 straps, a force of 20 N would be expected to be exceeded). A sample size of 10 is recommended.

Breathing resistance/differential pressure

A differential pressure test is used as an indicator of breathability in accordance with NIOSH inhalation and exhalation test methods (TEB-APR-STP-0007 and TEB-APR-STP-003, respectively). For elastomeric respirators, a head form is needed to conduct this test.

The resistance to airflow is measured using a particulate respirator mounted on a test fixture with air flowing at a continuous rate of 85 ±2 L/min.

The maximum resistance requirement as indicated in mm of the water-column height shall be no greater than 35 mmH2O (343.2 Pa) for the inhalation measurement and 25 mmH2O (245.2 Pa) for the exhalation measurement.

Fit testing

Quantitative face fit testing should be performed TSI PortaCount tester (or equivalent device) in accordance with CSA Z94.4-18. A total of 10 subjects should be tested according to the NIOSH facial panels identified in RCT-APR-STP-0005-05a-06, revision 3.0.Footnote 10 The subject performs 7 exercises (in accordance with section B.2.5 of CSA Z94.4-18). A fit factor result of 100 or greater for each subject is required for a pass. Testing should be performed on the entire panel per model per size. The minimum requirements are as follows:

Exhalation valve leak testing

If the respirator has an exhalation valve, the leakage of the valve must pass the following minimum requirements tested in accordance with NIOSH TEB-APR-STP-0004Footnote 11:

Special considerations for elastomeric respirators

Particulate filter efficiency and breathing resistance

All of the above requirements apply to elastomeric respirators. However, manufacturers should note the following guidelines for the 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. ReusableFootnote 12 respirators are to be cleaned and disinfected after each use, according to the Occupational Health and Safety Administration (OSHA) hospital and respiratory toolkit.Footnote 13 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 handle a significant or worst-case microbial load (for example, 6 log reduction of bacterial spores).

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

  1. particulate filtration efficiency and breathing resistance for the cartridge or filter as it is intended to be usedFootnote 15
    • further penetration and breathability tests after cleaning and disinfection are not necessary if the cartridge and filter are to be discarded after each use or shift
  2. fit testing
  3. mechanical stability of the head strap or head harness
  4. flammability and fluid resistance testing (for example, if surgical FFR claims are being made)

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

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

Filter reuse conditions

The manufacturer should indicate recommendations for filter replacement in the labelling. These recommendations should be justified (with evidence) in the IO submission. 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 will need to provide the appropriate testing demonstrating 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 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.

Other requirements for filtering facepiece respirators with fluid resistance properties (surgical respirators)

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

Table 2. Threshold test requirements for surgical N95 FFRs
Test Requirements
Flammability 16 CFR 1610Footnote 16
or CAN/CGSB 4.2 No. 27.5Footnote 17
Class 1 (≥3.5 s flame spread)
Fluid resistance ASTM F1862M-17Footnote 18
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 either the U.S. flammability standard (CPSC CS-191-53 flammability test method, 16 CFR Part 1610) or Canadian flammability standard (CAN/CGSB 4.2 No. 27.5). These similar test standards both meet the same Class I requirement for non-raised fabrics, as outlined in the ASTM 2100 standard for surgical masks.Footnote 19 Testing should be conducted on all finalized materials.

Fluid resistance

Fluid resistance may be met if the respirator passes testing is in accordance with the ASTM F1862 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 (levels 1, 2 or 3 barrier) 80, 120 and 160 mm Hg, respectively. 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 include, but are not limited to:

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.

Other components of an IO respirator submission

Along with the performance testing requirements outlined above, the IO submission should include the following (for all IO respirator submissions for made-in-Canada solutions):

Device description

The device description must include:

  1. engineering drawings
  2. material specifications (a detailed chemical and physical identification of all materials used in the final components of the respirator)
  3. a description of the intended use for the device

Engineering drawings

Engineering drawings are to be completed and submitted for each product. They must include critical and major dimensions of the product (for example, as defined within the design specifications and/or acceptability criteria outlined in Appendix 1). All product components must be labelled and the same labels are to be used for the material specifications. Engineering drawings are to display all views of the product, including any cut-outs that are considered necessary.

Any changes to the engineering drawings must be submitted to Health Canada before the changes are implemented.

Material specifications

The material specifications consist of a list of components used to assemble the product. The components are to be identified as critical or non-critical. Any component that will influence the fit, form or function of the product are considered “critical.”

The components must be identified using labels in the engineering drawings. Specifications for all critical components as well as associated tolerances are to be identified. Tolerances must be within reason to ensure that the fit, form or function of the product is not influenced by reaching the limits of the tolerances. For example:

Any changes to the material specifications must be submitted to Health Canada before the changes are implemented.

Intended use

The intended use of the device is a description of the device (for example, what it does, key performance characteristics) and how it is intended to be used (for example, clinical use). This may also include limitations due to temperature, storage, reuse/cleaning and disinfection, and so on.

Shelf life

Storage conditions (for example, temperature, humidity) and useful life of the product (validated by shelf-life tests) should be provided. This validation testing is to be provided in the IO submission. The shelf life of the device and the filter components should be indicated in the product labelling.

Labelling

Labelling requirements are outlined in the following sections.

Standardized markings for Canadian Respirators

Table 3 lists the markings that should be indicated on all FFRs manufactured in Canada. Table 4 details the labelling notations that are required.

Table 3. Canadian manufactured respirator protection level and associated identification
Identification Performance Test method
95PFE Greater than or equal to 95% particulate filter efficiency

http://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf

99PFE Greater than or equal to 99% particulate filter efficiency
100PFE Greater than or equal to 99.97% particulate filter efficiency
95PFE-L# Greater than or equal to 95% particulate filter efficiency
Fluid resistance to specified ASTM level 1, 2 or 3.  # will represent 1, 2 or 3, whichever is the highest level obtained by product

http://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf

ASTM F1862 standard test method for resistance of medical face masks to penetration by synthetic blood

U.S. flammability standard (CPSC CS-191-53 flammability test method (16 CFR Part 1610 or Canadian flammability standard (CAN/CGSB 4.2 No. 27.5)

99PFE-L# Greater than or equal to 99% particulate filter efficiency
Fluid resistance to specified ASTM level 1, 2 or 3.  # will represent 1 , 2 or 3, whichever is the highest level obtained by product
100PFE-L# Greater than or equal to 99.97% particulate filter efficiency
Fluid resistance to specified ASTM level 1, 2 or 3.  # will represent 1 , 2 or 3, whichever is the highest level obtained by product
Table 4. Labelling notation expected on the respirator itself
Labelling instructions FFR Elastomeric respirator Filters for elastomeric respirator
Name and model number of device Yes Yes Yes
Name of Manufacturer Yes Yes Yes
Product Level of protection (see Table 3) Yes No* Yes*
Health Canada IO authorization number Yes Yes Yes

Note: For elastomeric respirators, the production level (as per filtration level or protection achieved after testing the whole mask) will be marked on the filter itself.

It is recommended that respirator and filter markings (see Table 4) be included on the respirator itself. For example on a single-use FFR, include the name and model number of the device, name of manufacturer, level of protection (see Table 3) and Health Canada IO authorization (also the IO application number). For an elastomeric respirator, include the same information with the exception of the product level of protection (in this case, these would be included on the filters to be used with the elastomeric respirator).

Packaging labelling

The packaging must include the following:

Also include the following cautions and limitations:

Cautions and limitations:

Quality management

In accordance with the IO, manufacturers must  either:

Quality management will be assessed both before and after IO authorization:

Both steps in the post-authorization review are conditions of IO authorization for Canadian manufacturers of FFRs.

Manufacturing process

The manufacturing process may be described in detail using a flow chart or in text form. Include details throughout the entire process, from the receipt of raw materials to the finished product. Be sure to specify the process used to perform operations, such as welding headstraps.

Note: Changes to key suppliers, materials, fit, form or function of the respirator or the manufacturing process during the IO process must be submitted to Health Canada before they are implemented. After authorization, any changes must be submitted in the form of an IO amendment to Health Canada. We will review the effects of such changes. Authorization will be required before these post-authorization changes are implemented.

Quality control plan

The submission should include a quality control plan that identifies which steps in the manufacturing process require process validation (see Appendix 1). This validation process should be addressed as part of the sampling plan and acceptance criteria. 

Sampling plan and acceptance criteria

A detailed sampling plan, along with the acceptance criteria, forms part of the IO submission. It should follow the outline provide in Appendix 1.

The plan must demonstrate that systems are set in place to ensure the quality of the respiratory protection provided by the respirator. For reference, please see the plan used in NIOSH-certified respirators.

The sampling plan should follow internal standards for sampling by:

Alternatively, the MIL-STD-414 and MIL-STD-105E may also be used.

The sampling procedure must also include a list of the characteristics to be tested by the manufacturer. The characteristics listed need to be classified according to their potential effect. The sampling plan and acceptance criteria should be provided for review and approval by Health Canada in the IO submission and must include the contents outlined in Appendix 1.

Quality control records

A quality control records plan should be provided in the IO submission. Quality control records are to be kept and maintained and are subject to the following requirements under this IO. The manufacturer must also attest to the plan in writing and should provide a summary of the plan that outlines the methods and measures to be followed.

For the purpose of the COVID-19 IO, the applicant is required to keep quality control inspection records. These must be sufficient to carry out the procedures (for example, as outlined in ASTM E2762 for sampling by variables or ASTM E2234 for sampling by attributes).

Note: Any changes to any part of the submission (including, but not limited to, the indications for use, engineering drawings, materials specifications, manufacturing process or plan, materials or product design) during the IO process must be submitted to Health Canada before changes are implemented. If changes are made following an IO authorization, the manufacturer must submit those in the form of an IO amendment to Health Canada, as these may trigger changes in performance and/or acceptability criteria.

Conditions of IO authorization

All authorized IOs will be subject to conditions of continued quality as determined by Health Canada at the time of IO authorization, if granted. These may include, but are not limited to, ongoing evidence of safety, effectiveness (for example, performance criteria) and quality. These are determined through:

See Appendix 2 for an IO submission checklist for made-in-Canada respirators.

Appendix 1: Quality control plans - contents

The quality control plan is to be provided and must include:

Appendix 2: Checklist for IO submission

# Item Check
1 Engineering drawings  
2 Materials specifications  
3 Intended use  
4 Biocompatibility test results  
5 Particulate filter efficiency  
6 Breathing resistance/differential pressure  
7 Fit testing  
8 Exhalation valve (if applicable)  
9 Elastomeric respirator-specific PFE and breathability testing (if applicable)  
10 Cleaning and disinfection (if applicable)  
11 Filter reuse conditions (if applicable)  
12 Flammability (if applicable)  
13 Fluid resistance (if applicable)  
14 Other testing (if applicable) for any additional labelling claims  
15 Mask labelling representation (as directed in tables 3 and 4)  
16 Packaging labelling (all information to be marked on packages or provided to the user)  
17 Quality management arrangements: manufacturing process flow chart  
18 Manufacturing process outline  
19 Sampling plan and acceptance criteria  
20 Quality control records plan  

Footnotes

Footnote 1

World Health Organization. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance, March 27, 2020.

Return to footnote 1 referrer

Footnote 2

Joint publication with the U.S. Department of Labor, OSHA, Department of Health and Human Services, NIOSH and CDC. Hospital Respiratory Protection Program Toolkit: Resources for Respirator Program Administrators (May 2015).

Return to footnote 2 referrer

Footnote 3

Fischer EM, Noti JD, Lindsley WG, Blanchere FM, Shaffer RE (2014). Validation and application of models to predict facemask influenza contamination in health care settings. Risk Analysis, August 2014; 34(8): 1423-1434.

Return to footnote 3 referrer

Footnote 4

NIOSH. TEB-APR-STP-007 Rev 2.3, March 8, 2019. Determination of Inhalation Resistance Test, Air-Purifying Respirators Standard Testing Procedure (STP). http://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0007-508.pdf

Return to footnote 4 referrer

Footnote 5

NIOSH. TEB-APR-STP-003 Rev 2.4, March 15, 2019. Determination of Exhalation Resistance Test, Air-Purifying Respirators Standard Testing Procedure (STP). http://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0003-508.pdf

Return to footnote 5 referrer

Footnote 6

National Institute for Occupational Safety and Health National Personal Protective Technology Laboratory (NIOSH NPPTL). Determination of Exhalation Valve Leakage Test, Air-Purifying Respirators Standard Test Procedure. Rev 2.2, March 22, 2019. https://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0004-508.pdf

Return to footnote 6 referrer

Footnote 7

ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.

Return to footnote 7 referrer

Footnote 8

ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization.

Return to footnote 8 referrer

Footnote 9

NIOSH. Determination of Particulate Filter Efficiency Level for N95 Series Filters Against Solid Particulates for Non-powered, Air-purifying respirators Standard Testing Procedure (STP). TEB-APR-STP-0059, Rev 3.2, December 13, 2019. http://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf

Return to footnote 9 referrer

Footnote 10

IOSH. Determination of Qualitative Isoamyl Acetate (IAA) Facepiece Fit, Air-Purifying Respirators Standard Testing Procedure (STP). RCT-APR-STP-0005-05a-06, Revision 3.0, December 20, 2018. https://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0005-05a-06-508.pdf

Return to footnote 10 referrer

Footnote 11

NIOSH. Determination of Exhalation Valve Leakage Test, Air-Purifying Respriators. TEB-APR-STP-0004, Rev 2.2, March 22, 2019. http://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0004-508.pdf

Return to footnote 11 referrer

Footnote 12

Joint publication with US Department of Labor, OSHA, Department of Health and Human Services, NIOSH and CDC. Hospital Respiratory Protection Program Toolkit: Resources for Respirator Program Administrators (MAY 2015).

Return to footnote 12 referrer

Footnote 13

Joint publication with US Department of Labor, OSHA, Department of Health and Human Services, NIOSH and CDC. Hospital Respiratory Protection Program Toolkit: Resources for Respirator Program Administrators (MAY 2015).

Return to footnote 13 referrer

Footnote 14

Bessesen M, Adams JC, Radonovich L, Anderson J [2015]. Disinfection of Reusable Elastomeric Respirators by Health Care Workers: A Feasibility Study and Development of Standard Operating Procedures. American Journal of Infection Control 43(6): 629-634.

Return to footnote 14 referrer

Footnote 15

Note that if the cartridge and filter is intended to be discarded following each use or shift, then penetration testing and breathability need not be retested following cleaning and disinfection.

Return to footnote 15 referrer

Footnote 16

United States Consumer Product Safety Commission. Laboratory Test Manual for 16 CFR Part 1610: Standard for the Flammability of Clothing Textiles. October 2008. https://www.cpsc.gov/PageFiles/115435/testapparel.pdf

Return to footnote 16 referrer

Footnote 17

CAN/CGSB 4.2 No. 27.5, Textile Test Methods – Flame Resistance – 45o Angle Test – One Second Flame Impingement.

Return to footnote 17 referrer

Footnote 18

ASTM. F1862M-17. Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity).

Return to footnote 18 referrer

Footnote 19

ASTM. F2100-19. Standard Specification for Performance of Materials Used in Medical Face Masks.

Return to footnote 19 referrer

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