Specifications for COVID-19 Products

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Table of Contents

In support of the Government of Canada’s response to Coronavirus disease (COVID-19), we are providing the specifications for the various types of products below:

Disposable N95 masks

Disposable surgical masks

Nitrile gloves / Vinyl gloves

Gowns and coveralls

Eye protection

Hand sanitizer

ICU-level Ventilators / Ventilators

Thermometers

Disposable N95 masks

    Specifications for filtering face pieces (NIOSH N95 and alternatives):

Table 1: NIOSH N95 specifications
Surgical N95 NIOSH under 42 CFR Part 84 and
FDA/NIOSH MOU 225-18-006
Commercial N95 NIOSH under 42 CFR Part 84
Labelling Information on respirator
(1) Manufacturer’s Name; (2) TC-84A-####; (3) NIOSH; (4) Lot Number; (5) Filter designation (i.e. N95)
Additional information 1
Nasal splints
Must be adjustable and provide an airtight seal.
Mask Harness
  • Head straps are typical, Earloops are extremely uncommon
  • Earloops are considered a novel head harness and must ungergo additional NIOSH testing
  • 2.2kg per strap
Fit
Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes, either: (1) By providing more than one facepiece size; or (2) By providing one facepiece size which will fit varying facial shapes and sizes.
Filter performance – (must be ≥ X% efficient)
≥ 95%
≥ 95%
Test agent
Sodium Chloride (NaCl) Particles
Sodium Chloride (NaCl) Particles
Flow rate
85 L/min
85 L/min
Inhalation Resistance
≤ 343 Pa
≤ 343 Pa
Flow rate
85 L/min
85 L/min
Exhalation Resistance
≤ 245 Pa
≤ 245 Pa
Flow rate
85 L/min
85 L/min
Synthetic Blood Penetration
  • 2ml of synthetic blood spayed on mask at 10.7kPa, 16.0kPa and 21.3kPa, no penetration at an acceptable quality limit of 4.0%
  • Tested on a PASS/FAIL basis at a specified velocity/pressure
  • ASTM F1862
N/A
Surface Wetting Resistance
N/A
N/A
Microorganism Index (Bioburden)
N/A
N/A
Biological Filtration Efficency
≥ 95%
N/A
TIL (total inward leakage)
N/A
N/A
Exhalation valve leakage requirement
-
Leak rate 30 mL/min
Force applied
-
-245 Pa
CO2 clearance
N/A
N/A

1 https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource1quest2.html

Table 2: KN95 specifications
Medical KN95 (GB 19083-2010)
Commercial KN95 (GB2626-2006)
Labelling Information on respirator
  • Number and year of publication of standard
  • Type and grade of filter elements (i.e. KN95)
Nasal splints
Must be adjustable
N/A
Mask Harness
  • No less than 10 Newton (1kg) per strap
  • Earloops Are Allowed
Fit
The mask shall be designed as to provide a good fit and overall fit factor of the mask shall not be less than 100
The disposable facepiece structure shall ensure the tight fitting with face, and be free from deformation during the service life.
Filter performance – (must be ≥ X% efficient)
≥ 95%
≥ 95%
Test agent
Sodium Chloride (NaCl) Particles
Sodium Chloride (NaCl) Particles
Flow rate
85 L/min
85 L/min
Inhalation Resistance
≤ 343.2 Pa
≤ 350 Pa
Flow rate
85 L/min
85 L/min
Exhalation Resistance
N/A
≤ 250 Pa
Flow rate
N/A
85 L/min
Synthetic Blood Penetration
2ml of synthetic blood spayed on mask at 10.7kPa and no penetration shall occur on inner side of mask
N/A
Surface Wetting Resistance
Outside surface spray rating shall not be less than specified in Grade 3 of GB/T47-45-1997
N/A
Microorganism Index (Bioburden)
  • Total bacteria count ≤200 CFU/g
  • Total fungus colony count colony count CFU/g ≤100
  • Coliform bacteria: Not Detectable
  • Pseudomonas areginosa: Not Detectable
  • Staphylococcus aureus : Not Detectable
  • Hemolytic streptococcus: Not Detectable
N/A
Biological Filtration Efficency
N/A
N/A
TIL (total inward leakage)
N/A
  • TIL of at least 46 actions of 50 actions in all, in the case of TIL of each action as the evaluation basis (namely 10 testees × 5 actions) KN95 <11%
  • Total TIL of at least 8 testees of 10 testees in all, in the case of total TIL of each testee as the evaluation basis KN95 <8%
Exhalation valve leakage requirement
-
Depressurization to 0 Pa ≥ 20 sec
Force applied
-
-1180 Pa
CO2 clearance
N/A
≤ 1%
Table 3: Other international specifications
CE FFP2 (EN149-2001)
P2 (AS/NZ 1716:2012)
Korea 1st Class (KMOEL – 2017-64)
DS (Japan JMHLW-Notification 214, 2018)
Labelling Information on respirator
• Manufacturer logo
• CE Labelling Number and year of publication of standard
• Filter designation (i.e. FFP1, FFP2 or FFP3)
• Number and year of publication of standard
• Filter designation (i.e. P2)
• Number and year of publication of standard
• Filter designation (i.e. Korea 1st Class)
• Number and year of publication of standard
• Filter designation (i.e. DS)
Filter performance – (must be ≥ X% efficient)
≥ 94%
≥ 94%
≥ 94%
≥ 95%
Test agent
NaCl and paraffin oil
NaCl
NaCl and paraffin oil
NaCl
Flow rate
95 L/min
95 L/min
95 L/min
85 L/min
Total inward leakage (TIL) 2 - tested on human subjects each performing exercises
≤ 8% leakage (arithmetic mean)
≤ 8% leakage (individual and arithmetic mean)
≤ 8% leakage (arithmetic mean)
Inward Leakage measured and included in User Instructions
Inhalation resistance – max pressure drop
≤ 70 Pa (at 30 L/min)
≤ 240 Pa (at 95 L/min)
≤ 500 Pa (clogging)
≤ 70 Pa (at 30 L/min)
≤ 240 Pa (at 95 L/min)
≤ 70 Pa (at 30 L/min)
≤ 240 Pa (at 95 L/min)
≤ 70 Pa (w/valve)
≤ 50 Pa (no valve)
Flow rate
Varied – see above
Varied – see above
Varied – see above
40 L/min
Exhalation resistance – max pressure drop
≤ 300 Pa
≤ 120 Pa
≤ 300 Pa
≤ 70 Pa (w/valve)
≤ 50 Pa (no valve)
Flow rate
160 L/min
85 L/min
160 L/min
40 L/min
Exhalation valve leakage requirement
N/A
Leak rate ≤ 30 mL/min
Visual inspection after 300 L/min for 30 sec
Depressurization to 0 Pa ≥ 15 sec
Force applied
N/A
-250 Pa
N/A
-1,470 Pa
CO2 clearance requirement
≤ 1%
≤ 1%
≤ 1%
≤ 1%

2 Japan JMHLW-Notification 214 requires an Inward Leakage test rather than a TIL test.

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Disposable surgical masks

    Specifications for filtering face pieces (eg. Surgical, Procedural, Medical Mask)

 

Test

 
Typical Canada/US
ASTM F2100
EN 14683
 
Level 1
Level 2
Level 3
Type IIR
Bacterial Filtration Efficiency, %
≥95
≥98
≥98
≥98
Differential Pressure mm H2O/cm2 (Pa/cm2)
<4.0
<39.2
<5.0
<49.0
<5.0
<49.0
<5.0
Submicron particulate filtration efficiency at 0.1 micron, %
≥95
≥98
≥98
Not Required
Splash Resistance/Synthetic Blood Resistance, mmHg
80
120
160
120
(16.0kPa)
Flame Spread
Class 1
Class 1
Class 1
N/A

    Vendors/manufacturers of “Surgical masks with Visors” should comply to the following specifications:

Surgical Mask
Visors
Hazard Corrected
Prevention of large droplet aerosols and splashes coming into contact with the mucous membranes of the mouth and nose
Prevention of large droplet aerosols and splashes coming into contact with the mucous membranes of the eyes
Safety Features
BFE filtration ≥95%
High level of protection against infection
Shield entire face and extends to both sides of face
Easily removable in case of accidents
Material
Woven inner layer
Polycarbonate
Design
Shingle pleat
Clear
Reusable
No
Fluid Resistant
Yes
Yes
Standard
Meets ASTM F2100 or EN 14683 Type IIR
Meets CSA Z94.3
Medical Device Classification
Yes
Level : 1

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Nitrile gloves / Vinyl gloves

Vendors/manufacturers of gloves (ex. nitrile gloves, vinyl gloves) should submit via the COVID-19 form.

Please refer to the Specifications on gloves.

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Gowns and coveralls

    Specifications for surgical and medical gowns, and coveralls

    Vendors/manufacturers should be ready, upon request, to specify:

  • the level or class that the gowns or coverall are classified to
  • the methods of evaluation used to classify the products
  • the level of risk (Low Risk and High Risk) as identified below

 

North American Standards

European equivalencies

 

CSA Z314 (Canada) and ANSI PB70 (USA)

EN 13795, for Gowns

EN 14126, for Coveralls

Classification

Standard / Testing

Classification

Standard / Testing

Classification

Standard / Testing

Low Risk

Level 1

Minimal water resistance  (some resistance to water spray)

AATCC 42 - Water penetration ≤ 4.5 g

AATCC 127 - Hydrostatic pressure N/A

 

Standard Performance

EN 20811 – Hydrostatic pressure

• Less critical areas ≥ 10cm

• Critical areas ≥ 20cm

Class 1

ISO 16603 (Blood) & 16604 (Viral):  No penetration at 0 kPa

Class 2

ISO 16603 (Blood) & 16604 (Viral): 

No penetration at 1.75 kPa

Level 2

Low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)

AATCC 42 - Water penetration ≤ 1.0 g

AATCC 127 - Hydrostatic pressure ≥ 20cm water column

 

Class 3

ISO 16603 (Blood) & 16604 (Viral): 

No penetration at 3.5 kPa

Class 4

 

ISO 16603 (Blood) & 16604 (Viral):

No penetration at 7 kPa

High Risk

 

Level 3

Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)

AATCC 42 - Water penetration ≤ 1.0 g

AATCC 127 - Hydrostatic pressure ≥ 50cm water column

 

High Performance

EN 20811 – Hydrostatic pressure

• Less critical areas ≥ 10cm

• Critical areas ≥ 20cm

Class 5

ISO 16603 (Blood) & 16604 (Viral):  No penetration at 14 kPa

Level 4

Blood and viral penetration resistance (2 psi)

ASTM F1670 (Blood) & F1671 (Viral):

No penetration at 2 psi (13.8 kPa)

 

 

Class 6

 

ISO 16603 (Blood) & 16604 (Viral):  No penetration at 20 kPa

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Eye protection

Vendors/manufacturers of goggles or face shields should submit via the COVID-19 form.

For specifications for safety goggles and face shields, please refer to the Specifications for eye protection.

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Hand sanitizer

Alcohol-based hand sanitizer could kill bacteria and viruses by denaturing the protective outer proteins of microbes and dissolving their membranes. Proper concentration of these alcohols are effective against killing germs and protecting the skin of those who apply it.

Vendors/manufacturers are required to provide bottles of hand sanitizer. The recommended quantity ranges form 100mL to 2L per bottle. These bottles should have a dispensing system such as:

  • Pump
  • Squeeze bottle
  • Nozzle spray
  • Pouring mechanism

The hand sanitizers must contain one of these approved active medicinal ingredients:

Common name Source material Quantity Product form
Alcohol Ethanol 60 - 80% Liquid
Anhydrous alcohol Ethanol 60 - 80% Gel, solution, spray foam, liquid
Ethanol Ethanol 60 - 80% Gel, solution, spray, foam, liquid, aerosol
Ethyl alcohol Ethanol 60 - 80% Liquid
Grain alcohol Ethanol 60 - 80% Gel, solution, spray, foam, liquid, tincture
Isopropanol Isopropanol 60 - 75% Liquid, pad
Isopropryl alcohol Isopropanol 60 - 75% Gel, solution, liquid, tincture, swab

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ICU-level Ventilators / Ventilators

Vendors/manufacturers for various types of ventilators (ICU-level ventilators, transport ventilators, etc.) should submit via the COVID-19 form.

Please take note of the following specifications documents:

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Thermometers

For use in a hospital setting, oral and rectal thermometers are preferred as they provide the most accuracy. Digital thermometers require probe covers to be included for effective disinfection and avoiding cross-contamination. Thermometer probe covers are required for single-patient use digital thermometers. Non-digital thermometers are single-use and disposable.

The thermometers should contain the below specifications:

Characteristic Specification
Reusable Yes
Range 35 – 43°C
Accuracy ± 0.1°C
Reading time 4 – 14 seconds
Portable Yes
Battery or Plug into 110Vac Yes
Auto on/off Yes
Disposable Sterile Covers Yes
Easy removable sterile covers Yes
Oral Yes
Memory Recall of last reading Yes
Latex Free Yes
Waterproof Yes
Cord Length >3’

The thermometers should fall under one of these categories:

  1. Reusable digital thermometer for oral or rectal use
  2. These thermometers are usually equipped with a cord and are designed to increase productivity and patient safety. The removable/interchangeable oral and rectal probes and probe wells are intended to help you reduce the risk of cross contamination. These are the most recommended for hospital use.
  3. Digital thermometers for ear use
  4. These thermometers measure the temperature inside of the ear by reading the infrared heat. Ear thermometers require probe covers to reduce the risk of cross contamination between individuals. Infrared thermometers are usually used at ports of entry and in quarantine zones.
  5. Digital thermometers for oral or rectal use
  6. These thermometers are mostly used in testing sites and quarantine zones to remove any chance of cross-contamination. Probe covers to be purchased for digital thermometers. Oral and rectal thermometers are differentiated by blue for oral and red for rectal.

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