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 single use respirators
Disposable surgical masks
Nitrile gloves / Vinyl gloves
Gowns and coveralls
Eye protection
Hand sanitizer
ICU-level Ventilators / Ventilators
Thermometers
Disposable single use respirators
Note: Canadian manufacturers should refer to Health Canada’s guidance on safety and performance requirements in the absence of a Canadian national standard
Specifications for filtering face pieces (NIOSH N95 and alternatives):
|
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
|
|
|
|
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
|
|
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
|
Medical Protective Mask 95% Efficiency (GB 19083-2010)
|
KN95 (GB2626-2006)
|
|
|---|---|---|
|
Labelling Information on respirator
|
|
|
|
Nasal splints
|
Must be adjustable
|
N/A
|
|
Mask Harness
|
|
|
|
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)
|
|
N/A
|
|
Biological Filtration Efficency
|
N/A
|
N/A
|
|
TIL (total inward leakage)
|
N/A
|
|
|
Exhalation valve leakage requirement
|
-
|
Depressurization to 0 Pa ≥ 20 sec
|
|
Force applied
|
-
|
-1180 Pa
|
|
CO2 clearance
|
N/A
|
≤ 1%
|
|
CE FFP2 (EN149-2001)
|
P2 (AS/NZ 1716:2012)
|
Korea 1
|
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 1
|
• 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.
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)
|
<5.0
|
<6.0
|
<6.0
|
<5.0
<49.0
|
|
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
|
Microbial Cleanliness (cfu/g)
|
N/A
|
N/A
|
N/A
|
<30
|
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
|
|
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.
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 13795-1, 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 |
ISO 811 – 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 |
ISO 811 – 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 |
|||
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.
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 |
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:
- Specifications for ICU-level ventilators
- Specifications for ventilators (scaled-down requirements)
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:
- Reusable digital thermometer for oral or rectal use
- Digital thermometers for ear use
- Digital thermometers for oral or rectal use