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

Gowns and coveralls

Ventilators

Disposable N95 masks

    Specifications for filtering face pieces (eg. NIOSH N-95 Respirator)

Typical
Alternative
Certification/Class Label
NIOSH N-95 (42 CFR Part 84)
CE FFP2 (EN149-2001)
KN95 (GB2626-2006)
Labelling Information on respirator
• Manufacturers Name
• TC-84A-####
NIOSH
• Lot Number
• Filter designation (i.e. N95)
• Model Number
Additional information 1
• 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
• Type and grade of filter elements (i.e KN95)
Additional
• Must be a tight fitting respirator and able to perform a facefit test
• Must have two straps, preferably head straps
Documents vendors/manufacturers should be ready to provide upon request
• Certificate of Compliance issued by the manufacturer stating that the product meets all quality verifications
• Valid EN-149-2001 certificate identifying the product that has be certified
• Certificate of Compliance issued by the manufacturer stating that the product meets all quality verifications
• Valid GB2626-2006 certificate identifying the product that has be certified
• Certificate of Compliance issued by the manufacturer stating that the product meets all quality verifications
• Test data for the KN95 respirator

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

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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

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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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Ventilators

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

Please note that the following specifications are related to ICU-level ventilators only: Specifications for ICU-level ventilators

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