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Medical Personal Protection Equipment

Overview

Medical Personal Protection Equipment (PPE) Testing and Certification

The ongoing COVID-19 pandemic has resulted in shortages of Personal Protection Equipment (PPE) for frontline workers in hospitals and healthcare facilities. Industry has responded with a rapid expansion of companies manufacturing PPE equipment. The pandemic and explosion of manufacturers highlighted the need for a consistent way to identify that the PPE relied on by the most at-risk workers, meets all relevant safety standards. In response to this need, CSA Group has opened the first laboratory to offer both testing and certification for a range of medical PPE intended for use in Canada. The testing and certification program may help ensure that the medical PPE meets safety, environmental and operating performance standards required for the Canadian market.

Medical PPE Product Types

CSA Group now offers manufacturers both testing and certification of;

  • Medical gloves
  • Medical gowns and drapes
  • Medical masks
  • Respirators
  • Face shields

The testing and certification required varies by the type of PPE. We test and certify medical PPE to CSA, ASTM, AAMI, and CFR standards.

Product type Certification Standards Testing Standards
Medical Gloves ASTM D6319
ASTM D3578
ASTM D5250
ASTM D6977
ASTM D412
ASTM D573
ASTM D3767
ASTM D5151
ASTM D6124
ASTM D5712
Medical Gowns and Drapes AAMI PB70 AATCC 42
AATCC 127
ASTM F1670
ASTM F1671
Medical Mask ASTM F2100 ASTM F2101
ASTM F2299
ASTM F1862
EN 14683, Annex C
16 CFR 1610
Respirators 42 CFR 84 NIOSH Standard Test Procedures (STP)
Face Shields CSA Z94.3
ANSI Z87.1
CSA Z94.3
ANSI Z87.1

Note: All applicable standards are used for both certification and testing of products unless stated otherwise.

Medical PPE Testing

CSA Group tests various medical PPE according to CSA, ASTM, AAMI and CFR standards. We evaluate the characteristics and performance of the medical PPE as outlined below.

Medical PPE Type Material Type Standard Test Type
Gloves
  • Nitrile
  • Rubber
  • Vinyl
  • Polychloroprene
  • ASTM D6319
  • ASTM D3578
  • ASTM D5250
  • ASTM D6977
  • Physical properties
  • Dimensional measurements
  • Residual powder
  • Detection of holes
  • Aqueous extractable protein
Medical Gowns/Drapes
  • AAMI PB70
  • Barrier level performance (Levels 1, 2 and 3)
  • Resistance to blood penetration (Level 4 drapes)
  • Resistance to Penetration by blood-borne pathogens (Level 4 gowns)
Medical Masks
  • ASTM F2100
  • Bacterial filtration efficiency
  • Particulate filtration efficiency
  • Differential pressure
  • Blood penetration
  • Flammability
Respirators
  • With valve
  • Without valve
  • 42 CFR Part 84
  • Filtration efficiency
  • Inhalation/Exhalation
  • Valve leakage
Face Shields
  • CSA Z94.3
  • ANSI Z87.1
Performance requirements against applicable hazards
Medical PPE Certification

CSA group tests various medical PPE according to CSA, ASTM, AAMI and CFR standards. In addition to testing and performance evaluation, as outlined below, factory audits and on-going conformity tests are conducted to help ensure that manufacturers are maintaining a good quality management system that produces products of consistent quality meeting the applicable standards.

Medical PPE Type Material Type Standard Test Type
Gloves
  • Nitrile
  • Rubber
  • Vinyl
  • Polychloroprene
  • ASTM D6319
  • ASTM D3578
  • Physical properties
  • Dimensional measurements
  • Residual powder
  • Detection of holes
  • Aqueous extractable protein
Medical Gowns/Drapes
  • AAMI PB70
  • Barrier level performance (Levels 1, 2 and 3)
  • Resistance to blood penetration (Level 4 drapes)
  • Resistance to Bacteriophage Penetration (Level 4 gowns)
Medical Masks
  • ASTM F2100
  • Bacterial filtration efficiency
  • Particulate filtration efficiency
  • Differential pressure
  • Blood penetration
  • Flammability
Respirators
  • With valve
  • Without valve
  • 42 CFR Part 84
  • 16 CFR 1610
  • ASTM F1862
  • Filtration efficiency
  • Inhalation/Exhalation
  • Valve leakage
Face Shields
  • CSA Z94.3
  • ANSI Z87.1
  • Performance requirements against applicable hazards

Frequently Asked Questions

Medical Personal Protection Equipment FAQ

We have created a helpful FAQ document to help answer the most important questions you might have regarding getting approval for your medical PPE products into the Canadian market.

Resources

For more information on the medical PPE products included in the new certification program visit the links below:

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