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

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