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.
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.
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 |
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Medical Gowns/Drapes |
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Medical Masks |
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Respirators |
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Face Shields |
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Performance requirements against applicable hazards |
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 |
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Medical Gowns/Drapes |
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Medical Masks |
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Respirators |
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Face Shields |
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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.
Request

Resources

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

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