Understanding Medical Mask Standards

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The first time I bought a mask was when my nephew was only a few months old. He was so little and I had a little bit of a cold, so I didn’t want to pass that along to him. I got the mask from a local pharmacy and when I went to put it on, I couldn’t even figure out which side should be facing out. Flash forward several years and masks have become a part of everyday life. I’ve finally learned how to put one on properly and I’ve learned a lot about the different types of medical standards that masks can abide by. I’m writing this article to help others understand these medical standards so that they can choose the best mask for them. 

Standard Setting Bodies

The first thing we need to cover is the standard setting bodies. Think of these organizations as the same as those who set the rules in hockey. In hockey, they set the rules for icing, for penalties, and how many skaters you can have on the ice. Standard setting bodies such as the American Society for Testing and Materials set the rules for medical masks in North America. This does not mean that they test the masks that are ultimately deemed as medical, they simply make the rules that the masks must follow, and it’s up to the manufacturer and distributor to ensure that these masks abide by the rules laid out.

Health Canada Approved Standards

As the governing body over medical equipment and pharmaceuticals in Canada, Health Canada picks the approved standards that medical masks must abide by in order to be deemed medical. This means that they are choosing the set of rules they need the masks to play by in order to meet their definition of medical. Think of American football vs rugby. They are similar sports with different sets of rules. Relating this back to medical masks, it’s up to Health Canada to review the rules, then to determine which ‘rules’ meet the standards it is looking for. Health Canada will then communicate which rules must be followed in order for the mask to be deemed medical. ,

During the pandemic, Health Canada has released several standards that it has outlined as rigorous and effective enough to be deemed as medical. These standards include ASTM-2100 (the number references the specific set of rules that ASTM has outlined) as well as the European Medical Standard EN14683 Type IIR. Masks that have testing documentation that show alignment with these Health Canada approved standards can be sold and marketed as medical. 

The Standards

Health Canada Specifications for Covid-19 products

What’s the difference?

When you look at the table, the majority of the numbers fall into a similar range. ASTM has 3 levels of increasing bacterial filtering efficiency requirements (BFE) and particulate filtering efficiency requirements (PFE). Level 3 also has an increased requirement for splash resistance because these masks are most typically used in a dental office with increased chance for splashes and sprays in close quarters.

The EN14683 Type IIR standard most closely aligns with ASTM-2100 Type 3, but does not have a ‘rule’ around how good it needs to be at PFE. This simply means that the mask does not need to be tested for PFE in order to pass the test, it does not mean that it has an inferior capability to filter particles.

During the pandemic, Health Canada has released several standards that it has outlined as rigorous and effective enough to be deemed as medical. These standards include ASTM-2100 (the number references the specific set of rules that ASTM has outlined) as well as the European Medical Standard EN14683 Type IIR. Masks that have testing documentation that show alignment with these Health Canada approved standards can be sold and marketed as medical. 

What standard do First Defence Canadian Made Medical Face Masks meet?

First Defence Medical Masks are tested to and comply with the ASTM-2100 Level 3 Standard. This means that the medical masks available through our e-commerce store abide by a medical standard that is approved by Health Canada. First Defence Face Masks hold a Medical Device Establishment Licence which is a Health Canada issued credential that authorizes us to distribute medical-grade products. This means that when you shop for medical masks with First Defence, you know you’re getting a mask that aligns with a Health Canada approved standard, and is of the highest-quality. See below for a summary of our testing results:

Test  ASTM 2100 Level 3 First Defence Medical Face Mask
Bacterial Filtration Efficiency, % ≥98 99.9+
Differential Pressure, Pa/cm2 <49.0 Pass
Submicron particulate filtration efficiency at 0.1 micron, % ≥98 98+
Splash Resistance/Synthetic Blood Resistance, mmHg 160 Pass
Flame Spread Class I Class I

What standard do First Defence Imported Medical Face Masks meet?

First Defence Medical Masks are tested to and comply with the EN14683 Type IIR. This means that the medical masks available through our e-commerce store abide by a medical standard that is approved by Health Canada. First Defence Face Masks hold a Medical Device Establishment Licence which is a Health Canada issued credential that authorizes us to distribute medical-grade products. This means that when you shop for medical masks with First Defence, you know you’re getting a mask that aligns with a Health Canada approved standard, and is of the highest-quality. See below for a summary of our testing results:

Test  EN 14683 Type IIR First Defence Medical Face Mask
Bacterial Filtration Efficiency, % ≥98 99.7
Differential Pressure, Pa/cm2 <60.0 33.0
Submicron particulate filtration efficiency at 0.1 micron, % N/A N/A
Splash Resistance/Synthetic Blood Resistance, mmHg 16.0kPa >16.0
Flame Spread N/A N/A

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