We would like to thank Primed for the comprehensive questions and answers below regarding medical earloop masks.
What is ASTM?
ASTM refers to the American Society of Testing and Materials American Society of Testing and Materials (ASTM). ASTM is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services—including those in healthcare.
What are ASTM standards for medical face masks?
ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. ASTM F2100 specifies the performance requirements for Medical Face Masks with five basic criteria:
1. BFE (Bacterial Filtration Efficiency):
BFE measures how well the medical face mask filters out bacteria when challenged with a bacteria-containing aerosol.
ASTM specifies testing with a droplet size of 3.0 microns containing Staph. Aureus (average size 0.6-0.8 microns).
In order to be called a medical/surgical mask, a minimum 95% filtration rate is required. Moderate and high protection masks must have bacterial filtration rates greater than 98%.
Some manufacturers use the Modified Greene & Vesley method to determine the BFE rating. This method is NOT recommended by ASTM for product comparison or evaluating consistency.
3. Fluid Resistance:
Fluid resistance reflects the surgical mask’s ability to minimize the amount of fluid that could transfer from the outer layers through to the inner layer as the result of a splash or spray.
ASTM specifies testing with synthetic blood at pressures of 80, 120, or 160 mm Hg to qualify for low, medium, or high fluid resistance.
These pressures correlate to blood pressure: 80 mm Hg = venous pressure (Level 1), 120 mm Hg = arterial pressure (Level 2), and 160 mm Hg (Level 3) correlates to potential high pressures that may occur during trauma, or surgeries that include high pressure irrigation such as orthopedic procedures.
2. PFE (Particulate Filtration Efficiency):
PFE measures how well a hospital mask filters sub-micron particles with the expectation that viruses will be filtered in a similar manner. The higher the percentage, the better the mask filtration.
Although testing is available using a particle size from 0.1 to 5.0 microns, ASTM F2100 specifies that a particle size of 0.1 micron be used.
When comparing test results it is important to note the size of the test particles used, as use of a larger particle size will produce a misleading PFE rating.
4. Delta P (Pressure Differential):
Delta P measures the air flow resistance of the medical mask and is an objective measure of breathability. The Delta P is measured in units of mm H2O/cm2 and the lower the value the more breathable the mask feels.
The ASTM standard requires that masks have a Delta P of less than 6.0 for moderate and high barrier masks, whereas low barrier masks must have a Delta P of less than 5.0.
5. Flame Spread:
As hospitals contain sources of oxygen, heat, and fuel the ASTM standards include testing for flame resistance.
Testing dictates that all hospital masks must withstand exposure to a burning flame (within a specified distance) for three seconds. All PRIMED masks meet this requirement.
5.5 ISO Certification:
In addition to the above tests, all medical face masks must be tested to an international standard (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests to ensure that no materials are harmful to the wearer. Tests are conducted on materials used in construction of the mask which come in contact with the user's skin.
Are there different levels of protection with ASTM-rated medical masks?
Yes, there are three unique levels of protection with ASTM-rated medical masks.
Level 1 masks have the lowest barrier of protection, while Level 3 masks have the highest barrier of protection. For greater clarity on the differences, refer to the information below:
ASTM PROTECTION VS. INTENDED USAGE
LEVEL 1 (LOW) BARRIER MASKS:
80 mm Hg
- Light / minimum BFE & PFE protection
- Used for general procedures and respiratory etiquette
- Designed to resist a splash or spray at venous pressure
LEVEL 2 (MODERATE) BARRIER:
120 mm Hg
- High BFE & PFE protection
- More breathable than high barrier mask
- Designed to resist a splash or spray at arterial pressure
LEVEL 3 (HIGH) BARRIER MASKS:
160 mm Hg
- High BFE & PFE protection
- Highest fluid resistance – designed to resist a splash or spray during tasks like orthopedic surgery or trauma