By Brandon Williams, Study Director of Protective Barriers
Have you ever wondered what the differences are between surgical masks and respirators and how and when they should be used? You are not alone. The basic answer is surgical masks, for the most part, are worn to prevent particles coming out of the mouth of the wearer from coming in contact with others. Respirators on the other hand are a tight fit and are used to protect the wearer from harmful particles coming in contact with them.
For surgical masks, there are five different tests the FDA recognizes that are found in the ASTM F2100 standard – Bacterial Filtration Efficiency (BFE), Differential Pressure, Sub-micron Particle Filtration Efficiency (PFE), Synthetic Blood Penetration and flammability. Based on the performance of the face mask material manufacturers can classify them as Level 1-3. All surgical mask testing can be conducted at Nelson Laboratories.
Respirators are tested using either sodium chloride or dioctyl phthalate particles to challenge the full respirator for filtration efficiency. Breathability is also performed as well as valve leakage if an exhalation valve is present. Testing follows the procedures outlined by NIOSH (National Institute of Occupational Safety and Health), which are based on the guidelines set forth in the Code of Federal Regulation (CFR), 42 CFR Part 84.Because the respirator is intended to protect the wearer, fit testing is performed to show there will be a tight seal.
NIOSH testing is considered “worst-case” as the testing conditions are the most severe likely to be encountered in a work environment. Samples must be submitted to NIOSH for certification, but before they do manufacturers must have data showing that they have passed a pre-qualification test following the procedure listed in 42 CFR Part 84. All pre-qualification testing can be conducted at Nelson Laboratories for N95 and N99 respirators.
A respirator can also be labeled as a surgical mask. When doing this manufacturers can substitute the filtration efficiency and breathability testing listed in ASTM F2100 with their NIOSH certificate, according to FDA guidance.
Manufacturers need to define how the masks will be used to determine the proper test and usage of each mask. Manufacturers can contact Nelson Laboratories for additional information and help on determining the right test for each of the different types of masks.