![]() The standard specifies a test method for evaluating the bacterial filtration effectiveness of medical face mask materials. Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus Synthetic Blood Penetration Resistance (minimum pressure in mm Hg for pass result)īacterial Filtration Efficiency ASTM F2101 The specific requirements of ASTM F2100 level 1, level 2, and level 3 are shown in the following table. Synthetic Blood Penetration Resistance ASTM F1862/F1862M.Particulate Filtration Efficiency ASTM F2299/F2299M.Bacterial Filtration Efficiency ASTM F2101.For example, medical N95 masks need to meet both the Surgical Masks-Premarket Notification Submissions Guidance for Industry and FDA Staff standards, as well as the NIOSH requirements for N95 masks, which require testing for Synthetic blood penetration and surface moisture resistance.įor ASTM F2100 level 1, level 2, and level 3 masks, the ASTM F2100 standard specifies the test methods for mask performance. The main difference between ASTM F2100 level 2 masks and level 3 masks is that level 3 (high protection standard) has higher requirements for synthetic blood penetration resistance. ASTM F2100 level 2 and level 3 require masks that block at least 98% of bacteria and particles, with a differential pressure of just under 6.0mm H 2O/cm 2 (49.03 Pa/cm 2), which is a little more lenient than the lower protection level, because it is harder to maintain breathability while achieving better protection. FDA mask certification basically follows the ASTM F2100 standard.įDA mask certification requires the ASTM F2100 level 1, 2, and 3 surgical masks to meet relevant standards in four areas: bacterial filtration efficiency (BFE), particle filtration efficiency (PFE), and synthetic blood penetration resistance, and differential pressure.ĪSTM F2100 level 1 mask can block 95% of bacteria and particles, even if only ASTM F2100 level 1 protection is achieved, it is sufficient for general protection. government in the Department of PHS (Public Health Service) under the DHHS (Department of Health and Human Services). FDA is the abbreviation of Food and Drug Administration, one of the executive agencies of the U.S. What are the performa nce require ments for ASTM F2100 level 1, level 2, and level 3 surgical masks?ĪSTM F2100 is the current standard for medical masks in the U.S. Protective clothing worn by medical personnel is used for similar purposes as masks and can effectively protect health care workers and patients from the accidental spread of disease. protective clothing and maskĬompared to non-level masks such as homemade cotton masks, the ASTM F2100 level 1, level 2, and level 3 masks will provide better protection against aerosols emitted by the wearer, thereby reducing the spread of disease. The higher the risk, the higher the level of protection mask should be chosen. Wearing a surgical mask of ASTM F2100 level 1, level 2, and level 3 not only prevents the spread of bacteria to the patient through the mouth and nose but also protects you from infection. The higher the level, the better the protection performance.ĪSTM F2100 level 1 and level 2 masks are usually called procedure masks while ASTM F2100 level 3 masks can be used in the operating room and are also called surgical masks. The ASTM F2100 standard is a medical standard that classifies masks into three levels: low protection (Level 1), medium protection (Level 2), and high protection (Level 3). What is a surgical mask of the ASTM F2100 level 1, level 2, and level 3? How to use different levels of surgical masks of ASTM F2100 level 1, level 2, and level 3?.What are the performance requirements for ASTM F2100 level 1, level 2, and level 3 surgical masks?.What is a surgical mask for the ASTM F2100 level 1, level 2, and level 3?.When we buy surgical masks of ASTM F2100 level 1, 2, or 3, do you notice the words of the executive standard on them? A safe and qualified surgical mask product must have an executive standard, and today we bring you the relevant content of the surgical mask of ASTM F2100 level 1, level 2, and level 3. Appendix: General Knowledge of Textiles.Fineness / Thickness / Length / Density / Twist.
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