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It is an accepted standard specification meant to test the performance of medical face mask materials. The standard is developed on five important performance metrics: bacterial filtration efficiency (BFE), particulate filtration efficiency (PFE), differential pressure (breathability), synthetic blood resistance, and flammability. Based on their performance in these standards, medical face masks are categorized into three levels: Level 1 (low barrier protection), Level 2 (moderate barrier protection), and Level 3 (high barrier protection). This categorization helps to match the masks to their respective clinical application, whether for routine procedures, moderate fluid exposure, or high-risk surgery.
| Bacterial Filtration Efficiency (BFE) | Conducted using aerosolized Staphylococcus aureus to measure the percentage of bacteria filtered by the mask. |
| Particulate Filtration Efficiency (PFE) | Measures the mask’s ability to filter sub-micron particles (typically 0.1 µm) using polystyrene latex spheres. |
| Synthetic Blood Resistance | Involves projecting synthetic blood at a specific velocity to evaluate penetration resistance of mask material. |
| Aerosol generator and collection apparatus | Mask samples are cut to standard sizes and sealed in holders for accurate measurement in aerosol test chambers. |
| Particle counter and test chamber | Samples are mounted securely with no air leakage and conditioned at controlled temperature and humidity levels. |
| Blood penetration apparatus | Samples are placed on holders at a set distance, ensuring the surface is flat and free of visible defects. |
Test results decide the protection level of the mask. A mask requiring BFE and PFE of 95% or more and lower differential pressure meets Level 1. Level 2 masks are required to show BFE and PFE of 98% or more, moderate fluid resistance, and acceptable breathability. Level 3 masks show the maximum filtration efficiency (≥98%) and maximum resistance against penetration by synthetic blood. Flammability is also tested, with all medical masks having to pass Class 1 requirements, meaning that they burn slowly or extinguish themselves, minimizing fire risks in medical settings. The overall interpretation of these findings guarantees that healthcare workers can rely on the performance of the product in actual situations.
| Service Name | Remarks |
|---|---|
| ASTM F2100 Testing | Contact US |
Standards supplementing ASTM F2100 include ASTM F1862, prescribing procedures for measuring the synthetic blood penetration resistance of medical masks. ASTM F2299, standardizing for measurement of particle filtration efficiency, is another supplementary standard. Journal publications from agencies such as the CDC and WHO further provide guidance for the use and performance criteria for masks in hospital environments, extending insight into the applicability of ASTM F2100.
ASTM F2100 is extensively used in the medical field to instruct manufacturers to produce face masks that are suitable for various clinical risk levels. The specification is depended upon by manufacturers to perform tests and classification of products before going to the market. Hospital facilities and medical service providers adopt ASTM F2100 classifications in purchasing masks suited for various procedures. Outside of healthcare settings, the standard is cited by the industry for personal protective equipment, particularly during worldwide health crises when the performance of masks is vital to public health.