ASTM F2100: The ASTM F2100 standard is an American standard that specifies requirements and test methods for medical face masks. The standard defines three levels of masks based on their performance in terms of bacterial filtration efficiency, differential pressure, and sub-micron particulate filtration efficiency. The standard also sets requirements for the materials used in the masks, their design and construction, and their labeling and packaging. Compliance with the ASTM F2100 standard is important for ensuring the quality and effectiveness of medical face masks in protecting against the spread of infectious diseases in the United States.
EN14683: The EN14683 standard is a European standard that specifies requirements and test methods for medical face masks. The standard defines several types of masks, including Type I, Type II, and Type IIR, based on their effectiveness at filtering bacteria and other particles. The standard also sets requirements for the materials used in the masks, their design and construction, and their labeling and packaging. Compliance with the EN14683 standard is important for ensuring the quality and effectiveness of medical face masks in protecting against the spread of infectious diseases in Europe.
Both the EN14683 and ASTM F2100 standards specify requirements and test methods for medical face masks. However, there are some differences between the two standards.
- Performance criteria: The EN14683 standard defines several types of masks, including Type I, Type II, and Type IIR, based on their effectiveness at filtering bacteria and other particles. In contrast, the ASTM F2100 standard defines three levels of masks based on their performance in terms of bacterial filtration efficiency, differential pressure, and sub-micron particulate filtration efficiency.
- Test methods: The test methods used in the two standards differ somewhat. For example, the EN14683 standard specifies a bacterial filtration efficiency test using Staphylococcus aureus bacteria, while the ASTM F2100 standard specifies a similar test using a different bacterium, namely, the Bacteriophage phiX174.
- Requirements for materials: The requirements for materials used in the masks differ between the two standards. For example, the EN14683 standard requires that the mask’s filter material be made of at least three layers of non-woven material, while the ASTM F2100 standard specifies the use of specific materials and the number of layers required.
- Labeling and marking: The labeling and marking requirements for the two standards are also different. The EN14683 standard requires that masks be marked with certain information, such as the type of mask, the manufacturer’s name and address, and the date of manufacture. The ASTM F2100 standard requires similar information, as well as a specific code indicating the mask’s level of performance.
In summary, both standards are designed to ensure the quality and effectiveness of medical face masks, but they differ in terms of their performance criteria, test methods, requirements for materials, and labeling and marking requirements. It’s important to note that the standards are intended for different regions – EN14683 is a European standard, while ASTM F2100 is an American standard – and compliance with the appropriate standard depends on where the masks will be sold or used.