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Testing of Face Masks to ASTM D5035 / ISO 16900 and Other Test Standards

There is a wide variety of face masks. These range from basic mouth and nose protection to masks with filter elements for protection against small particles to class FFP1, FFP2 or FFP3. 

Surgical face masks are intended to protect patients. As class I medical devices they are subject to the requirements of the Medical Devices Regulation 2017/745. Particle filtering respirator masks are intended to protect the wearer from particles, and as personal protective equipment (PPE) of the highest category 3, they are subject to Regulation 2016/425 on personal protective equipment.

    Related standards to testing of face masks

    The specific requirements for mechanical tests are described in different ASTM, ISO and EN standards, including:

    • DIN EN 14683: 2019-10 – Medical face masks – Requirements and test methods
    • DIN EN 149: 2009-08 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking
    • ASTM D5035 - 09 (Reapproved 2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Strip Method) 

    Determination of the volume flow index (MVR)

    Polypropylene (PP) serves as a raw material, which is spun and meltblown for use in face masks. While the spun form has a low melt flow index, the melt flow index of the meltblown form is three times as high. ZwickRoell’s Mflow can process both materials and delivers accurate and reliable results. 

    Determination of the breaking strength and elongation of face masks to ASTM D5035

    In addition to penetration resistance, breaking strength and elongation are important factors in product quality. Breaking strength and elongation are tested according to ASTM D5035. Exact specimen preparation, as well as correct gripping and retightening of the specimen grips are essential for reliable test results. 

    Determination of the tensile force between mask band and mask body

    The connection between the mask band and mask body is a deciding factor for reliable and comfortable use of a face mask, especially over an extended period of time. With a tensile test in accordance to ASTM D5034, the axial tensile force can be determined. 

    Tensile test on the exhalation valve housing to DIN EN 149

    The previous test applications apply to both surgical face masks and PPE respirator masks. Testing to DIN EN 149, on the other hand only applies to PPE respirator masks. If they include one or more exhalation valves and the housing is attached to the mask body, a tensile test is required. The housing must withstand an axial acting force of 10 N for a period of 10 seconds.

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