Medical mouth and nose protection masks, surgical masks
Medical face masks (MNS; surgical (surgical) masks) are developed for external protection and protect the counterpart from exposure to infectious droplets of the person wearing the face mask. Corresponding medical face masks, however, also protect the wearer of the mask when they are firmly in place, even if this is not the primary purpose of the masks. They are used, for example, to prevent droplets from the breath of the treating person from getting into the patient's open wounds.
Since the wearer not only inhales through the filter fleece, depending on the position of the medical face mask, but the breathable air is sucked in past the edges of the MNS as a leakage current, medical face masks usually offer little protection against aerosols containing pathogens. However, you can protect the mouth and nose area of the wearer from direct impact of expired droplets from the other person and from the transmission of pathogens through direct contact with possibly contaminated hands.
Medical face masks are on the market as medical products and are therefore subject to medical product law.
Non-sterile medical face masks are generally medical devices of risk class I according to the Medical Device Directive (93/42 / EEC, MDD) and must meet the DIN EN 14683: 2019-10 standard. After a successful verification procedure (conformity assessment procedure), manufacturers can provide them with the CE mark and they are then freely marketable in Europe.
The KELA MNS-MedPRO surgical mask has been tested in the laboratory and meets the test procedures for a type IIR mask according to DIN EN 14683: 2019.
|Examination / test / target values||Type IIR||MNS-MedPRO|
|Bacterial filter performance [%]||≥ 98||99,88|
|Pressure difference [Pa / cm²]||<60||45|
|Microbiological purity [CFU / g]||≤ 30||8|
|Pressure of the spray resistance [kPA]||≥ 16.0||Fulfills|
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