EN 14683 specifies the structure, design, performance requirements and test methods of medical masks. The purpose is to limit the transmission of infectious diseases from staff to patients during surgical procedures and other medical environments with similar requirements. Medical masks with a certain microbial barrier can also effectively reduce the spread of bacteria and viruses from the nose and mouth of asymptomatic patients or patients with clinical symptoms.
Standard
1. Material and structure requirements
A medical mask is a medical device that usually consists of a filter layer placed, glued or molded between fabric layers. During the scheduled period of use, medical masks must not be split or torn. When selecting filters and filter layer materials, attention should be paid to cleanliness (no particles).
2. Design requirements
Medical masks should have medical devices that can be tightly installed on the nose, mouth and chin of the wearer, and ensure that the mask can fit tightly on both sides.
Medical masks may have different shapes and structures, as well as other functions, such as masks with or without anti-fog function (to protect the wearer from splashes and water droplets) or the bridge of the nose (enhanced by keeping fit with the nose) Fit) contour).
3. Performance requirements
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If applicable to aseptic conditions, all tests should be performed on the finished product or samples cut from the finished product.
4. Bacterial filtration efficiency (BFE)
Type1≥95 Type2≥98
5. Microbial cleanliness (bioburden)
When tested in accordance with EN ISO 11737-1, the bioburden of medical masks should be ≤30 cfu/g (see Table 1).
Note: EN ISO 11737-1 specifies the requirements and provides guidelines for enumeration and microbiological characterization of live microbial populations on or in medical devices, components, raw materials or packaging.
