Type IIR medical masks are recommended for healthcare personnel, patients and all other people, to reduce the risk of spread of infection, in the context of the COVID-19 pandemic.
DOMAIN D 'APPLICATION
A Type IIR mask for medical use, corresponding to standard EN 14683, thus presenting an appropriate antimicrobial barrier, it proves effective in reducing the emission of infectious agents coming from the nose and mouth of a patient or a person presenting clinical or asymptomatic symptoms, particularly in the context of an epidemic or pandemic, such as for COVID-19.
The EN 14683 standard specifies the manufacturing, design and performance requirements, as well as test methods for masks for medical use intended to limit the transmission of infectious agents from members of the medical team to patients during surgical and other procedures medical procedures with similar requirements.
CLASSIFICATION
Masks for medical use specified in the European Standard are classified into two types (I and II) according to the bacterial filtration efficiency (BFE), after which a Additional subdivision is made for type II depending on whether or not it is splash resistant. The letter “R" designates splash resistance. The Type IIR mask is recommended in the context of the COVID-19 pandemic because it is more protective than Type I.
DESIGN
The mask for medical use must be made so that it can fit closely over the nose, mouth and chin of the person wearing it and allow perfect seal on the sides.
REQUIREMENTS / MATERIALS AND MANUFACTURING
The mask for medical use is a medical device, usually composed of a filter layer positioned, glued or molded between layers of non-woven fabric. It must not decompose, separate or tear during intended use.
BACTERIAL FILTRATION EFFICIENCY (EFB)
EFB determines the effectiveness of the materials constituting the mask for medical use as a barrier against bacterial penetration. When tested in accordance with the indications, the effectiveness of bacterial filtration (EFB) of the mask for medical use must comply with a minimum value specified in the standard for the corresponding type.
For thick and rigid masks such as rigid duckbill or shell-shaped masks, the test method may not be suitable. In this case the test method is determined by the standard EN 149:2001 + A1:2009 for Respiratory Protective Devices which defines the types of masks in FFP1, FFP2, FFP3.
