What are the characteristics of medical masks?
Medical Face Mask: A medical device that covers the mouth and nose to provide a barrier that minimizes the direct transmission of infectious microorganisms between personnel and patients. A medical face mask must meet the definition of a medical device and therefore should have a medical purpose intended by the manufacturer.
This intended use is typically to limit the transmission of infectious agents from personnel to patients during surgical procedures and other similar medical settings. A medical face mask with an appropriate microbial barrier should also be effective in reducing the spread of infectious agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
Medical face masks should be distinguished from protective face masks or respirators (PPE) that are intended only for a person to protect against one or more risks to their health or safety and do not fall within the definition of a medical device.
Face coverings do not meet the legal definitions of PPE or a medical device as they are not intended for any medical or personal protective purpose by the manufacturer. However, some Member States, standardization organizations, or other bodies may provide guidance on the characteristics and use of these face coverings.
