A medical face mask, as the surgical mask is precisely called, is a medical device of risk class I according to the Medical Devices Regulation VO (EU) 2017/745. The European technical standard EN 14683 defines which requirements such a mask must fulfil.

Background

The transmission of infectious germs during surgical interventions can occur in several ways. One source of infection is, for example, the nose or the mouth of a member of the surgical team. Medical masks are primarily used to prevent the transmission of infectious germs from germs from staff to patients in operating theatres and other medical medical facilities. However, in certain situations they also protect against splashes of potentially contaminated or infectious (body) fluids. In addition, they can be worn by patients and others to reduce the risk of spreading infections. spread of infection, especially in epidemic or pandemic situations. epidemic or pandemic situations.

Scope of application

European standard EN 14683 addresses construction and design, performance requirements and test methods for medical face masks. A medical face mask with an appropriate microbiological barrier can also be used for the reduction of infectious infectious germ secretions from the mouth and nose of an asymptomatic or asymptomatic wearer or a patient with clinical symptoms.

Classification

Medical face masks are classified according to various criteria into into three types (Type I and Type II), with Type II being further categorised whether or not the mask is fluid resistant (Type II or Type IIR). (Type II or Type IIR).

The standard also regulates how high the germ load of the still unused product may be. This ensures that the mask does not pose a microbial microbial hazard to the wearer or the patient.

Performance requirements

* Type IIR is a fluid resistant type. | ** Type I medical face masks should only be used on patients and other individuals to reduce the risk of spreading spread of infection, particularly in epidemic or pandemic situations. situations. Type I masks are not intended for healthcare professionals in operating rooms or in other medical medical facilities with similar requirements.

Labelling

The Medical Devices Regulation (EU) 2017/745 specifies the information that must be provided on the packaging in which the medical face mask is supplied:

1. CE marking in conformity with the directive
2. Product name
3. Number of this European Standard
4. Type of mask (according to the information in the table above)
5. Address of the manufacturer