EN 14683 provides for the construction, design, performance requirements and test methods of medical masks with the aim of limiting the transmission of infectious diseases from staff to patients during surgical procedures and in other medical Settings with similar requirements. Surgical masks with certain microbiological barriers can also effectively reduce the transmission of bacteria and viruses from the nose and mouth in asymptomatic or clinically symptomatic patients.

Standard:

1. Material and structure requirements

A medical mask is a medical device that usually consists of a filter layer placed, bonded or molded between layers of fabric.The medical mask shall not split or tear during its intended use.When selecting filters and filter layer materials, cleanliness (no particulate matter) should be taken into account.

2. Design requirements:

A medical mask shall have a medical device that can be tightly attached to the wearer's nose, mouth and chin, and shall ensure that the mask is tightly attached to the sides.

Medical masks may have different shapes and structures, as well as other functions, such as masks with or without anti-fog features (to protect the wearer from splashing and water droplets) or the outline of the bridge of the nose (to enhance the fit by keeping it in alignment with the nose).

3. Performance requirements:

General requirements

If asepsis is applicable, all tests shall be carried out on the finished product or samples cut from the finished product.

4. Bacterial filtration efficiency (BFE)

Type1 Type2 98 or 95 or higher

5. Microbial cleanliness (biological load)

When tested in accordance with EN ISO 11737-1, the biological load of the medical mask should be ≤30 cfu/g (see Table 1).

Note: EN ISO 11737-1 specifies requirements and provides guidelines for enumeration and microbial characterization of live microbial populations on or within medical devices, components, raw materials, or packages.

Category I medical masks should be applied only to patients and others to reduce the risk of infection transmission, especially in epidemic or pandemic situations.

Class I masks are not intended for use by healthcare workers in operating rooms or other medical Settings with similar requirements.