When it comes to face masks, three categories are distinguished:

  • FFP masks that protect the wearer against (aerosol) particles and thus against, for example, viruses in the air. These masks are subject to the European PPE Regulation for personal protective equipment;
  • Surgical face masks worn by health care staff to protect patients. These masks are subject to the European Medical Devices Regulation;
  • Non-medical face masks that are often made at home (from textiles or paper).

Patient protection

Kiwa focuses its surgical face mask testing services towards manufacturers, importers and buyers. A medical face mask covers a healthcare provider's mouth and nose with textiles (polypropylene or cellulose). As a result, the air that the healthcare practitioner exhales is filtered from micro-organisms, so that the patient is protected. There are also surgical face masks that protect the healthcare provider from blood and other liquid splashes from the patient (Type llR).

EN 14683

The requirements that surgical face masks must meet are described in the European standard EN 14683. This standard describes the requirements within the various application areas with regard to the filtering efficiency of the filter, the breathing resistance, the microbial cleanliness and the splash resistance. Within EN 14683, three types of medical face masks are distinguished: Type I, Type II and Type IIR.

The overview below shows the different types of surgical face masks and the different assessment criteria:

  • Type I masks offer the least protection and are therefore only used in situations with a relatively low risk (i.e. not during operations). - Bacterial filter efficiency (%) ≥ 95% - Breathing resistance (Pa/cm2) <40 - Splash resistance (kPa) n/a
  • Type II masks have a more effective filter and are not splash resistant. - Bacterial filter efficiency (%) ≥ 98% - Breathing resistance (Pa / cm2) <40 - Splash resistance (kPa) n/a
  • Type IIR masks also have a high filter efficiency (at least 98%) and are splash resistant.  - Bacterial filter efficiency (%) ≥ 98% - Breathing resistance (Pa / cm2) <60 - Splash resistance (kPa) ≥ 16.0

EN 14683 testing by Kiwa

For manufacturers and importers of surgical face masks and purchasers of hospitals and other healthcare institutions, Kiwa is the one-stop shop for testing against the standard EN 14683. In collaboration with partner labs, we test the bacterial filter efficiency of the mask, the bacterial growth, breathing resistance and resistance to liquid splashes (according to ISO 22609). By having your face masks tested at Kiwa against EN 14683 as a manufacturer or importer, you can lean on reliable test results. As a purchaser, having (samples of) masks tested by Kiwa you know that you contribute to the safety and quality of the healthcare for your patients.