Sterile and non-sterile face masks

Sterile and non-sterile face masks

Face masks can be either sterile or non-sterile. If it is a sterile face mask, a four-digit code must be placed below or after the CE mark. The four-digit code is used to identify the independent certification company having supervised the sterilisation process. Therefore, if it is not a sterile face mask, there is no requirement for a four-digit code on the product’s packaging.

The applicable international standard for medical (surgical) face masks is:

EN 14683:2019+AC:2019, which was issued on 12 August 2019 and therefore applies to all medical face masks of Type I, Type II and Type IIR manufactured after this date. This date does not have to appear from the packaging.