Technical specifications for pre-market assessment of medical masks

The purpose of this document is to provide technical specifications to medical mask manufacturers. The document is intended mainly for manufacturers but could also be used as a reference by regulators.

The manufacturer should consider the technical specifications outlined as minimum requirements in order to ensure that the medical mask has been designed, evaluated, and validated in conformity with those requirements and is therefore safe and effective. The manufacturer shall provide evidence of the safety and performance of the medical mask to demonstrate that it performs as intended and as declared in the indications for use.