Surgical Masks

REQUIREMENTS AND TEST METHODS SPECIFIED BY THE EUROPEAN NORM EN 14683:2005 (IN ITALY, UNI EN 14683:2006)

Foreword

It is now in force the European norm EN 14683:2005, which specifies the production and performance requirements and the test methods for the surgical masks intended to limit the transmission of infective agents between patients and staff during the surgical operations.

Introduction

The transmission of infective agents during surgical procedures in operating theatres and other medical settings can occur in several ways. Sources are, for example, noses and mouths of the surgical team. The main intended use of the surgical masks is to protect the patients from infective agents coming from the noses and mouths of the staff and, in certain situations, additionally to protect the wearer against splashes of potentially contaminated liquids.

Scope

The European norm EN 14683:2005 specifies construction, performance requirements and test methods for the surgical masks intended to limit the transmission of infective agents from the staff to patients and (vice-versa in certain situations) during surgical procedures in operating theatres and other medical settings with similar requirements.

This European Standard is not applicable to masks intended exclusively for the personal protection of the staff.

A special case, also covered by the European Medical Device legislation, is that in which the wearer wishes to protect him/herself against splashes of potentially contaminated fluids. For this application, this European Standard specifies performance requirements and gives a test method for a special class of surgical masks offering protection against splashes.

Classification

Surgical masks specified in this European Standard are classified into two types according to bacterial filtration efficiency and differential pressure, and each type is further divided according to whether or not the masks are splash resistant.

Terms and definitions

Surgical mask :

Medical device covering the mouth, nose and chin providing a barrier to minimise the direct transmission of infective agents between staff and patient.

Bacterial filtration efficiency (BFE):

Effectiveness of a surgical mask in capturing aerosol droplets containing bacteria.

Differential pressure:

Pressure drop across a surgical mask under specific conditions of air flow, temperature and humidity