Medical grade masks and other items of PPE for use in hospitals and other health settings have been the subject of international standards for many years. The European Union has been producing such standards and it is these that are used in the UK. For example, the standard for 3 Ply surgical face masks is EN14683 which is updated from time to time the current version being EN14683:2019. To obtain certification, masks must be tested by an approved notified body such as the British Standards Institute (BSI).  There are many of these notified bodies throughout Europe, they are not all able to test Medical face masks or PPE equipment.  A list of notified bodies can be found here.

The Coronavirus pandemic has given rise to a huge increase in demand for masks and one of the results of this has been the proliferation of sub-standard masks. These may just not meet the minimum requirements set down by the government or their producers may claim they have a level of certification that they do not. The importance of using PPE of defined and reliable performance has become obvious.

A further development resulting from advice (and legislation) to combat the spread of the virus has been the requirement to wear masks in an increasing number of non-medical contexts – on the bus, in the shop, even in the street in some places. Here, the protection provided by masks may not need to be as high as for medical masks but there has been a proliferation of types of masks including washable and homemade (medical masks are, more often than not, designed for a single-use).

The European Commission became concerned that, although at a lower level, standards should exist for these masks too. Demonstrating the concern, a fast track process has been used to introduce a set of European standards and the results were published in June 2020.  The resulting document is published by the Centre for European Standardisation (CEN) as a “CEN Workshop Agreement” number CWA 17553:2020. The agreement characterises the masks as “community face coverings”. Community face coverings are intended for use by people not displaying any clinical symptoms of viral or bacterial infection and do not come into contact with people displaying such symptoms. The purpose of a community face covering is defined thus, “this community face covering minimises the projection of user’s respiratory droplets saliva, sputum or respiratory secretions when talking, coughing or sneezing. This community face covering may also limit penetration in the user’s area of nose and mouth of the respiratory droplets from external origin without claiming the user protection. It also prevents this user’s area from any contact with the hands.”

The document goes on to list a set of minimum standards for these masks addressing characteristics including,

  • Dimensions
  • Packaging
  • Materials
  • Cleaning
  • Filtration Efficiency
  • Breathing Resistance and Air Permeability

The document also outlines how testing of community masks should be done.

It should be noted that it is not mandatory for masks to conform to this standard. Rather these are minimum recommendations for manufacturers who are attempting to produce a quality product with officially acceptable performance characteristics.

There now, since June 2020, exists a series of minimum standards that manufacturers should use when producing so-called community masks i.e. everyday reusable masks. Although these are not mandatory, they mirror, albeit at a less stringent level, the standards for medical PPE.

Sera Supplies Washable Face Masks meet and surpass these new standards. In fact, when new, they offer equivalent bacterial filtration to a type I disposable medical mask i.e. >95%. After 50 washes at 40°C, they still meet the new standard of >90%

Advice concerning Corona Virus is changing all the time and it is important to get the latest government/medical guidance before deciding which PPE you should be using. For England, guidance can be found here 

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