Standardization of infection protection masks

A new standard for masks is being developed at European level. It is to contain test procedures for protection of the wearer and other persons against airborne pathogens.

Since the outbreak of the pandemic, wearing masks whilst shopping, on public transport and at work has become the norm. FFP2 masks and surgical masks have primarily been used, and continue to be used, for protection against infection with COVID-19 by airborne particles, i.e. via the respiratory tract.

Standards exist for both types of mask, which fall within different legal scopes. They have each been designed and tested in the main for the protection they afford in one direction only (protection either of the wearer, or of other persons). FFP masks lie within the scope of the Personal Protective Equipment (PPE) Regulation (EU) 2016/425 and are designed to protect the wearer against particles (including aerosols) in accordance with the EN 149 harmonized standard¹. Surgical masks lie within the scope of the Medical Devices Regulation (EU) 2017/745 and are designed against the EN 14683 harmonized standard². Their primary function is to protect other persons against being infected by the wearer.

In the past, uses of these two mask types reflected these different purposes. FFP masks were used primarily during work with aerosols of any kind, including dusts. In some cases they were also used in the medical field, such as on tuberculosis wards, for protection of the personnel wearing them. Surgical masks were used primarily in the healthcare sector to contain the transmission of pathogens from personnel to immunodeficient patients (in particular during surgery, hence their name). In undefined infection scenarios however, as in a pandemic, it is often not known who presents an infection risk and on what scale, and who is in particular need of protection.

European standardization project for a new mask type

During the course of the COVID-19 pandemic, both types of mask were included in the German occupational safety and health regulations, to help control undefined infection scenarios, including at workplaces. The aim was to provide workers with the best possible protection against being infected with airborne viruses, whilst at the same time offering the best possible wearer comfort. Ideally, the masks would protect both the wearer and other persons. However, the masks used to date are not specifically designed and tested for this purpose. FFP2 masks do however appear to provide some degree of protection for other persons, and surgical masks some degree of protection for the wearer³.

In 2021, DIN launched a European standardization project for a new type of mask (“infection protection mask”) intended to provide demonstrable protection against infection for both the wearer and other persons. Work on this project at European level is already in progress (German).

The aspects to be covered by the new standard include the following:

• Requirements for protection of the wearer and other persons in an infection scenario, and corresponding test procedures (for example for leakage and filter performance)
• Compliance with the Medical Devices Regulation and the PPE Regulation
• Graded performance classes (for masks used by the general public and by employees at work)
• Clear labelling on the masks to facilitate selection of an appropriate mask for the risk
• A range of sizes, including sizes for children and other special user groups
• Usability (ergonomics, breathing resistance)

Relevance to occupational safety and health

Since these infection protection masks could also be used to protect employees, occupational safety and health stakeholders consider this standardization project highly significant. KAN moderated discussion of the standardization project by the OSH stakeholders, and submitted the results to the standards committee. The area of market surveillance is still considered a challenge, since the new mask type falls within the scope of several areas of legislation, and consequently multiple jurisdictions. There is also concern among users that yet another mask type could add to the confusion already arising during the COVID-19 pandemic with respect to the different mask types available, to the detriment of arrangements at company level and their acceptance. Despite these issues, a carefully prepared standard is seen as having considerable potential for occupational safety and health. This potential arises from the scope of such a new standard to combine test methods for protection of the wearer and of other persons against infectious airborne pathogens, and also to improve labelling significantly.

Mere development of a European standard for infection protection masks does not necessarily mean that the masks must actually be used at the workplace in the future. The national regulators first evaluate to what extent the masks described in the standard are able to deliver the required level of protection in various application scenarios. Provided the new mask type passes this test, the standard could also be referred to in the national occupational safety and health regulations. Only then could infection protection masks be used on a wider scale in workplaces.

OSH stakeholders are represented on the national and European standardization committees. KAN supports their work and will continue to monitor the standardization project in order to submit OSH concerns as effectively as possible.

Dr. Anna Dammann
dammann@kan.de

Dr. Anja Vomberg
vomberg@kan.de

Dr. Michael Thierbach
thierbach@kan.de