BSI guide to masks and face

coverings for use in the UK

during the COVID-19 pandemic

V1.4 June 2020

If you are manufacturing PPE

Introduction

As the UK moves to the stage of recovery from the COVID-19 pandemic, people are asking how they

should protect themselves in different environments. One of the most common forms of protection

use in healthcare settings and by workers requiring protective equipment) and face coverings (for

use by the general public). It can also be used by businesses to help them provide the appropriate

protection for their employees.

If you are involved in procuring PPE

If you are a member of the public

Overview of masks and face coverings

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This paper gives a high level overview of the differences

between the four main types of mask and face covering

that are being used in the UK and throughout Europe

to protect against the risk of coronavirus. Background

people you do not normally meet. These face coverings

are not the same as the surgical masks or protective

masks used by healthcare and other workers as part of

personal protective equipment.

Manufacturers of protective or medical face masks need

to meet the requirements of the PPE Regulation, the

Medical Device Directive or both and these products must

feature the CE marking. This guide details some of the key

technical specifications of which you need to be aware.

To protect people effectively, it is important to select the

Surgical face masks are intended to limit the transmission of infective agents.

Surgical face masks can also incorporate a microbial barrier that is designed to be effective in reducing the emission

of infective agents from the nose and mouth of a carrier or a patient with clinical symptoms. Surgical masks are

intended to be a barrier to infection of others though they do offer limited protection to the wearer.

Surgical face masks are classified into two main types;

particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in

an operating room or in other medical settings with similar requirements.

These masks, unlike surgical masks, protect the wearer from inhaling infectious agents or pollutants in the form of

aerosols, droplets, or small solid particles. The wearer must be free of facial hair for this type of mask to be effective

and should be ‘fit tested’ to ensure that the wearer has the appropriate, specific mask. These masks can be used in

domestic, industrial and healthcare applications.

The EN 149 standard defines three classes of filter efficiency for these masks;

• FFP1 – 80% filtering efficiency

• FFP2 – 94% filtering efficiency

• FFP3 – 99% filtering efficiency

In the current COVID-19 situation, the World Health Organization (WHO) is recommending the minimum of an FFP2

mask for offering protection. The NHS is stipulating FFP3 in high risk areas and FFP2 in lower risk areas.

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quickly as possible. They have set out two routes for the assessment of PPE depending on the scale of manufacture

and who will be using the PPE. This guidance can be found here - please copy the URL and paste into your browser:

https://www.gov.uk/guidance/opss-coronavirus-covid-19-guidance-for-business-and-local-authorities

Where there is a requirement for conformity assessment by a Notified Body, BSI has implemented a number of

procedures to speed up the certification of masks, gowns, gloves and face shields for frontline healthcare workers.

Given the urgency of the situation and the specific situation of healthcare workers, it has been agreed at European

level that the full requirements of the PPE Regulation and Medical Device Directive need not be applied. Instead the

European Commission has published a recommendation, Recommendation 2020/403 that invites Notified Bodies

such as BSI to consider a minimum test requirement for the specific circumstances of healthcare workers.

To meet this, BSI has developed a stream-lined test specification for PPE suitable for use during the emergency,

Module B and C2 to the PPE regulation. These masks will therefore qualify for the CE Marking for the duration of the

pandemic under Recommendation 2020/403.

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The UK Government has issued advice for the use of a face covering in enclosed public spaces where social

distancing isn’t possible and where you will come into contact with people you do not normally meet. This is most

relevant for short periods indoors in crowded areas, for example, on public transport or in some shops. The advice

refers to evidence suggesting that face coverings do not protect the wearer but may provide some protection to

guidance for manufacturers and makers of face coverings - please copy the URL and paste into your browser:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/891041/

Guidance-for-businesses-and-individuals-face-coverings-version-2.pdf

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the virus and other products such as face coverings. It includes intended users, the protection offered, the applicable

regulations and the relevant UK regulator or enforcement authority.