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The Covid-19 pandemic has brought the use of Personal Protective Equipment (PPE) into sharp focus.
What is PPE and what is it used for?
PPE is anything that is worn or held by a person to protect them from injury or infection and encompasses hundreds of products that stretch from head to toe, from protective clothing, helmets, hearing and respiratory protection to body armour, gloves, boots and fall protection.
However, in the context of Covid-19, PPE relates to items that many key workers, such as NHS staff, have been wearing to help stop the spread of Covid-19. These items include:
• Face masks
• Medical gloves
• Protective clothing
• Eye protection
To keep people safe and to reduce health risks, PPE has to comply with all the requirements of the PPE Regulation and carry the CE marking to be sold legally in the EU. However, for the UK market, from 1 January 2023, UKCA marking will replace traditional CE marking and all products that previously required the CE marking will need to have UKCA marking affixed by an approved body.
Northern Ireland can continue with CE marking or use CE and UKNI marking. More information can be found here: https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-great-britain
PPE Regulation
To ensure PPE is fully compliant, products must be certified to the requirements of the PPE Regulation 2016/425. This can be done through testing the product to a published harmonized standard or to a technical specification that meets the Annex II health and safety requirements of
the Regulation.
Harmonized standards are listed in the Official Journal which is held on the European Commission website. It is a ‘live document’ and therefore updated on a regular basis.
A harmonized standard is a European standard developed by a recognized European Standards Organization: CEN, CENELEC or ETSI, and was created following a request from the European Commission. Non-harmonized standards comply with directives, but non-harmonized standards do not automatically comply with the essential requirements of the directives.
PPE Regulation during the Covid-19 pandemic
The demand for PPE due to the Covid-19 pandemic has been high. To ensure enough product is placed on the market, the European Commission encouraged Notified Bodies to process applications for CE marking swiftly and to consider non-harmonized standards for certification.
However, products which were procured as a result of the EU’s ruling on PPE will no longer be procured by frontline healthcare organizations as from 30 June 2021. This means that all PPE manufacturers now need to be fully certified against PPE Regulation 2016/425 and the product specific European standard as from 30 June 2021 to enter the market.
The EU Commission’s guidance was given partly to enable more product being placed on the market in the EU more quickly and also to reduce the risk of medical professionals and first responders not having access to the correct or sufficient PPE.
The UK Government had announced that the majority of Covid-19 restrictions would be removed from 19 July. The easement that was put in place in regard to PPE has therefore also been rescinded.
UKCA Marking
From 1 January 2023, a new regulation will be required when placing products on the Great Britain (GB) market. Almost all products that previously required the CE marking will be required to be certified against the UKCA marking and this includes PPE.
In January, the Department for Business, Energy and Industrial Strategy (BEIS) informed BSI that it was an Approved Body (0086) for the UKCA marking. As an Approved Body, BSI can work with organizations on the required conformity assessment procedures that will allow them to affix the UKCA marking on to the following products:
• Construction products submitted to the Construction Products Regulation (CPR)
• Personal Protective Equipment (PPE)
• Gas appliances
• Pressure equipment
• Lifts submitted to the Lift Directive
• Marine equipment
• Measuring instruments
• Radio equipment
There are roughly ten times fewer UK Approved Bodies who can provide the UKCA mark. Whilst not everyone will decide to sell their product in Great Britain, we expect a majority to do so and thus there may be a build-up of work for these UK Approved Bodies.
Most products currently covered by CE marking will require the UKCA marking from 1 January 2023 and manufacturers hoping to place products in the GB market are being advised to act now to avoid disappointment.
We have been in a transition period since we left the European Union on 31 January 2020; both the UKCA and the CE marking have been accepted, however, from 1 January 2023 this will no longer be the case. Most products placed on the market in Great Britain will require the UKCA marking and subsequently, the associated testing and certification to support the UKCA marking must be undertaken by a UK Approved Body. We are committed to helping our clients build resilience through this new regulatory landscape, however a significant number of manufacturers are yet to apply for UKCA marking. We urge all manufacturers who plan to sell their products in Great Britain from the 1 January 2023 to act now and avoid disruption to their supply chains.
Categories of PPE
PPE can be described as:
a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety
b) interchangeable components for equipment referred to in point (a) which are essential for its protective function
c) connection systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed nor require fastening works before use
There are three different categories for PPE:
Category 1 – Simple PPE: PPE in this category is designed to protect users against minimal risks including contact with hot surfaces not exceeding 50°C, contact with water or cleaning materials of weak action and superficial mechanical injury.
Category 2 – Intermediate PPE: This includes products such as safety spectacles and goggles, industrial helmets, bump caps, hi-vis clothing and other products not included in categories 1 and 3.
Category 3 – Complex PPE: This category includes exclusively the risks that may cause serious consequences such as death or irreversible damage to health. Those risks include substances and mixtures which are hazardous to health, and harmful biological agents.
PPE for Medical Use
The Medical Devices Directive 93/42/EEC was amended on 5 September 2007 by Directive 2007/47/EC of the European parliament. This meant that:
‘Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC and this Directive [93/42/EEC], the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.’
‘The measures shall apply from 21 March 2010’
Changes to Hearing Protection Standards
New standards relating to hearing protection have also been introduced this year. Electronic ear plugs must now be compliant for safety related audio input and entertainment audio facilities. The EN 352 suite of standards, for hearing protection, recently underwent a revision and now include updates around testing.
There are now also additional requirements in relation to user information whereby details of the mean test value must be included on the packaging or product literature. If space is limited, the packaging might need to be reformatted to enable inclusion.
“the EN 352 suite of standards, for hearing protection, recently underwent a revision and now include updates around testing”
In the past, these safety related audio inputs or entertainment facilities were only considered for larger hearing protectors but with the advancement of technology, since the last part of the EN 352 suite was written in 2008, it is now possible to have protective earplugs that can provide similar audio facilities as the earmuff counterpart.
To reflect this advancement on earplug capability two new standards have been introduced:
BS EN 352-9:2020
• Hearing protectors
• Safety requirements
• Earplugs with safety-related audio input
BS EN 352-10:2020
• Hearing protectors
• Safety requirements
• Entertainment audio earplugs
The requirements of these standards are similar to the standards for earmuffs.
• EN 352-9:2020 is the ear plug equivalent of EN 352-6:2020
• EN 352-10 is the earplug equivalent of EN 352-8:2020
Face coverings
Another big topic during the Covid-19 pandemic has been face coverings as they have become part of our everyday lives. This is because wearing a face covering may reduce the spread of coronavirus droplets in enclosed public spaces (shops, supermarkets, shopping centres, etc.), helping to protect others.
Face coverings differ to PPE because they are not assessed to the same regulatory requirements as PPE or Medical Device requirements. Face coverings are not considered PPE because they are intended to protect those in close proximity to the wearer, not the wearer themselves.
Whilst a vast number of face coverings are already available on the market, their performance and design may differ significantly, which is why BSI recently launched a Kitemark™ for face coverings to boost consumer confidence.
The Kitemark assesses face coverings to a technical specification that requires 70% particle filtration and breathability tests to ensure consumer comfort whilst reducing the risk of spreading infection. On top of breathability and filtering, the BSI Kitemark for face coverings provides independent approval on the quality of the fitting, and the instructions provided to the wearer to minimize the chances of transmission.
Specifically, the BSI Kitemark for face coverings tests that products meet a minimum requirement in terms of:
• a basic level of protection against the transmission of infected droplets
• the manufacture, design and performance of the covering
BSI also assesses whether:
• the head harness is designed to be put on or taken off easily
• it achieves 70% particle filtration when tested using the sodium chloride test method
• the wearer can breathe through the material to a certain resistance level
• it can be adjusted to fit different head shapes and sizes
• has clear instructions for use/fitting
• can withstand a minimum of five washing cycles (if a client’s product isn’t single use)
There is an overwhelming choice of face coverings available in the market. The challenge is knowing which claims they make are valid and whether they provide a basic level of protection to others. Face coverings that are independently assessed to schemes such as the Kitemark will allow consumers to make an informed decision and choose products they can trust.
You can view more information about the Kitemark for Face Coverings at https://www.bsigroup.com/en-GB/kitemark/product-testing/face-coverings/
