If PPE bears the CE marking, it has been assessed against the essential safety performance criteria as specified in the EU Regulation. This mark also acts as the manufacturer’s confirmation that the product adheres to the specific requirements of all the Directives that apply to it and that it can be sold legally in the EU.
Previously the PPE Directive focused only on manufacturers placing products onto the market, but the PPE Regulation means the whole supply chain is involved. This means importers, distributors or anyone involved in the supply and distribution chain should take appropriate measures to ensure that PPE meets standard requirements. They should also ensure they only make products available on the market which comply with the Regulation and keep relevant documents for at least 10 years.
BSI’s status as a notified body for many European Directives and Regulations enables it to offer third party testing and factory production control assessments, where products require it, and can offer support for PPE manufacturers wishing to CE mark their products. The level of involvement of BSI is determined by the Category the product falls under in the Regulation.
The European Commission recommendation
When the European Commission issued recommendation 2020/403 to increase the amount of PPE that could be used by healthcare professionals in the fight against COVID-19, notified bodies were encouraged to process applications for CE marking swiftly and to consider non-harmonised standards for certification. This was to enable more product to be placed on the market in the EU more quickly.
Harmonised standards are listed in the Official Journal which is held on the European Commission website and is a ‘live document’ therefore updated on a regular basis.
A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC or ETSI, created following a request from the European Commission. Non-harmonised standards comply with directives, but non-harmonised standards do not automatically comply with the essential requirements of the directives.
In response to the European Commission’s request and in association with CEN, the European Committee for Standardisation, and CENELEC, the European Committee for Electrotechnical Standardisation, BSI has made a series of European Standards (ENs) for Personal Protective Equipment (PPE) used in the context of COVID-19 available free of charge on its website. This is to help support the efforts to fight the pandemic.
BSI has also produced a number of technical specifications to fast track the certification of PPE used by healthcare workers to enable it to get to those workers who need it most.
Additionally, BSI has created a guide aimed at organisations that do not normally manufacture PPE, so they can be clear of the obligations and how to ensure that the PPE is made safe to use.
The standards, which cover face masks, medical gloves, protective clothing and eye masks can be accessed here.
Conformity assessments and market surveillance
BSI is also supporting manufacturers with conformity assessments and market surveillance procedures within the context of COVID-19 with experts available to discuss the options for clients and other manufacturers.
This is to ensure compliant products can be placed on the market as quickly as possible, so that medical professionals and first responders have access to the equipment they urgently need.
During the COVID-19 pandemic, BSI was notified that a number of manufacturers were selling medical face masks – and other PPE for healthcare applications – on the back of false certificates.
BSI recommends that prior to purchasing any form of safety equipment supported by a certificate appearing to be issued by BSI, you verify to ensure that such certificate is genuine. BSI can only advise on false certificates that appear to have been issued by the organisation, it’s likely that other certification/notified bodies and approved test houses will also be affected by this.
Purchasers of any form of safety equipment supported by a certificate that appears to be issued by BSI should verify that the document is genuine using the certificate or license number and the Verifeye database on BSI’s website prior to purchase.
BSI has notified the relevant regulators and law enforcement agencies about the false certificates that have been brought to its attention.
Face coverings differ from PPE and medical grade face masks in that they are intended to protect those in close proximity to the wearer, not the wearer themselves, however they have become increasingly part of our everyday lives due to the COVID-19 pandemic.
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 new 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 new BSI Kitemark for Face Coverings provides independent approval of the quality of the fitting, and the instructions provided to the wearer to minimise the chances of transmission.
The BSI Kitemark continues to be the beacon of quality, performance and safety to both consumers and businesses – buying everything from fire extinguishers to secure digital services. Like all BSI Kitemark schemes, the new face coverings will be tested on an ongoing basis to ensure that manufactured products continue to meet the necessary requirements, year after year, in order to be trusted.
You can view more information about the Kitemark for Face Coverings, here.
As a result of the COVID-19 pandemic, we may see the development of standards specifically for PPE for healthcare workers as well as the general public.
In the continual fight against the COVID-19 pandemic, we are currently using standards that are designed to protect against different risks and hazards associated with different industries and applying them to healthcare situations. As the need for PPE amongst healthcare workers continues to take prominence, we will be seeing this as a factor in standards writing in the future.
One thing that has become apparent is that governments are looking to produce PPE domestically to be less reliant on imports which in some cases have been shown to be vulnerable to both quality and sustainability. Therefore, we might see more domestic manufacturing and perhaps more non-PPE manufactures making PPE as part of their portfolio as is the case with fashion designers including Burberry and Barbour.
BSI hosted a webinar to provide information to organisations wishing to support the efforts in placing more Personal Protective Equipment (PPE) on the market. The webinar is now available to watch – visit the BSI website for further information.