The British Standards Institution (BSI) offers an overview of global regulation for manufacturers of personal protective equipment (PPE), as well as those who are producing equipment for healthcare applications during the COVID-19 pandemic.
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. To ensure PPE is fully compliant, products have to be certified to the requirements of the regulation. This can be done through testing the product to a published harmonised standard or to a technical specification that meets the health and safety requirements of the regulation.
A harmonised standard is a European standard developed by a recognised European Standards Organization: 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.
Specifiers and purchasers of PPE can derive a measure of reassurance about the quality and safety of products from the presence of the ‘CE’ marking. When it comes to distributing PPE in the European Union (EU), all products that fall under the European Regulation must carry the CE marking. This is a legal requirement and means that manufacturers are allowed to do business in all 28 EU member states. For instance, once a CE approval has been issued in the UK the product can be sold across Europe – from Portugal right through to Greece.
If a product 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 and that they make available on the market only products 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.
In response to the European Commission’s request and in association with CEN, the European Committee for Standardization, and CENELEC, the European Committee for Electrotechnical Standardization, 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, plus 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.
A global perspective
Different regions throughout the world have their own local certification processes for PPE. For example, the UAE has ESMA certification. With Australasia, the USA and Canada all having their own product specifications and regulatory needs, a potential exporter should be aware of any local requirements before shipping PPE to that region.
ESMA is very similar to the PPE Regulation in that it splits PPE into three different categories; Category I, II and III. There are two different certification modules to choose from, which is EQM that involves a factory assessment and report review and is valid for three years or ECAS which involves a report review and is valid for one year.
Most regions have their own standards for products, but as we are seeing a wider growth or ISO specifications, these are becoming more commonly adopted for European specifications.
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 France and Germany there are standards being produced for barrier-type masks for people to wear in public, so it may not be too long before these are standardised across several countries.
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.
Nathan Shipley is PPE Group Certification Manager at BSI