Mask Assessments 101
A Guide to Requirements for Face Coverings
17 November 2020
As countries around the world work to ensure that workers on the front lines, as well as citizens, are protected from COVID-19, consumer product brands and manufacturers have shifted production to fulfill the growing need for masks of all kinds: professional PPE, medical grade and consumer/fashion. Given their purpose, each type of mask has different requirements and standards to meet. It is important to understand what type of mask you're producing and what requirements are in place based on the category.
When it comes to fashion masks for consumers, it is advisable to check on requirements in the location where the item is to be sold. There are some EU countries, such as France and Spain, that have prepared guidelines for reference. The European Commission identified the urgent need for a harmonized and consistent degree of safety in community face coverings and, as such, the European Committee for Standardization (CEN) published guidelines for quality and compliance of community masks under CWA 17553:2020. The are countries where face coverings do not need to meet performance requirements. However, if any protective claim is made, the product may be within the scope of PPE regulations. Similarly, in the U.S., cloth masks cannot claim or imply any medical treatment implications.
Face covering and similar masks should not include claims around such as bacterial protection performance as this could be considered medical use. As consumer products, they must comply with the Consumer Protection Safety Information Act (CPSIA) and California's Proposition 65 in the US. They must also meet the relevant REACH requirements for restricted substances, including the Azo dyes restriction for Europe. In the U.S., they require textile labeling and fair packing and labeling requirements. In addition, standards development body ASTM International is spearheading a new effort to create a voluntary standard for fashion and community masks in the U.S., which will enable the Centers for Disease Control and Prevention to make recommendations to Americans that they purchase and wear masks made to ASTM standards.
When making the masks, remember that the care label should be accessible, though there is no specific requirement for positioning. Antimicrobial claims are not recommended for fashion face masks, as claims could be misleading and suggest that the mask offers bacterial protection, which, as mentioned above, they do not. In addition, because finishes will be in close contact with the face, mouth, and nose, toxicity should be considered for any applied treatment.
Medical masks, which include medical claims, must be compliant with various standards, depending on market. In the EU, they must comply with EN 14683. In the US, they should adhere to guidance within the Food and Drug Administration (FDA) Emergency Use Authorization (EUA). A non-EUA mask requires 510K registration with the FDA and formal data submitted supporting the application. In both the EU and US, breathability should be assessed to EN 14683 - ANNEX C.
Medical masks must also be assessed for BFE – assessing how it filters pathogens – and in the US particle filtration efficiency (PFE) is also required. As medical products, they must be manufactured in a sterile environment, meaning the production system is subject to an ISO 13485 Assessment, conducted by a Notified Body. Storage information should be on the packaging and in the EU, CE marking may also appear on the outer packaging.
Professional PPE (N95/KN95)
N95/KN95 respirators reduce a wearer's exposure to particles, filtering out at least 95 percent of very small particles, including bacteria and viruses. In the US, they must be evaluated, tested and approved by National Institute for Occupational Safety and Health (NIOSH), according to requirements established in NIOSH 42 CFR Part 84. NIOSH requires manufacturers to submit data proving the respirators comply with requirements, including precertification tests such as inhalation/exhalation resistance, particulate filtration efficiency, and valve leakage. Additionally, N95 masks used for medical purposes requires specific evaluations found within FDA docs 878.4040 and 880.6260. In the UK and EU, respirator masks (or filtering face pieces) must comply with EN 149 and be certified by a Notified Body.
Masks play an increasingly important role in the health and well being of people around the world. Understanding the requirements in place for a product can help get them assessed more quickly, saving time and money to get these in-demand products to market. Learn more about requirements for masks and other protective gear in our production guide.