SAFEGUARDS | Personal Protective EquipmentNO. 100/20
Community face coverings are typically not within scope of relevant personal protective equipment (PPE) and medical devices regulations, leaving undefined labeling, design, and efficacy requirements. In response CEN, the European Committee for Standardization, has released Workshop Agreement, CWA 17553:2020.
Overview
Fully titled 'Community face coverings - Guide to minimum requirements, methods of testing and use', CWA 17553:2020 specifies the minimum requirements for reusable or disposable community face coverings and materials intended for the general public, including adults and children aged 3-12 (when being supervised by an adult).
Product Scope
These coverings have become a mainstay in mitigating the spread of COVID-19 and seek to minimize the projection of a non-symptomatic or asymptomatic user's respiratory droplets saliva, sputum or respiratory secretions when talking, coughing or sneezing.
Although not intended, community face covering may also limit penetration in the area of the user's nose and mouth of respiratory droplets of external origin, without claiming user protection. It also prevents this area of the user's face from coming into contact with their hands.
Requirements
CWA 17553:2020's critical requirements include, but are not limited to:
- Design: Dimensions, Adult and Child Sizing, Material Selection
- Markings: Instructions for Use and Cleaning, Filtration Level, and Intended User
- Cleaning Requirements: Reusable products shall withstand claimed number of wash cycles (at least 5) with a minimum washing temperature of 60°C
- Performance: Durability, Particle Filtration and Breathing Resistance
Barrier Performance
Aligned with the use currently defined by national authorities, CWA 17553:2020 establishes two filtration levels for community face covering material:
- Level 90%: greater than or equal to 90%, 3 (± 0,5) µm
- Level 70%: greater than or equal to 70%, 3 (± 0,5) µm
While achieving one of the above filtration levels, the covering's material must also demonstrate acceptable levels of breathability, citing multiple acceptable methods for breathing resistance and air permeability.
Importantly, the above filtration and breathing resistance requirements apply to both new face covering materials and to materials that have been through the specified number of cleaning cycles.
Limitations
As a CEN "Workshop Agreement", CWA 17553:2020 is not an official standard and in no way be held as being an official standard developed by CEN and its Members.
The formal process followed by the Workshop in the development of this CWA 17553:2020 has been endorsed by the National Members of CEN, neither the National Members of CEN nor the CEN-CENELEC Management Centre can be held accountable for the technical content of this CEN Workshop Agreement or possible conflicts with standards or legislation.
SGS is committed to providing information about development in regulations for consumer products as complimentary services. Through a global network of laboratories, SGS provides a wide range of services including physical/mechanical testing, analytical testing and consultancy work for technical and non-technical parameters applicable to a comprehensive range of consumer products. Please do not hesitate to contact us for further information.
NEXT STEP:
Available for free download from the CEN and CENELEC website and from the websites of CEN national members, CWA 17553:2020 can be found at this link:
ftp://ftp.cencenelec.eu/EN/ResearchInnovation/CWA/CWA17553_2020.pdf
Participating in the research and development of many face mask and face coverings guidance documents, SGS can assist manufacturers with properly utilizing the provide information to evaluate their covering, through testing of the materials, inspection of the production lots, with possibility of additional critical tests from the production lot.
For enquiries, please contact:
Matthew McGarrity
Hardlines Technical Manager
t: +9738978889
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