The French standards association, AFNOR, has released AFNOR SPEC S76-001 “Masques barrières” or “Barrier Masks” (in English), a guideline that establishes minimum requirements for general purpose (non-medical) woven masks.
AFNOR Group designs and deploys solutions based on voluntary standards around the world. The Group serves the general interest in its standardization activities and provides services in such competitive sectors as training, professional and technical information and intelligence, assessment and certification.
AFNOR sponsored a group of industry experts along with members of standardization commissions for personal protective equipment (PPE) and for textiles. The guideline provides the minimum requirements, methods of testing, fabrication and use of general-purpose woven barrier masks.
Per the guideline, a woven “barrier mask” is intended for use by healthy people not exhibiting clinical symptoms of viral infection and not being in contact with people with such symptoms. Such masks do not provide the same medical benefits or protection than those for which EN 14683 (medical masks) or EN 149 (respiratory protective devices) are applicable.
AFNOR SPEC S76-001 masks are not medical devices, and thus are not within the scope of Medical Device Directive 93/42/EEC or Medical Device Regulation (EU) 2017/745. Neither are they PPE, and thus do not fall under the scope of Regulation (EU) 2016/425.
In an industry landscape typically dominated by medical and protective masks/respirator performance standards, SPEC S76-001 becomes one of the few standards that addresses general purposes woven masks. Viewed as critical to address mask shortages; woven masks allow for reusability while their construction leverages the much large textile industry instead relying solely on nonwovens. Furthermore, this allows medical masks to be prioritized to healthcare workers and patients.
As COVID-19 continues to develop, Governments have been increasingly recommending citizens to wear masks in public, protecting both themselves and workers providing essential services to public. This has led to sharp increase in the demand for general purposes masks. Manufacturers seeking to meet this demand can now look to SPEC S76-001 to ensure their masks meet an acceptable level of performance and safety.
AFNOR SPEC S76-001 requirements include, but not limited to:
- Visual Inspection and Dimensions
- Packaging and Materials
- Marking and Labelling
- Cleaning and Drying
- Breathing Resistance (Breathability), and
- Penetration Resistance (Particulate Filtration)
A critical component to the guideline is washing and drying, as the manufacturer must decide:
- Mask washing instructions
- Duration of use before mask should be washed (4 hours maximum)
- The maximum number of washes before mask should be disposed
To validate efficacy, the penetration and breathability tests are to be performed after the maximum number of washes. Product must meet minimum specified penetration and breathability requirements. The penetration of the barrier mask shall have either a filtering capacity of 70% for solid particles or for liquid particles (droplets) with a particle size spectrum extending up to 3 μm.
On 29 of March 2020 French Government issued a cross ministry (Labour, Health, Finance) instruction defining two categories of masks “Usage Non Sanitaire” (Non-medical purpose): UNS 1 and UNS 2.
- Cat I – UNS 1: for workers who have frequent and regular contact with the public such as policemen or cashiers
- Cat II – UNS 2: for people in a group wearing the same kind of masks (in a company, in a service, in a warehouse…), and who are occasionally in contact with public.
Using methodology referenced in AFNOR SPEC S76-001, UNS 1 Masks must perform at a 90% filtration level while UNS 2 masks must reach 70%. The cross ministry note, also specifies breathing resistance requirements, marking, minimum number of washes, like AFNOR SPEC S76-001.
SGS has gathered multiple experts to study the AFNOR guideline and the French Government’s cross ministry instruction to prepare testing and inspection protocols. Combining our experts from our various laboratories (Filtration, medical devices, medical supplies, personal protective equipment, and textile experts) we offer a unique multi-faced solution. Allowing our clients to verify their compliance to AFNOR SPEC S76-001 and Ministry instruction, through testing of the prototype, inspection of the production lots, with possibility of additional critical tests from the production lot.
SGS MEDICAL PPE SERVICES
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