As governments begin advising citizens to wear face masks in response to the COVID-19 pandemic, and at a time when there is already an excessive demand for personal protective equipment (PPE) for frontline medical staff, one solution for manufacturers might be to product barrier masks that comply with AFNOR SPEC S76-001.
Issued by France’s standards association AFNOR, SPEC S76-001 establishes minimum requirements for general purpose, i.e. non-medical, woven masks. These requirements include:
• Visual Inspection and Dimensions
• Packaging and Materials
• Marking and Labelling
• Cleaning and Drying
• Breathing Resistance (Breathability)
• Penetration Resistance (Particulate Filtration)
A critical part of the guidelines relates to the washing and drying of general-purpose woven barrier masks. The manufacturer must decide:
• Mask washing instructions
• Duration of use before mask should be washed (4 hours maximum)
• Maximum number of washes before mask should be disposed
Penetration and breathability resistance tests must be performed after the maximum number of washes. The product must meet minimum specified penetration and breathability requirements. The barrier mask must have the following minimum filtering capacity:
• Solid particles – 70%
• Liquid particles (droplets) – particle size spectrum up to 3 μm
AFNOR SPEC S76-001 masks are not medical devices and do not come under the scope of either the Medical Device Directive 93/42/EEC or its replacement the Medical Device Regulation (EU) 2017/745. They are also not PPE and so do not fall under the scope of Regulation (EU) 2016/425. They do not offer the same medical benefits or protection as masks that comply to:
• EN 14683 – medical masks
• EN 149 – respiratory protective devices
They are intended for use by healthy people who are not exhibiting clinical symptoms of viral infection, and who have not been in contact with people who have symptoms of viral infection.
The methodology included in AFNOR SPEC S76-001 will assist manufacturers in meeting the requirements of a variety of non-medical woven masks. On March 29, 2020, the French Government issued a cross-ministry instruction that defines two categories of masks – ‘Usage Non Sanitaire’ (non-medical):
• Category I – UNS 1: for workers who have frequent and regular contact with the public such as policemen or cashiers
• Category 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
The cross ministry note covers several aspects also covered in AFNOR SPEC S76-001 (breathing resistance requirements, marking, minimum number of washes) and its methodology can be used to test performance:
• UNS 1 – masks must perform at a 90% filtration level
• UNS 2 – masks must perform at a 70% filtration level
The publishing of AFNOR SPEC S76-001 gives manufacturers a set of requirements to create viable barrier masks that are clearly differentiated from medical PPE. This will therefore take some of the strain off medical PPE supplies.
SGS Medical Device Services
SGS offer a full range of testing, auditing, and consultation services for face masks and other forms of PPE. Its experts have also developed a comprehensive service to help manufacturers verify their barrier masks against both AFNOR SPEC S76-001 and France’s instruction. Learn more about SGS’s Medical Device Services. [www.sgs.com/en/consumer-goods-retail/medical-devices]
SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full AFNOR Releases General Purpose Mask Standard SafeGuardS. [www.sgs.com/en/news/2020/04/safeguards-05020-afnor-releases-general-purpose-mask-standard]
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For further information contact:
Senior Technical Manager
Tel: +1 (973) 461 1505
Expert – MedDev and Packaging – SGS France
Sales account manager – SGS France
Tel: +33 (0)6 7519 5046
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.