New AFNOR Guidelines for General Purpose Face Masks

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

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.

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.

Subscribe here to receive SGS SafeGuardS direct to your inbox.

For further information contact:

Matthew Mcgarrity
Senior Technical Manager
Tel: +1 (973) 461 1505

Pierre-Jean CAVAROC
Expert – MedDev and Packaging – SGS France
Tel: +33628502692

Sales account manager – SGS France
Tel: +33 (0)6 7519 5046



LinkedIn: sgs-consumer-goods-&-retail

About SGS

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.

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top