Unmasking the Facts Behind Manufacturing Face Masks


Face masks became common sense in Asia after the SARS epidemic in 2002. They were no longer an indicator of disease and became more akin to putting on a jacket for cold weather.

Now, masks are mandatory in many countries around the world as a key measure to slow COVID-19 transmission. Protecting people from COVID-19 is a priority for individuals, organizations and governments.

Face coverings do not fall under the scope of PPE and the regulation medical mask. Surgical masks are not PPE as they fall under medical device directives/regulations and are Class I in most instances. They also do not require Notified Body intervention, so such bodies do not get involved with face coverings.

Types of face mask
Reusable fabric masks

Commonly used by the public, reusable fabric masks provide basic protection in everyday life. We have an IC Mark to demonstrate that your reusable fabric masks meet the highest quality and performance standards.

Medical masks

Also known as surgical and procedure masks, medical masks protect against contact with blood and other bodily fluids. They can be worn by medical staff, patients and others to reduce the spread of infections.


Regularly known as a filtering facepiece or half mask, respirators fit tightly and protect against inhaling hazardous materials and efficiently filter airborne particles.

COVID-19 protection

Due to the pandemic, respiratory protection (masks), face shields, coveralls and gloves have had the most requests for certification, with respiratory being the most common.

Respiratory protection falls under Category III (complex risk) PPE and needs both Module B product and Module C2/D certification.

ASTM F3502 – the new standard

Responding to the pandemic, ASTM F3502 was created to address extraordinary demand for face coverings. The scope ensures that coverings meet requirements, including source control for expelled droplets and aerosols, as well as potential particulate filtration. ASTM F3502 also has two performance levels – Level 1 (lower performance) and Level 2 (higher performance). These levels look at submicron particulate filtration efficiency and airflow resistance capabilities.

To receive an ASTM F3502 mark, you must:

  • Comply with all ASTM F3502 design, performance, reporting, labeling, user information and conformity assessment requirements.
  • Pass ISO/IEC 17025-accredited laboratory testing of submitted samples at stated performance levels.
  • Meet established requirements in declaration of conformity.
  • Maintain a quality management system with appropriate scope.
  • Monitor the product for conformity.
  • Implement retesting and inspection if the product changes.
  • Keep necessary supporting records establishing conformity.
Our expertise and offering

SGS understands the complexity of face covering and medical face mask requirements, especially in a COVID-19 world. Our testing and certification services verify your product’s effectiveness and compliance with your intended market.

Providing a one-stop shop, our global network of PPE experts and accredited laboratories ensure face mask and PPE product compliance, help with technical files and coordinate with Notified Bodies for EC-type examinations.

Our services include ISO 9001 and ISO 13485 quality management system certification. These recognized certifications will support self-attesting declarations and satisfy regulatory expectations. We also provide SGS-accredited laboratory testing and consultation on fabric masks to determine if your product’s performance satisfies regional specifications and share information on export/import procedures.




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