The use of masks has become a standard in the workplace since the start of the COVID-19 health crisis, which has resulted in an increase in the demand for this product and, sometimes, the necessity to import it in bulk from other countries. Mask manufacturers have the need and the responsibility to ensure that their product is compliant with the current norms and distributors can contrast the credentials provided by the export agents art the country of origin to make sure that the masks they receive are compliant with the current requirements.
The market for personal and professional masks has three main types: PPE masks, medical masks, and hygienic masks.
They are considered a Personal Protection Equipment (PPE) and are the type of mask that should be use in a professional environment. They filter the inhaled air to prevent the entry of contaminated particles in the user’s organism. The FFP2 and FFP3 types that have an exhale valve must be used in conjunction with a medical mask to prevent the infection of other users.
PPE masks are certified via CE Marking according to norm EN 149 (Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking). Applus+ has ENAC’s certification (nº 12/C-PR054) for CE Marking under Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment (PPE), modules B and C2, for masks.
They are the ones meant to prevent the user from spreading infectious agents by filtering the exhaled air. The Spanish Agency for Drugs and Medical Products (AEMPS) establishes that the evaluation of conformity must be conducted according to norm EN 14683 (Medical face masks - Requirements and test methods). Applus+ has the certification of conformity according to this norm.
It’s a product meant for healthy users. Applus+ has available a proprietary certification scheme for manufacturers that wish to prove the conformity of their masks in relation to the following specifications:
- UNE 0064-1 (Non-reusable hygienic masks. Materials, design, manufacturing, marking and use requirements. Part 1: For adult use)
- UNE 0064-2 (Non-reusable hygienic masks. Materials, design, manufacturing, marking and use requirements. Part 2: For children use)
- UNE 0065 (Reusable hygienic masks for adult and children. Materials, design, manufacturing, marking and use requirements)
Applus+ Laboratories offers a complete service of either Certification or Certification Contrast
We offer two types of service for manufacturers and distributors:
Testing and Certification: For either CE Marking or the proprietary Applus+ certification scheme. Our service includes:
- Sample collection for testing, in case it is required.
- Testing according to current legislation.
- Check-in inspections of the factory production control system, in case it is required.
Certification Contrast: To corroborate the certifications issued in other countries and ensure that the products received comply with the established regulations and purchase requirements. The service includes:
- Inspection at port of origin.
- Random sample collection at port of origin.
- Testing at our own laboratories of the collected samples.
- Issuance of the Contrast Report.
Contact our experts to solve any doubts about the certification process for each type of mask.