Testing and certification of filtering face masks
Testing and certification of filtering face masks in accordance with the European standards, including EN 149 for personal protective equipment (PPE) for manufacturers, importers, and distributors.
If you want to market and sell face masks in the EU, including the Danish market, they must be CE marked. This enables you to document that the face masks meet the requirements for safety under the European standards, including EN 149 for personal protective equipment.
In addition to filtering face masks, categorised into FFP1, FFP2 and FFP3, a number of other types of face masks exist. This includes e.g. face masks made from silicone, with or without replaceable filters, etc.
We offer accredited testing of the following products:
- Filtering face masks – includes FFP1, FFP2, FFP3 (EN 149)
- Silicone masks (EN 1827)
- Filters for face masks (EN 143)
- Half masks (EN 140)
Following you can get your product certified and CE-marked by a notified body e.g. FORCE Certification.
How to get your face masks CE marked
In order to have a filtering face mask CE marked, the manufacturer must prepare the necessary technical documentation for the product in question – see description in Annex 3 of the Regulations of Personal Protective Equipment.
It sets the requirements for the accredited testing of the product so that the quality and safety comply with the requirements of the standard. It is therefore important to choose an accredited test laboratory to ensure that the issued documentation meets the requirements in the certification process.
Finally, a conformity assessment must be carried out by a notified body, such as FORCE Certification. If approved, the notified body issues a CE marking which allows the product to be sold on the European market.
What is your responsibility as a manufacturer, importer, or distributor of face masks?
If you import face masks from a manufacturer outside of the EU and the product is not CE marked from a notified body in the EU, you as the importer are responsible for having this process completed.
This applies regardless of whether you sell the product on to a retailer or whether you are a retailer yourself. By completing this process, you will be registered as a representative for the manufacturer of the product, and you are thus responsible for the product and the enclosed documentation.
How to ensure the quality of your face masks
Are you establishing a completely new production of personal protective equipment, or do you need to replace raw materials due to supplier problems?
We can help you out and we offer e.g. three levels with regard to testing and approval:
- An early screening – we examine the product or material and assess whether there is reason to continue with the product development.
- For manufacturers who have a finished product and who need a quick approval for use during the Covid-19 pandemic, we offer a simplified test and a temporary approval.
- A full test with test report and approval ready to be used for certified and thereby also for use after the Covid-19 pandemic.
We also offer to review the accompanying documentation from the manufacturer in relation to the requirements of the European standard and credibility. Similarly, we offer sample inspections of imported products.