Testing of medical face masks
Accredited testing and assistance for CE registration of medical face masks in accordance with the applicable standard EN 14683 for medical equipment for manufacturers, importers, and distributors.
Medical face masks are also known as surgical face masks or disposable face masks. If you want to market and sell medical face masks in the EU, including the Danish market, they must be CE marked and registered.
We offer accredited testing of medical face masks in collaboration with our European partner. This allows you to secure the necessary documentation and acquire the CE marking for your product. This means that you can provide proof to customers and authorities that your product meets the requirements of the applicable standard EN 14683, and thereby can get through customs upon import and be sold legally on the European market.
Depending on the filtering ability, medical face masks are categorised as type I, type II, or type IIR. Moreover, medical face masks can be further divided into sterile and non-sterile face masks. We offer accredited testing in accordance with EN 14683 of all types of medical face masks, ensuring that they live up to the requirements.
We also offer accredited testing of filtering face masks and community face covers.
How to get your medical face masks CE marked
As a distributor of medical face masks, you are responsible for ensuring that the product that you sellis CE marked and that correct documentation, etc. is enclosed.
For medical devices, the manufacturer is responsible for ensuring that the product meets the requirements of the standard and thereby can be CE marked. In the case of medical face masks, the manufacturer is responsible for the process of CE marking. However, the manufacturer must at all times be able to submit proof to the authorities that the product complies with legislation. This can be achieved by presenting an accredited test report.
Read more about how to get your medical face mask CE marked and what you need to pay special attention to in our guide: CE marking of medical face masks.
Accredited test laboratory
FORCE Technology is accredited by DANAK (65 and 8) for testing personal protective equipment. In collaboration with a European partner, we offer accredited testing of medical face masks.