Standards and labels

• EN 14683:2019+AC:2019

  EN 14683:2019 + AC:2019 is a European standard that specifies the performance requirements and test methods for surgical face masks. The standard defines the mask's ability to filter bacteria and particles, as well as its breathability. The mask must also pass tests for flammability, splash resistance, and biocompatibility. The mask must pass all the test to be certified as a surgical mask.

  Test results

  Bacterial Filtration Type I

  The EN 14683:2019+AC:2019 standard specifies methods for testing the bacterial filtration efficiency (BFE) of medical face masks, defining specific protocols to assess the performance and safety of these products. The BFE test involves challenging the mask with a known quantity of bacteria, typically Staphylococcus aureus, to determine how well the mask can filter bacterial particles. The results indicate the percentage of bacteria that was prevented from passing through the mask. For the Type I mask under EN 14683:2019+AC:2019 standard, the bacterial filtration efficiency (BFE) result shows that it is designed to achieve a BFE of ≥ 95%. This level of performance is suitable for masks intended for use by patients and other individuals to reduce the risk of spread of infections, particularly in epidemic or pandemic situations, but are not recommended for use in surgical settings. This practical result identifies Type I masks as an effective barrier against bacterial penetration for general medical use but not for exposure to aerosols in surgical environments.

• Textiles

  Textiles are materials made from fibers, such as cotton, wool, or polyester. In Europe, there are rules for how textiles should be made, sold, and labeled. These rules are set by the European Union. These rules ensure that textiles are safe and do not contain harmful chemicals, that they are labeled correctly and that the use of certain dangerous chemicals are banned. These rules are set to protect the health and safety of consumers and the environment. Companies that make or sell textiles in the EU must comply with these rules.

• CE Marking

  CE Marking is a label that shows a product meets certain safety and environmental standards set by the European Union. To get the CE Marking, a company must test and certify their product meets these standards. CE Marking is required for many products sold in the EU, including electronics, machinery, toys and medical devices. It helps ensure that products are safe for consumers and the environment, and allows for easy trade within the EU.