Elers Medical IIR Face Mask

Standards and labels

• EN 14683:2019

  EN 14683 is a European standard for face masks. It includes requirements for mask design, testing, and labeling. Test results include things like filtration efficiency and breathability. The standard also includes requirements for packaging and labeling. The 2019 version updates the previous 2014 version.

  Test results

  Bacterial Filtration Type IIR

  The Bacterial Filtration Efficiency (BFE) result for Type IIR in the standard EN 14683:2019 assesses the efficacy of medical face masks in preventing the passage of aerosolized bacteria. This is crucial for medical environments to ensure a high level of protection against potential bacterial infections transmissible through human respiratory droplets. For Type IIR under EN 14683:2019, the bacterial filtration efficiency test involves determining the percentage of bacteria-laden aerosols that do not pass through the mask material. Masks must demonstrate a BFE of ≥98% at a specified bacteria challenge load, ensuring superior filtration capabilities. This higher requirement reflects Type IIR's application in environments where exposure to blood and bodily fluids is possible, granting them suitability for surgeries and other medical proceedings where stringent sterile conditions are essential.

• MD Label

  MD stands for "Medical Device." It refers to any instruments, apparatus, machines, implants, or other similar or related articles that are intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability. In Europe, a MD Label is a special label that must be on all Medical Devices that are sold or used in the European Union (EU). The label must include information about the product, such as the name of the manufacturer, the intended use of the product and CE mark. To be able to sell or use a Medical Device in the EU, the device must meet certain standards and requirements set by the European Union and notified body.

• 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.