Standards and labels

• EN 13485:2016

  EN 13485:2016 is a standard for a Quality Management System for Medical Devices. It sets out the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. This standard is used to demonstrate a company's ability to meet specific quality and safety requirements for the design, production, installation and servicing of medical devices. Test results can include audits and inspections of the organization's facilities, processes, and products to ensure compliance with the standard.

  Reach out to ask about the standard test results

• 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 II

  The Bacterial Filtration result for Type II in the EN 14683:2019 standard specifies a minimum bacterial filtration efficiency (BFE). The standard requires that Type II medical face masks must achieve at least a 98% BFE, which means that they are capable of filtering out at least 98% of the bacteria present in the testing aerosol. This is crucial for ensuring a high level of protection against the transmission of bacteria through respiratory droplets.