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 IIR

  The Bacterial Filtration Efficiency (BFE) result for the Type IIR mask according to EN 14683:2019+AC:2019 indicates the mask's ability to block bacterial particles from passing through the material. For a Type IIR mask, this test evaluates whether the mask can maintain a BFE of ≥98%. The practical implication of this result for procurement professionals is that when they choose Type IIR masks complying with EN 14683:2019+AC:2019, they are selecting masks that offer a high level of bacterial filtration, suitable for environments where exposure to bacteria is a concern, such as medical facilities.

• EN ISO 13485:2016

  EN ISO 13485:2016 is a standard for quality management systems for medical devices. It sets guidelines for design and development, production, installation and servicing of medical devices. Test results include measurements of compliance with the standard's requirements. It also includes guidelines for continual improvement, risk management and regulatory compliance. This is a specific version of the standard, updated from the 2012 version.

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• EN ISO 9001:2015

  Test results

  Service Reliability Passed

  EN ISO 9001:2015 is a globally recognized standard that specifies requirements for a quality management system (QMS), focusing on numerous aspects of quality management in organizations, aiming to enhance customer satisfaction through the effective application of the system. The 'Service Reliability' with a 'Passed' designation indicates that an organization has successfully demonstrated its ability to consistently provide services that meet customer and regulatory requirements while aiming for continual improvement. This assessment involves evaluating various elements of the QMS including service planning, execution, and monitoring, to ensure reliability and performance consistency. The practical implications for organizations that pass this aspect of the standard are significant; it establishes them as reliable providers in their industry, enhancing customer trust and satisfaction, and potentially leading to increased business and a competitive advantage.

• EN ISO 11737-1:2018

  EN ISO 11737-1:2018 is a standard that tells how to make sure medical devices are cleaned and sterilized properly before they are used on people. It includes rules for the methods used to clean and sterilize the device, and how to test to make sure the cleaning and sterilization process was successful. Test results should show that the device is clean and free from harmful microorganisms.

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• 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.