Kolmi Softex Mask with Earloops, Type II Kids, Blue

Standards and labels

• ISO 13485:2016

  ISO 13485:2016 is a standard that specifies requirements for a quality management system for the design and manufacture of medical devices. It includes requirements for how companies should design, implement, maintain and improve their quality management system to ensure that their medical devices are safe and effective. Test results can include information on how well the quality management system is functioning, how well it is being followed, and how effective it is in preventing defects. The standard also includes requirements for how the company should document and record their quality management system performance and continuously improve it.

  Test results

  Medical Management Passed

  The ISO 13485:2016 standard is specifically tailored for medical device manufacturers and aims to ensure the quality and safety of medical devices throughout their production and lifecycle. A test result of Passed in the context of the ISO 13485:2016 standard signifies that the medical device manufacturing management system under assessment has successfully met all regulatory and safety requirements stipulated in the standard. This encompasses rigorous evaluations of the manufacturer's quality management system, including processes like risk management, regulatory compliance, and effective process control. The assessment involves auditing processes such as document review, facility inspection, and staff interviews, to verify the adequacy and effectiveness of the quality management system. Meeting the ISO 13485:2016 requirements assists manufacturers in achieving and maintaining regulatory compliance and ensures that their products consistently meet user needs and applicable regulatory standards, which is crucial for entry and continued presence in global markets.

• EN ISO 11737-1:2018/A1:2021

  EN ISO 11737-1:2018/A1:2021 is a standard that defines how to test the sterilization of medical devices. It includes requirements for the methods used to sterilize the device and how to test to make sure the sterilization process was successful. Test results should show that the device is free from harmful microorganisms and safe for use. It was amended in 2021 which is why it has A1 at the end of the name.

  Reach out to ask about the standard test results

• 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 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.

• 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.

• 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.