Meditrade BeeSana® Gauze Swab, Without X-Ray Detectable Thread, Non-Sterile, 20 x 20 cm, Round, Plum-Sized

Standards and labels

• 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 14079:2003

  EN 14079:2003 is a European standard for air terminals (air diffusers) used in ventilation systems. It sets requirements for the design, construction, testing and marking of air terminals to ensure they can withstand pressure, air leakage, and fire. Tests include leakage, pressure and fire resistance test. The standard applies to both circular and rectangular air terminals and it also specifies requirements for the documentation of the air terminal, including a declaration of performance, and the marking of the air terminal with the manufacturer's name or trademark and product information.

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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.