Standards and labels

• EN 1041:2008+A1:2013

  EN 1041:2008+A1:2013 is a standard that sets safety requirements for the information technology equipment, including computers and peripherals. It defines performance requirements for the equipment such as the levels of electrical and magnetic fields they must be able to tolerate. Test results show how well the equipment meet those requirements, and if they pass or fail the test. It's an updated version of the 2008 standard.

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• 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.

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• EN ISO 9001:2015

  EN ISO 9001:2015 is a standard that sets out the requirements for a quality management system (QMS). It is a set of guidelines that organizations can follow to ensure that they meet customer requirements and enhance customer satisfaction. The standard is based on the plan-do-check-act model and focuses on continuous improvement. It covers the design, development, production, installation, and servicing of products. Organizations can get certified to this standard, which means that they have been independently audited and found to meet the requirements of the standard. The certification process includes regular audits to ensure that the organization continues to meet the standard's requirements.

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• EN 14971

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• 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.

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• ISO 15223-1

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• Made in Europe

  "Made in Europe" is a label used to indicate that a product has been manufactured or produced in Europe. The European Union (EU) has regulations that set the requirements for the "Made in" label. According to EU rules, products that are labeled as "Made in" must be entirely produced within the EU. This means that all the stages of production, from raw materials to the finished product, must take place within the EU. However, the EU does not have specific rules for labeling a product "Made in Europe" as a whole, because Europe is not a single country but a continent. Each country may have their own regulations for labeling a product "Made in Europe", and it's important to check the regulations of the country where the product will be sold.

• 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.