Standards and labels

• EN ISO 11137

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• 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 455-1

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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.