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.

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• EN ISO 9001:2015

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• EN 455-1

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• EN 455-2

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• EN 455-3

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• EN 455-4

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• EN 420:2003+A1:2009

  EN 420:2003+A1:2009 is a European standard that sets out the general requirements for hand protection, including comfort, fit, and dexterity. Performance requirements include resistance to abrasion, cut, tear, puncture, and impact. Test results should show the gloves meet these requirements.

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• EN ISO 374-1:2016/A1:2018

  EN ISO 374-1:2016/A1:2018 is a standard that sets the rules for gloves that protect against dangerous chemicals and microorganisms. It says how gloves should be made, what materials should be used, and how they should be tested. Possible test results include how well the gloves keep out chemicals, how long they last and how well they protect the hands. This amendment updates the original standard with new requirements.

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• EN 16523-1:2015+A1:2018

  EN 16523-1:2015+A1:2018 is a European standard that defines the performance requirements and test methods for automatic towel dispensers. It sets guidelines for how much towel should come out, how high the nozzle should be, and how hard it should be to activate the dispenser. The test results should show that the dispenser meets these guidelines.

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• EN 21171

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• EN 1186-1

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• Food Safe

  Food safe refers to the safety of food products that are used or consumed by people. In Europe, food safety is regulated by the European Union (EU) and the European Food Safety Authority (EFSA). These organizations set standards and requirements for food products to ensure they are safe to eat. To be considered "food safe" in Europe, a product must meet these standards and be free of harmful substances. This includes being free of harmful bacteria, pesticides, and other contaminants. Food products that do not meet these standards cannot be sold or used in the EU.