Standards and labels

• EN 455-2:2015

  EN 455-2:2015 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for physical properties, dimensions, packaging, freedom from holes, freedom from powder, freedom from protein, freedom from endotoxins, and freedom from pyrogens. Test results can include measurements of the gloves' physical properties, dimensions, packaging, freedom from holes, freedom from powder, freedom from protein, freedom from endotoxins, and freedom from pyrogens. This version of the standard includes some changes and updates from the 2009 version.

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• EN 455-3:2015

  EN 455-3:2015 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for physical properties, dimensions, packaging, freedom from holes, freedom from powder, freedom from protein, freedom from endotoxins and freedom from pyrogens. Test results can include measurements of the gloves' physical properties, dimensions, packaging, freedom from holes, freedom from powder, freedom from protein, freedom from endotoxins and freedom from pyrogens. This version of the standard includes some changes and updates from the 2006 version.

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• EN ISO 9001:2015

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• ISO 13485

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• 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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• ISO 15223-1:2021

  ISO 15223-1:2021 is a standard that specifies general requirements for symbols that are intended to be used on medical devices and in medical device packaging, labeling, or instructions for use. It includes requirements for how symbols should be designed, tested and used to ensure they are easily understood by the intended users and to help prevent errors. Test results can include information on how well the symbols are understood by the intended users, how well they conform to the standard's requirements, and how well they help prevent errors. The standard also includes requirements for how the symbols should be labeled to indicate their intended use and meaning.

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• EN 455-4:2009

  EN 455-4:2009 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for freedom from holes, dimensions, packaging, freedom from powder, freedom from protein and freedom from endotoxins. Test results can include measurements of the gloves' freedom from holes, dimensions, packaging, freedom from powder, freedom from protein and freedom from endotoxins.

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• EN 455-1:2020

  EN 455-1:2020 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for freedom from holes, tensile strength, elongation, packaging, freedom from powder, freedom from protein, freedom from endotoxins, and freedom from pyrogens. Test results can include measurements of the gloves' freedom from holes, tensile strength, elongation, packaging, freedom from powder, freedom from protein, freedom from endotoxins and freedom from pyrogens. This version of the standard includes some changes and updates from the 2000 version.

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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.