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 455-2

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• EN 420

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• EN 455-1

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• EN 455-3

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• EN 374-4:2013

  EN 374-4:2013 is a European standard for gloves that protect against microorganisms. It sets rules for how the gloves should protect against microorganisms and how to test if they meet the standards. Gloves that pass the tests can have a label that says they meet the standard. The test results can be pass or fail for each test that checks the gloves resistance to microorganisms.

  Test results

  Degradation Tested

  The standard EN 374-4:2013 pertains to the determination of degradation by chemicals for protective gloves. Degradation is assessed based on the change in physical properties of the glove material after contact with a chemical. Specifically, a result indicating degradation provides a measure of the glove's deterioration in terms of features like tensile strength and elongation when exposed to specific chemicals, gauged through physical tests such as elongation and tensile tests. The test method involves exposing the glove material to the chemical over a determined period, followed by mechanical testing to compare the pre and post-exposure properties. This result is crucial in determining the glove's suitability for use with specific chemicals, as degradation can significantly reduce its protective effectiveness, potentially endangering the user. Hence, understanding and adhering to this standard helps in the selection of appropriate protective gloves for specific chemical exposure scenarios, ensuring user safety and compliance with health and safety regulations.

• EN ISO 374-1:2016

  EN ISO 374-1:2016 is a standard that defines the performance requirements for gloves that protect against chemicals and microorganisms. The standard specifies the design, materials, and testing requirements for gloves to protect against chemicals and microorganisms. Possible test results include measurements of the gloves' permeation resistance, degradation, and penetration. It also includes the safety and functionality requirements for gloves.

  Test results

  Specified Requirements Type C

• EN 374-5:2016

  EN 374-5:2016 is a European standard for gloves that protect against microorganisms, specifically gloves that are used for medical and dental procedures. It sets rules for how the gloves should protect against microorganisms and how to test if they meet the standards. Gloves that pass the tests can have a label that says they meet the standard. The test results can be pass or fail for each test that checks the gloves resistance to microorganisms.

  Test results

  Micro-organisms Bacteria & Fungi

  EN 374-5:2016 specifies the requirements and test methods for protective gloves intended to protect against bacteria and fungi. The designation 'Bacteria & Fungi' indicates that the gloves have been tested and verified to provide effective barrier protection against microbial agents. The testing involves evaluating the glove's material and seams for their impermeability to microorganisms under conditions that simulate real-world use, ensuring no penetration occurs through the glove material or at the seams. Gloves certified under this standard are crucial for use in environments such as healthcare, laboratory settings, and any applications where preventing the transmission of infectious agents is essential. They help ensure the safety and hygiene of workers by providing reliable protection against the risks of bacterial and fungal contamination.

  Micro-organisms Virus

  EN 374-5:2016 is a standard that outlines the requirements and testing methods for protective gloves designed to protect against viruses. The designation 'Virus' indicates that the gloves have passed specific tests confirming their barrier effectiveness against viruses. These tests involve assessing the glove material's resistance to penetration by blood-borne pathogens and other virus-containing fluids, using a bacteriophage as a surrogate virus due to its small size and resistance. Gloves that meet this standard are vital in healthcare settings, laboratories, and any environment where there is a risk of exposure to viral infections. They are crucial for preventing the transmission of diseases, ensuring that workers are protected when handling potentially infectious materials, thus enhancing safety and health protocols in workplaces with biological hazards.

• EN 455-4

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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.

• 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.

• MD Label

  MD stands for "Medical Device." It refers to any instruments, apparatus, machines, implants, or other similar or related articles that are intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability. In Europe, a MD Label is a special label that must be on all Medical Devices that are sold or used in the European Union (EU). The label must include information about the product, such as the name of the manufacturer, the intended use of the product and CE mark. To be able to sell or use a Medical Device in the EU, the device must meet certain standards and requirements set by the European Union and notified body.

• PPE Category 3

  PPE stands for "personal protective equipment." PPE Category 3 refers to equipment that is complex and provide the highest level of protection such as powered respirators, SCBA, and full body suits. In Europe, PPE Category 3 must meet certain safety standards set by the European Union, which means that it must be designed and manufactured to protect the user without causing harm. Companies that make or sell PPE must prove that it meets these standards. They also must have a quality management system in place, have to be audited regularly by a notified body and have to have a technical documentation.