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.

  Test results

  Medical Management Passed

  The ISO 13485:2016 standard is specifically tailored for medical device manufacturers and aims to ensure the quality and safety of medical devices throughout their production and lifecycle. A test result of Passed in the context of the ISO 13485:2016 standard signifies that the medical device manufacturing management system under assessment has successfully met all regulatory and safety requirements stipulated in the standard. This encompasses rigorous evaluations of the manufacturer's quality management system, including processes like risk management, regulatory compliance, and effective process control. The assessment involves auditing processes such as document review, facility inspection, and staff interviews, to verify the adequacy and effectiveness of the quality management system. Meeting the ISO 13485:2016 requirements assists manufacturers in achieving and maintaining regulatory compliance and ensures that their products consistently meet user needs and applicable regulatory standards, which is crucial for entry and continued presence in global markets.

• 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/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.

  Test results

  Specified Requirements Type B

• 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 21420:2020

  EN ISO 21420:2020 is a European standard that sets out the general requirements for hand protection, including comfort, fit, and dexterity.

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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.

  Test results

  Service Reliability Passed

• 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.

  Test results

  Permeation Contact Tested

  EN 16523-1:2015+A1:2018 provides the methodology for determining the resistance of materials used in protective clothing to permeation by chemicals under continuous contact. The designation 'Tested' signifies that the material has been evaluated for its ability to prevent chemical penetration over a specified duration and under certain conditions. The test method involves placing the test chemical in contact with the material and measuring the rate at which the chemical passes through to the other side, simulating exposure scenarios where chemicals might come into continuous contact with the protective gear. Materials that have undergone this testing are crucial for industries such as chemical manufacturing, healthcare, and laboratory work, where workers are exposed to hazardous substances. This certification ensures that the protective clothing provides a reliable barrier against chemical risks, enhancing safety and compliance with health and safety regulations.

• 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 374-2:2014

  EN 374-2:2014 is a European standard that defines the performance requirements and test methods for chemical protective gloves against microorganisms. It specifies the minimum requirements for gloves to protect against microorganisms. The standard includes test methods for resistance to penetration by microorganisms and possible test results include pass/fail for each requirement.

  Test results

  Penetration Resistance Tested

  EN 374-2:2014 is an European Standard that specifies the requirements and test methods for evaluating the resistance of gloves to penetration by chemicals and/or microorganisms. In the test a glove is assessed for its capacity to resist penetration by micro-organisms or chemicals through pores, pinholes, or other imperfections. The test method involves inflating the glove with air or filling it with water and then examining it for leaks. This standard is important for ensuring that protective gloves do not allow harmful substances to reach the skin, thereby providing safety in chemical and biological environments.

• 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.

• 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.