Standards and labels

• EN ISO 811:2018

  EN ISO 811:2018 is a standard that specifies the requirements and test methods for the measurement of surface wetting properties of a coating. It defines the test methods used to evaluate the ability of a coating to spread out and wet the surface it is applied on. It also specifies the performance requirements for the surface wetting properties of a coating. Possible test results include measurements of the wetting rate, wetting angle, and the contact angle of the coating. These test results help to determine the ability of a coating to wet the surface it is applied to, which is important for ensuring the coating will perform as expected.

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• 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 ISO 9001:2015

  Test results

  Service Reliability Passed

  EN ISO 9001:2015 is a globally recognized standard that specifies requirements for a quality management system (QMS), focusing on numerous aspects of quality management in organizations, aiming to enhance customer satisfaction through the effective application of the system. The 'Service Reliability' with a 'Passed' designation indicates that an organization has successfully demonstrated its ability to consistently provide services that meet customer and regulatory requirements while aiming for continual improvement. This assessment involves evaluating various elements of the QMS including service planning, execution, and monitoring, to ensure reliability and performance consistency. The practical implications for organizations that pass this aspect of the standard are significant; it establishes them as reliable providers in their industry, enhancing customer trust and satisfaction, and potentially leading to increased business and a competitive advantage.

• EN ISO 11737-1:2018/A1:2021

  EN ISO 11737-1:2018/A1:2021 is a standard that defines how to test the sterilization of medical devices. It includes requirements for the methods used to sterilize the device and how to test to make sure the sterilization process was successful. Test results should show that the device is free from harmful microorganisms and safe for use. It was amended in 2021 which is why it has A1 at the end of the name.

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• EN 13688:2013/A1:2021

  EN 13688:2013/A1:2021 is an amendment to the European standard EN 13688:2013 that specifies the performance requirements for protective clothing. The standard includes requirements for safety, comfort, and durability, as well as tests for determining these properties. Protective clothing includes items like coveralls, aprons, and gloves that are worn to protect the wearer from hazards. The amendment updates the standard to include new test methods and performance requirements. Possible test results include resistance to chemicals, heat, abrasion and tearing, as well as breathability and comfort. The clothing can be tested under different conditions to check if it meets the standard's requirements.

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• EN ISO 12947-2:1998

  EN ISO 12947-2:1998 is a standard for measuring and evaluating the colorfastness of textiles. It establishes methods for testing colorfastness to light, washing, perspiration, and rubbing. The performance requirements for textiles to pass the test include resistance to fading, change in color, and staining. Possible test results include a grade from 1-5, with 1 indicating poor colorfastness and 5 indicating excellent colorfastness.

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• EN ISO 3071:2020

  EN ISO 3071:2020 is a standard that outlines the requirements and test methods for the measurement of the thickness of flexible and semi-flexible coatings, it's an updated version of EN ISO 3071:2006. It specifies the minimum performance requirements for thickness measurement, including methods for measuring the thickness of the coating, and test methods to evaluate this measurement. The standard is used to ensure consistency in the thickness measurement of coatings used in manufacturing and other industries. It also covers the standard for evaluating the thickness of coatings applied on flexible and semi-flexible materials such as paper, textile, plastics and other materials. The standard provides a method for measuring the thickness of the coating, such as the average thickness, maximum thickness and other parameters. It also includes new definitions, test methods and requirements for the measurement of the thickness of various types of coatings applied on different substrates.

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• PPE Category 1

  PPE stands for "personal protective equipment." PPE Category 1 refers to equipment that is simple and easy to use, and has a lower level of risk. Examples of PPE Category 1 include gloves, goggles, and simple respirators. In Europe, PPE Category 1 must meet certain safety standards set by the European Union. This 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.

• 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.