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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 14126

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• EN ISO 22610:2006

  EN ISO 22610:2006 is a standard that sets the requirements for the performance and testing of clothing for protection against heat and flame. The standard defines the requirements for materials, design, and test methods for clothing worn to protect against heat and flame, to ensure that the clothing provides adequate protection in the event of an emergency. Test results will include information on the materials' ability to withstand heat and flame and the amount of time the clothing will provide protection. The standard is intended to ensure that clothing provides adequate protection against heat and flame in the workplace.

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• EN ISO 22612:2005

  EN ISO 22612:2005 is a standard that sets the requirements for the performance and testing of gloves against chemicals. The standard defines the requirements for materials, design, and test methods for gloves worn to protect against chemicals, to ensure that the gloves provide adequate protection. Test results will include information on the materials' resistance to permeation, degradation, and penetration by chemicals. The standard is intended to ensure that gloves provide adequate protection against chemicals in the workplace.

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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.