Standards and labels

• EN 374-1

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• EN 374-5

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• EN 374-2

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• 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.

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  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 455-3

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• EN 455-2

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• EN 455-1

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• EN 455-4

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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.

• ISO 14001:2015

  ISO 14001:2015 is a standard that specifies requirements for an environmental management system (EMS). It includes requirements for how companies should design, implement, maintain and improve their EMS to ensure that they minimize negative impacts on the environment and comply with environmental regulations. Test results can include information on how well the EMS is functioning, how well it is being followed, and how effective it is in reducing environmental impacts. The standard also includes requirements for how the company should document and record their EMS performance and continuously improve it.

  Test results

  Environmental Management Passed

  The standard ISO 14001:2015 pertains to environmental management systems (EMS). A passed test result under this standard indicates that an organization's EMS meets the stringent criteria set forth for managing environmental responsibilities systematically. This ensures sustainable development while considering environmental impacts. Specifically, ISO 14001:2015 includes requirements for a framework that an organization can follow rather than establishing environmental performance criteria. It encompasses various aspects such as compliance obligations, planning actions to address risks and opportunities, and continual improvement. The test primarily involves evaluating the effectiveness of the EMS in supporting a company to achieve its intended outcomes regarding its environmental performance. If a company has passed this evaluation, it reflects their commitment to environmental stewardship, potentially enhancing their marketability and aiding in compliance with statutory and regulatory requirements.

• EN ISO 14971:2019

  EN ISO 14971:2019 is an international standard for medical device risk management. It provides a framework for identifying, assessing, and controlling risks associated with medical devices. The standard requires that medical device manufacturers establish a risk management process and provide documentation of this process. The performance requirements include risk analysis, risk evaluation, and risk control. Possible test results include determining that the medical device is safe to use and that the risk management process is adequate.

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• 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 20417:2021

  EN ISO 20417:2021 is an international standard that defines the requirements and test methods for safety and performance of electric footwarmers. This standard covers the safety, mechanical, electrical, and performance requirements for footwarmers, including thermal performance, power consumption, and temperature control. The standard also includes test methods for determining compliance with the requirements, such as temperature measurement and electrical safety testing. The test results show that the product meets the safety and performance requirements of the standard.

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• ISO 15223-1

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• EN 374-4

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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.

  Test results

  General Requirements Guide

• REACH

  REACH stands for "Registration, Evaluation, Authorisation and Restriction of Chemicals" it is a regulation of the European Union that governs the registration, evaluation, authorization, and restriction of chemicals. The REACH regulation aims to ensure that the chemicals used in Europe are safe for human health and the environment. The regulation applies to all chemical substances, whether they are used in industrial processes or in everyday products such as cleaning products, paints, and cosmetics. Companies that manufacture, import or use chemicals in the EU must register the chemicals they produce or import, provide safety information and communicate the risks associated with the chemicals. This information will be used to assess the risks and determine if any further action is needed to protect human health and the environment.

• 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.