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 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 B

• EN 455-1:2020

  EN 455-1:2020 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for freedom from holes, tensile strength, elongation, packaging, freedom from powder, freedom from protein, freedom from endotoxins, and freedom from pyrogens. Test results can include measurements of the gloves' freedom from holes, tensile strength, elongation, packaging, freedom from powder, freedom from protein, freedom from endotoxins and freedom from pyrogens. This version of the standard includes some changes and updates from the 2000 version.

  Test results

  Tightness AQL #,##

  EN 455-1:2020 sets the standards for medical gloves for single use, focusing on freedom from holes and ensuring glove integrity. The 'Tightness' test result, indicated by an Acceptable Quality Level (AQL) value, measures the quality level acceptable for the pinhole rate in glove batches. A lower AQL value, such as 1.5, typically used in medical settings, signifies a higher level of quality control where fewer gloves with defects are allowed. The testing for this standard involves randomly selecting gloves from a batch and filling them with water to check for leaks. Gloves that pass this test at a certain AQL value are deemed safe for use in medical and surgical procedures, where maintaining a sterile environment is crucial to prevent contamination and infection. This certification ensures that users can rely on the protective barrier of the gloves against pathogens and other contaminants.

• EN 455-4

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• 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 455-3

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• EN 455-2:2015

  EN 455-2:2015 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for physical properties, dimensions, packaging, freedom from holes, freedom from powder, freedom from protein, freedom from endotoxins, and freedom from pyrogens. Test results can include measurements of the gloves' physical properties, dimensions, packaging, freedom from holes, freedom from powder, freedom from protein, freedom from endotoxins, and freedom from pyrogens. This version of the standard includes some changes and updates from the 2009 version.

  Test results

  Physical Properties Tested

  The EN 455-2:2015 standard pertains to the physical properties of medical gloves, primarily focusing on ensuring they meet required levels of durability and performance under typical usage conditions. The designation that the physical properties were Tested under this standard implies that the gloves have undergone specific testing protocols to measure their tensile strength and elasticity and have been found compliant with predefined standards. The test method for physical properties under EN 455-2:2015 involves simulating conditions to mimic normal use and stresses that gloves would experience, such as stretching, which reveals both the elasticity and tensile strength of the material. Gloves undergoing these tests are stretched until they can stretch no further without breaking, and these results indicate whether the gloves are suitable for practical use in medical environments, offering users confidence in the durability and integrity of the gloves under operational conditions.

• 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 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

• 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.