Medical devices, including software and diagnostic tools, with the EN ISO 14971:2019 rating are tested for how well their potential risks are identified, evaluated, and controlled throughout their entire lifespan. This rigorous process helps ensure the product is as safe as possible for you to use, with its benefits clearly outweighing any remaining small risks.

Medical gloves with the EN 455-3:2015 rating are tested for biological safety, including protein, endotoxin, chemical, and powder content. This ensures the gloves are safe for use, reducing risks of allergic reactions and irritation for consumers.

Single-use medical gloves with the EN 455-2:2015 rating are tested for physical properties like dimensions and strength. This ensures gloves fit correctly and are strong enough to provide reliable protection without tearing during use.

Test results

Medical gloves for single use with the EN 455-1:2020+A1:2022 rating are tested for freedom from holes and leakage. This ensures the gloves provide a reliable barrier, minimizing the risk of contamination for your safety and protection.

Test results

Single-use medical gloves with the EN 455-4:2009 rating are tested for their shelf life, ensuring they maintain properties like strength and barrier integrity over time. This means the gloves will remain effective and safe, providing reliable protection against infections until their expiration date when stored correctly.

Protective gloves, mittens, and arm protectors with the EN ISO 21420:2020 rating are tested for general requirements like material safety, comfortable fit, and dexterity. This ensures the products are safe against your skin, provide a good fit, and allow for easy hand movement while you use them.

Test results

Medical devices and their accessories with the EN ISO 20417:2021 rating are tested for clear and complete information supplied by the manufacturer, covering identification, labeling, packaging, and instructions. This ensures you receive essential details to use the product safely and effectively, promoting patient safety and confidence.

Medical devices with the EN ISO 15223-1:2021 rating use standardized symbols to convey essential information from the manufacturer. This ensures you can quickly understand crucial details about the device, regardless of your language, leading to safer and more effective use.

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 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 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.