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Standards and labels

• ISO 13485

  Medical devices with the ISO 13485 rating are tested for their manufacturer's quality management system, ensuring consistent safety and effectiveness. This means you can trust that these products are made with strict quality controls to help ensure they are safe and reliable for their intended use.

  Reach out to ask about the standard test results

• Amfori BSCI

  Amfori BSCI is a set of standards for fair and responsible business practices in the global supply chain. Companies that join Amfori BSCI commit to following these standards in their operations and supply chain. This includes things like fair wages and working conditions, safe workplaces, and protecting the environment. It is voluntary, but many companies in Europe choose to join to show their commitment to responsible business practices.

• 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.

• 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.