San Premium 7/XXL Shaped Pad

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

• EN ISO 9001:2015

  Products with the EN ISO 9001:2015 rating are tested for the company's commitment to consistent quality and customer satisfaction through its management systems. This means you can expect reliable products and a focus on meeting your needs.

  Reach out to ask about the standard test results

• ISO 14001

  Products from companies with the ISO 14001 rating are tested for how effectively the company manages its environmental impact, including waste reduction and resource efficiency. This means you can trust that the products are made by an organization committed to reducing its environmental footprint and operating sustainably.

  Reach out to ask about the standard test results

• 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.

• Nordic Swan Ecolabel

  Nordic Swan Ecolabel is a label used to indicate that a product is environmentally friendly and meets certain sustainability standards. The label is used in the Nordic countries (Denmark, Sweden, Norway, Finland and Iceland) and it is granted by the Nordic Ecolabelling, an independent organization. The standards set by the Nordic Ecolabelling are based on the EU criteria for eco-labeling and they cover a wide range of products, from cleaning products to electrical appliances. To be awarded the Nordic Swan label, products must meet strict environmental criteria and they must be produced with the aim to reduce the environmental impact.

• 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.

• 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.

• Dermatologically Tested

  Dermatologically Tested refers to products that have been tested and proven to be safe for use on the skin. The European Union has regulations for cosmetics products, which includes dermatological testing, to ensure that products are safe for use. To be labeled as dermatologically tested, the product must be tested by a qualified professional, such as a dermatologist, and must not cause any irritation or allergic reactions. The testing must be carried out on a representative sample of human volunteers and the results must be evaluated by a qualified professional before the product can be considered as dermatologically tested and can bear the label. The EU Cosmetics Regulation, lays out the specific requirements for safety assessments and labeling of cosmetics products.