San Premium 2 Bladder Protection Pad

Standards and labels

• ISO 13485:2016

  Medical devices with the ISO 13485:2016 rating are tested for a quality management system that ensures consistent safety, quality, and regulatory compliance throughout their lifecycle. This provides assurance that the product is reliably produced to high international standards for patient use.

  Test results

  Medical Management Passed

  This product was made under a quality management system that ensures consistent design, production, and distribution. This focuses on the safety, performance, and regulatory compliance of medical devices throughout their entire lifecycle, from design to disposal.

• EN ISO 9001:2015

  Products from companies with the EN ISO 9001:2015 rating are tested for the company's systems for consistently providing quality products and services and meeting customer needs. This means the company is committed to consistent quality, aiming to meet your needs and improve its offerings, leading to more reliable products and better customer experience.

  Test results

  Service Reliability Passed

  This certification shows a commitment to quality and consistency. It ensures the company's processes are managed to deliver reliable, effective service and a better customer experience from start to finish.

• ISO 14001:2015

  Products from companies with the ISO 14001:2015 rating are from organizations whose environmental management systems are verified for controlling their environmental impact, waste, and resource use. This means your purchase supports a company committed to sustainable operations and reducing its environmental footprint.

  Test results

  Environmental Management Passed

  This product comes from a manufacturer that has an internationally recognized environmental management system. This system helps the company reduce its environmental impact by improving resource efficiency, reducing waste, and managing environmental risks.

• 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.

• FSC Mix

  FSC Mix is a label that indicates that a product contains a mix of wood from both responsibly managed forests (FSC certified) and other sources. In Europe, to use the FSC Mix label, a company must ensure that the wood used in the product is from legal and responsibly managed sources. Additionally, the company must have a system in place to track the wood used in the product and be able to prove that it comes from a mix of FSC certified and other sources.

• 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.