Amoena manufactures its products in compliance with applicable regulatory requirements, in accordance to to ISO 13485 for medical devices. The standard guarantees high product quality and safety for users. Amoena breast forms are made of two materials that are soft on the skin: Silicone and PU (Polyurethane) film.
Silicone is produced synthetically from the natural raw materials sand and carbon. It offers various advantages: silicone is kind to the skin, soft, water-repellent and very resistant to chemicals and heat. This means that breast forms adapt quickly to the body temperature. Amoena develops and formulates all of its own silicone gel. It is mixed from silicone raw materials and the quality is carefully tested. The name PU-film refers to an extremely durable and high performance film that is very similar to skin in its softness and flexibility. Biocompatibility tests according to ISO 10993, have shown that the film does not cause allergic reactions or skin irritation. With this ultra-thin and durable film, the silicone breast form is very kind to the skin and body. All Amoena products, whether self-adhesive, particularly soft or weight-reducing, are covered with a SuperSoft film. This finely structured film has a natural silky appearance and is extremely flexible and soft.