Amoena manufactures its products under strict conditions, in accordance with ISO 13485 for medical devices. This 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 natural raw materials: sand and carbon. It offers various advantages: Silicone is gentle to the skin, soft, water-repellent and very resistant to chemicals and heat. This means that breast forms adapt quickly to body temperature. Amoena develops and formulates all of its own silicone gel. It is mixed from raw materials and the quality is carefully tested. The phrase “PU film” refers to an extremely durable and high performance film that is very similar to skin in its softness and flexibility – this surrounds the silicone. 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 gentle enough for the skin and body. All Amoena products, whether self-adhesive, particularly soft or lightweight, are covered with a SuperSoft PU film. This finely structured film has a natural, silky appearance and is extremely flexible and soft.