Biocompatibility testing for medical grade (MT) semi-finished products
In medical technology, the requirements for quality and documentation of products and their and their approvals are very high. Pre-tested semi-finished materials facilitate our customers the approval of their own medical technology products. Our MT semi-finished products have been tested or evaluated for biocompatibility in accordance with standard ISO 10993-1, -4, -5, -18 and meet the specified requirements for contact of up to 24 hours with skin and tissue and, if necessary, indirect contact with blood.
For the stock shapes within the Ensinger MED- / MT-standard-portfolio, a biocompatibility declaration is supplied on an order-related basis. This includes the results of the biocompatibility tests that were performed on the stock shapes and, if applicable, additional information on conformities that are available for the raw materials used. The order-related declaration also serves to provide consistent and for our customers comprehensible traceability of the customer order with regard to the products and the raw materials used.