Ensinger Medical Grade (MT, MED) products in the form of, for example, compound, stock shapes or filament are intermediate products intended for further processing and therefore do not fall directly under the requirements for biological safety assessment or other standards applicable to final medical or pharmaceutical products. For plastic materials within the Ensinger MED- / MT-standard-portfolio, a specific selection is made from the multitude of biocompatibility tests that are possible according to ISO 10993 or USP Plastic Class VI (chapters <87> and <88>), which is reasonable for the stage of the preliminary products. This proves the high degree of inertness towards biological systems for the biocompatible polymers.
The safety of the patient comes first, both for the selection of physiologically safe materials as well as for the evaluation respectively testing of the biocompatible properties. Ensinger medical grade plastics are marked with the trade name abbreviation MT respectively MED for Compounds. However, the evaluation of biocompatibility can also be completely adapted to the individual product and a wide variety of customer-specific solutions are implemented.
Plastic materials within the Ensinger MED- / MT-standard-portfolio intended for use in medical technology with contact of up to 24 hours with skin and tissue and, if applicable, indirect contact with blood, are usually subjected to the following in vitro tests. The biocompatible materials meet the requirements specified in the respective biocompatibility test. This is intended to provide our customers with the best possible support in the process of risk assessment and approval for their own finished medical devices or pharmaceutical applications.
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.
With our Medical Grade Filament portfolio, we offer biocompatible filaments that have been produced according to ISO 13485 and tested or evaluated for biocompatibility according to 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 applicable, indirect contact with blood.
Our in-house production of medical fibre composites allows maximum flexibility and full traceability of materials and components. This ensures a high level of safety, transparency and quality and allows us to provide you with comprehensive advice on your project.
The evaluation of biocompatibility can also be completely adapted to the customer's individual needs. Find out more about our process technologies for medical parts.
