Ensinger generally subjects its medical materials (MT semi finished plastics) intended for use in medical products, which are suitable for a contact period of 24 h with skin and tissue, and, where applicable, indirect contact with blood, to the following combined tests on biocompatibility:
With this approach, Ensinger is following the recommendations of ISO 10993-1 with respect to step by step biological qualification.
By means of in vitro tests for cytotoxicity (ISO 10993-5) and haemolysis (ISO 10993-4), steps are taken to ensure that the products demonstrate sufficiently inert properties in contact with blood and tissue and have a defined toxicological profile. In this process, the cytotoxicity/growth inhibition test, which is regarded as the standard test and basic biological test for all medical products, represents the basis for toxicological evaluation of the material.
All semi finished stock items for medical use (MT portfolio) fulfill the requirements on biocompatibility for their specified application with <24 h contact. Declarations of biocompatibility are provided with every order for Ensinger MT plastics. They include generally not only the raw material conformity such as e.g. ISO 10993 or USP Class VI, but also the examination results of the semi finished product in accordance with ISO 10993. With the order related issuing, we ensure traceability from the customer's order for the semi finished product and the raw material used.
The Ensinger Medical Grade (MT) semi finished plastics offer a high degree of inertness related to the biological system. This can be proven by suitable biocompatibility testings and additional information on raw materials. These information shorten the time consuming process for collecting data in the downstream value chain. Depending on the specific application, test results on biocompatibility on semi finished plastics and raw materials might be transferred on downstream products to safe cost and time.
The biocompatibility declaration provided by Ensinger includes extensive data necessary, thus supporting a lean evaluation process for medical devices. The certificate also secures traceability, which offers a cost effective documentation process.
Using a biocompatible Ensinger medical grade material offers peace of mind that the right material has been chosen at an early stage of product development.
Ensinger offers medical grade materials (MT) for a wide range of different engineering and high performance plastics. This allows our customers to select the most suitable material for their application and devices without a restrictive filter limiting the selection.
The following Ensinger medical grade materials fulfill the biocompatible requirements for specified applications with contact <24 h according to ISO 10993:
