By definition, semi finished products are not medical or pharmaceutical products, but pre-products used for their production. As there is consequently no standardised requirement to evaluate the biological suitability of semi finished products and biocompatibility of polymers, Ensinger has made its own selection from the wide spectrum of different biocompatibility tests contained in ISO 10993 and USP Class VI. This is intended to provide our customers with the greatest possible assistance with the risk evaluation and approval process for their medical or pharmaceutical end products using biocompatible polymers.
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 followingcombined 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.
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.
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 less than 24 hrs. according to ISO 10993:
