Biocompatible plastic material

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. 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. 

Biocompatibility approach

Ensinger subjects its medical materials (MT semi finished products) 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 regular combined tests on biocompatbility:

  • Cytotoxicity/growth inhibition (ISO 10993-5)
  • Haemolysis (ISO 10993-4)
  • Chemical analysis/"fingerprinting" (ISO 10993-18) 
  • Biological-toxicological evaluation (ISO 10993-1) 

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.

Certificates of biocompatibility

All semi finished stock items for medical use (MT portfolio) have been tested for biocompatibility according to ISO 10993. Certificates of biocompatibility are provided with every order for Ensinger MT plastics. They include not only the raw material conformity, but also the examination results of the semi finished product in accordance with ISO 10993. With the order related issuing, we ensure seamless traceability from the customer's order for the semi finished product and the raw material used.

When issuing order specific certificates for biocompatible plastics, Ensinger indicates additional tests which have also been performed on the relevant raw material. 

These can vary depending on the raw material concerned and are always checked for their topicality and validity on our suppliers' premises, on the basis of the Ensinger compliance management system.

Benefits

Using a biocompatible Ensinger medical grade material offers peace of mind that the right physiologically harmless material has been chosen at an early stage of product development, saving time and cutting costs.

The biocompatibility certificate provided by Ensinger includes all risk evaluation information necessary, thus supporting a lean evaluation process for medical devices. 

The certificate also secures traceability, which offers a cost effective documentation process.

Biocompatible Medical grade plastics (MT materials)

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 are biocompatible according to ISO 10993-1,-4,-5,-18: