Evaluation of Plasticisers for PVC for Medical Devices

Summary and conclusions

On the basis of a feasibility study of the plasticiser substances and groups of substances that are commercially available on the market today, nine substances were selected for further investigations. PVC compounds plasticised with these selected substances were prepared and tested for a number of properties that were considered as primary selection criteria for Medical applications. Compounding was easy with all the investigated plasticising substances and it was easy to prepare specimens and test samples by injection moulding with all the prepared compounds. An attempt was made to rank the selected and investigated substances in comparison with a reference DEHP plasticised PVC compound. Some have a slightly lower strength value, some have a slightly lower strain at break value, and some have a higher cold flexibility temperature. None of the substances was rejected as potential alternatives to DEHP. However, much more data are needed before DEHP can be seriously substituted in Medical Devices.