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Evaluation of Plasticisers for PVC for Medical Devices ForewordIt is experienced that it is extremely complicated to find alternative materials to polyvinylchloride in general and in Medical device applications particularly. In Denmark Medical Devices are pointed out as a field of high priority requiring a particular effort to substitute phthalates as plasticising agents. Medical Devices are a field of high priority, because the phthalates are able to migrate from the plastic, and unwanted biological and environmental properties are suspected. A number of national and international industrial development programmes on Plasticisers alternative to phthalates - particularly di(2-ethylhexyl)-phthalate - have been and are being conducted. In 1998 a Danish/British/Italian Brite-EuRam research project on development, evaluation and validation of Plasticisers for use in flexible PVC Medical device applications was proposed but rejected. However, the Danish Environmental Protection Agency decided to support the first two tasks of this original project. This work is presented in this report. The objective of this project is to select and evaluate non-phthalate Plasticisers for PVC for Medical Devices. The project partners are Maersk Medical A/S, Totax Plastic A/S and Danish Technological Institute, Centre for Plastics Technology. Subsuppliers are Hydro Polymers Limited, Laporte Performance Chemicals UK Ltd. and University of Strathclyde, Bioengineering Unit. From the beginning of the work the working group consisted of Maersk Medical A/S, Totax Plastic A/S, Danish Technological Institute, Papyro-Tex A/S (a subsidiary of Maersk Medical A/S) and Hydro Polymers Limited. The working group was in current contact with Laporte Performance Chemicals, who later on was included in the project group particularly during the collection of information on commercially available Plasticisers and the selection of substances to be included in the test program. Furthermore, the PVC Information Council Denmark (PVC Informationsrådet) has been represented at most of the working group meetings. The below-mentioned experts have worked in the project: Karen Marie Andersen, Papyro-Tex A/S A reference group has been formed with the above mentioned persons and those mentioned below as members: Lea Frimann Hansen, Danish Environmental Protection Agency, chairman
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