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Evaluation of Plasticisers for PVC for Medical Devices 1 ObjectiveThe objective of this project is to select and evaluate Plasticisers for PVC for Medical Devices using DEHP as a benchmark. The selection has been carried out on the basis of commercially available Plasticisers that are presumed to be suitable for use as primary Plasticisers with PVC materials used for Medical Devices. The substances have been selected and evaluated as regards the requirements defined for Medical films and tubings. No new Plasticisers have been developed. However, considerations have also been given to other substances (e.g. polymeric substances) on the market, which might be suitable as Plasticisers for PVC for Medical applications. On the basis of the results of testing conducted in the project an attempt has been made to rank the investigated Plasticisers and PVC compounds according to their probability for success for use in Medical device applications. It is the intention of the project partners in a subsequent project for further investigations to be able to continue with the manufacture and testing of specific Medical Devices (e.g. catheters and drainage bags) made from the most promising compounds.
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