Medical Device Legislation and Material Selection
This Course is provided to give product designers and developers an understanding of the underlying principles of medical device regulations and their requirements for medical device design and to then apply these requirements when identifying plastics materials that are suitable for use with medical devices. A detailed over view of the EU Medical Device Directive 93/42/EEC is given and the technicalities of its compliance explained. The use of polymers in medical devices is considered in terms of design and material selection. The course modules also focus on material testing requirements and look to the developments in ISO 10993 Biological Evaluation of Medical Devices where new standards are provided which allow alternatives to traditional animal testing.