Kunststoffe in der Medizintechnik (Medical grade plastics)
Thomas Seul, Stefan Roth, Carl Hanser Verlag, Munich, Germany, 2020, 216 p., hardcover, EUR 99,99, ISBN 978-3-446-45553-5 (hard copy) / EUR 79,99, ISBN 978-3-446-44964-0 (E-book)
It is an exception that we present here books which are available in German language only. This new book makes an exception as it is an extremely useful and up-to-date compilation of all relevant aspects of plastics in medical engineering. The full German title is Kunststoffe in der Medizintechnik. Vorschriften und Regularien, Produktrealisierung, Herstellungsprozesse, Qualifizierungs- und Validierungsstrategien.
It is almost impossible to imagine medical products without plastics: whether as packaging material, as material for medical disposables such as syringes and catheters, or for prostheses and even implants such as artificial hip joints. Plastics enable high-performance and at the same time affordable medical products and thus provide the population with broad access to medical care, because plastics can be used to produce a wide range of properties while at the same time being very well tolerated by the body. The book is designed as a guideline for the use of plastics in medical devices. It addresses employees from all areas of medical technology such as product and process development, production, quality management and purchasing. In a clear and easy-to-understand manner, the various subject areas arising from the use of plastics for this application are addressed and explained. With a presentation of the market and an explanation of the regulatory requirements for medical devices, the book introduces this area and shows the resulting requirements for plastics in medical technology. Particularly specific topics such as the procedure for assessing biocompatibility and the sterilisation of plastics are addressed and explained. In a further step, the basic procedure for the development and validation of medical devices and the associated processes is described. Relevant processes such as injection moulding and the associated approaches for a qualification of plants, systems and tools as well as process validation but also the handling of further processing methods such as joining technologies in conformity with the guidelines are addressed. For the first time, additive manufacturing is also being examined with regard to its use in medical technology. Practical application examples and an introduction to the most common plastics used in medical products and their specific properties in this field, such as sterilisability or processing, round off the work. It is particularly worth mentioning that the book is currently up to date, as the amended Medical Devices Regulation 2017/745 has already been fully taken into account.
Prof. Dr. Thomas Seul is Prorector - Research and Transfer at Schmalkalden University of Applied Sciences. In the Faculty of Mechanical Engineering, he represents in particular the teaching and research activities in the Applied Plastics Engineering course. He is also President of the Association of German Tool and Mould Makers. Prof. Dr.-Ing. Stefan Roth is chairman of the working group Plastics in Medical Technology of the Association of German Engineers (VDI) and played a leading role in designing the VDI guideline 2017 Medical Grade Plastics. Roth is professor at the Faculty of Mechanical Engineering at Schmalkalden University of Applied Sciences. Before he worked in industry for ten years in various positions in medical technology at B. Braun Melsungen AG, most recently in project management.