By Andrés Díaz Lantada
The final a long time have obvious notable advances in computer‐aided layout, engineering and production applied sciences, multi‐variable simulation instruments, scientific imaging, biomimetic layout, speedy prototyping, micro and nanomanufacturing tools and data administration assets, all of which supply new horizons for the Biomedical Engineering fields and the clinical equipment undefined. complicated layout and production applied sciences for Biomedical units covers such themes extensive, with an utilized point of view and supplying numerous case reports that aid to investigate and comprehend the main components of different phases associated with the improvement of a singular biomedical machine, from the conceptual and layout steps, to the prototyping and industrialization levels. major learn demanding situations and destiny potentials also are mentioned, bearing in mind appropriate social calls for and a transforming into marketplace already exceeding billions of bucks. In time, complicated biomedical units will decisively switch tools and leads to the clinical global, dramatically bettering diagnoses and treatments for all types of pathologies. but when those biodevices are to satisfy current expectancies, today’s engineers want a thorough grounding in similar simulation, layout and production applied sciences, and collaboration among specialists of alternative components should be promoted, as can also be analyzed inside of this handbook.
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Extra info for Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices
1. : Lehrbuch der Kinematik. Die praktischen Beziehungen Kinematik zu Geometrie und Mechanik, vol. 2. : Product Design: Fundamentals and Methods. : Product Lifecycle Management, 3rd edn. : Product Lifecycle Management: 21st Century Paradigm for Product Realisation. : Atlas ilustrado de las máquinas de Leonardo. : Konstruieren und Gestalten. : Product Design and Development, 4th edn. Mc-Graw Hill/Irwin, New York (2007) Chapter 2 General Considerations for the Development of Biomedical Devices Andrés Díaz Lantada and Pilar Lafont Morgado Abstract The development process of medical devices and of any products oriented to interacting with biological systems (biodevices) involves several special features deriving from the typical multidisciplinary characteristics of such devices and of their surrounding environment.
Bioactive materials – They have the ability to form direct chemical ties with the surrounding tissue allowing this tissue to grow freely on their surface. Some examples of these materials are high density hydroxyapatite and tricalcic phosphate. All materials used in medical device development, particularly those that will be in contact with body tissues, must meet a set of manufacturing and chemical requirements and properties and body-compatibility requirements, which are mainly mechanical. These are listed in Fig.
D. L. Morgado These alternative procedures are mandatory for sterilised devices. • As an alternative the manufacturer must receive approval of the “total quality assurance system” by a notified body, with the exception of having to apply the product design examination. For “Class II b” Devices At the manufacturer or agent’s choice, these products must obtain: • The “EC type examination” and depending on the choice: – The “EC verification” by a notified body – Approval of the “production quality system” by a notified body – Approval of the “product quality system” by a notified body • As an alternative the manufacturer must receive approval of the “total quality assurance system” by a notified body, with the exception of having to apply the product design examination.