Gail Baura, "Medical Device Technologies: A Systems Based Overview Using Engineering Standards"
English | ISBN: 012374976X | 2012 | 512 pages | PDF | 26 MB
The goal of this textbook is to provide undergraduate engineering students with an introduction to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining 8 chapters are medical device laboratory experiment chapters.
Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach enables students to quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI).
The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas
Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters
Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature
Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts
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