20-Bio-A1 Biomaterials and Biocompatibility: December 2016

Paper format: National Exams, December 2016 — 04-Bio-A1 Biomaterials and Biocompatibility. Three hours, open book, any non-communicating calculator. Six questions of equal value (20 marks each, 100 marks total for a complete paper); five constitute a complete exam paper and only the first five appearing in the answer book are marked. All six are solved here, because this set is a study resource rather than an examination script. Most questions require an essay-format answer (materials selection, host response, surface/mechanical characterization); Question 6 additionally asks for an engineering interpretation of a small stress–strain data set, so it quotes and reasons from descriptive statistics computed from the given numbers while still answering in the flowing prose the question calls for.

Reference texts (the books an open-book candidate should have on the desk for this subject):

• B. D. Ratner, A. S. Hoffman, F. J. Schoen & J. E. Lemons (eds.), Biomaterials Science: An Introduction to Materials in Medicine, 4th ed. — chs. on biomaterial classes (polymers, metals, ceramics), tissue engineering scaffolds, the host response to biomaterials, cardiovascular/blood–material interactions, orthopedic biomaterials, and mechanical properties of biomaterials.
• ISO 10993 (all relevant parts), Biological evaluation of medical devices — the standard biocompatibility test framework referenced throughout, including the local-effects (-6), cytotoxicity (-5), and haemocompatibility (-4) parts.
• J. Enderle & J. Bronzino, Introduction to Biomedical Engineering, 4th ed. — supporting chapters on biomaterials, tissue engineering, and cardiovascular devices.
• Health Canada Medical Devices Regulations (SOR/98-282); FDA 21 CFR 820 — the regulatory frame for a novel combination-product device referenced in Question 1.

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