20-Bio-A1 Biomaterials and Biocompatibility: December 2014

Paper format: National Exams, December 2014 — 04-Bio-A1 Biomaterials and Biocompatibility. Three hours, open book, any non-communicating calculator. Seven questions of equal value (20 marks each, 100 marks total); five constitute a complete paper and only the first five appearing in the answer book are marked. All seven are solved here, because this set is a study resource rather than an examination script. Every question is qualitative/descriptive (materials selection, surface science, host response) rather than numerical, except Question 7, which asks for an engineering interpretation of a small stress–strain data set — that question therefore quotes and reasons from the given numbers while still answering in flowing prose, as the question itself calls for discussion rather than a computed final answer.

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. — ch. on biomaterial classes (polymers, metals, ceramics), ch. on surface characterization (XPS, contact angle), ch. on the host response to biomaterials, ch. on cardiovascular and orthopedic device applications.
• ISO 10993 (all relevant parts), Biological evaluation of medical devices — the standard biocompatibility test framework referenced throughout.
• J. Enderle & J. Bronzino, Introduction to Biomedical Engineering, 4th ed. — supporting chapter on biomaterials and tissue engineering.
• Health Canada Medical Devices Regulations (SOR/98-282); FDA 21 CFR 820 — regulatory frame for materials-related device approval referenced in the design-criteria discussions below.

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