Paper format: National Exams, May 2013 — 04-Bio-B5 Cell and Tissue Engineering (the exam's own header). Three hours, open book, any Casio/Sharp non-communicating calculator. Six questions of equal value (20 marks each, 120 marks printed); five constitute a complete paper and only the first five appearing in the answer book are marked (100 marks total). All six are solved here, because this set is a study resource rather than an examination script. Every question is essay/descriptive (design, regulatory, and mechanistic reasoning in tissue engineering) with no numerical data to compute — the marking-scheme arithmetic is the only concrete number in the paper.
Reference texts (the books an open-book candidate should have on the desk for this subject):
- R. Lanza, R. Langer & J. Vacanti (eds.), Principles of Tissue Engineering, 5th ed. — chs. on scaffold design and biomaterials for TE, bioartificial liver and kidney devices, the foreign body response to implanted constructs, cell sourcing (stem cells, gene-modified cells), and regulatory pathways for tissue-engineered products.
- 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 the host response to biomaterials (acute/chronic inflammation, foreign body giant cells, fibrous encapsulation).
- ISO 10993 (all relevant parts), Biological evaluation of medical devices — the biocompatibility test framework referenced in Questions 2(b) and 5.
- Health Canada Medical Devices Regulations (SOR/98-282) and Health Canada guidance on cell, tissue, and organ (CTO) and combination products — the Canadian regulatory frame for Question 5.
