a) A material alone cannot be advertised as being FDA compliant. Explain why this statement is true. b) ISO 10993 covers the biocompatibility testing of medical devices. The testing matrix from the standard is shown in Table 4 (back of paper). Using this matrix, specify the testing that would need to be carried out on a vascular stent i. ii. a simple plaster (e.g. bandaid) iii. a catheter delivery system for a vascular stent (There is no need to write out all the tests write out the category e.g. surface device-skin-a. Also include any assumptions you make within your answer.) c) Which of the following is biocompatibility testing carried out on? Finished materials not assembled into a device i. Raw materials ii. iii. iv. Sterilised raw materials Finished assembled devices Give a reason for your answer. d) Explain when a degradation test shall be performed and give an example of a device that would require degradation testing. e) Explain how you would test a material to examine the surface tension on that material. Use diagrams to illustrate your answer. f) Surface properties of materials can change after manufacturing. Explain why this is especially true for biomaterials and what can cause these changes. Give three examples. (4