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e1
QUESTIONS
1. Why is the in vivo assessment of a medical device
carried out?
2. What biomaterial components and characteristics
may affect the overall biological responses of a medi-
cal device?
6. Several different types of biocompatibility tests uti-
lize histological assessment techniques to determine
biological response parameters. Identify four biolog-
ical response parameters.
7. What healing process in vascular grafts is found
with all animal and nonhuman primates, but not in
humans?
general type of medical devices?
10. What are the components of risk related to inade-
ANSWERS
1. To determine that the device performs as intended,
and presents no significant harm to the patient or
5. Carcinogenicity or tumor formation.
6. See Table II.3.4.4.
7. Endothelialization.
8. a. Accelerated calcification
b. Thrombosis.
b. Assessment of the exposure (duration of implant
and expected timing of complications); and
c. Probability and consequences of an adverse effect
(frequency, outcome, patient factors, cost).
11. a. Application of the biomaterials may be different
than originally tested;
b. Fabrication changes and interactions between
TRUE/FALSE
1. A biomaterial considered compatible for one applica-
be tested in the final product form and/or end-use appli-
cation. (True)
4. Carcinogenicity testing of a biomaterial in a medical
device may not be necessary. (True)
CHAPTER II.3.4
In Vivo Assessment of Tissue Compatibility
