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Introduction To Biomedical Engineering

Instructions:

Answer 50 questions in 15 minutes.
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Match each statement with the correct term.
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This is a study tool. The 3 wrong answers for each question are randomly chosen from answers to other questions. So, you might find at times the answers obvious, but you will see it re-enforces your understanding as you take the test each time.

1. Investigator
rough ER
Intracellular
informed consent
human subject research procedure 1

2. Because the devices may not state that they FDA- approved

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3. Blood pressure cuffs - venipuncture materials (IVs - drawing blood - infusion pumps) - powered wheelchairs - surgical drapes
plasma membrane acts
class III 510(k) requiring examples
class II examples
biodegradable materials have

4. No significant risk; all are exempt from needing FDA registration
distal
mean arterial pressure
therapeutic experiment
class I

5. Number of subjects - safety assurances - privacy protection - informed consent documents
IRB review areas (4)
two ways larger molecules pass through cell membrane
superior
during external respiration -

6. Trial of artificial kidneys
class I examples
anterior view
therapeutic experiment example 2
investigator

7. Clinical trial of new chemotherapy drug
pronation
why IDE's are common
therapeutic experiment example 1
lateral

8. Hollow - cylindrical structures that aid in cell division by transporting chromosomes
microtubules
510(k) must prove this
class III
distal

9. Mitosis
IRB review areas (4)
passive transport
inferior
m - cell cycle

10. Genotyping to determine risk factors for disease
non - therapeutic experiment example 2
frontal plane
non - therapeutic experiment
stress - s

11. Premarket approval - Are licenses to an individual company to market a specific device - require a lot of time and money to prove safety and effectiveness
therapeutic experiment example 1
how IDE's can be granted
PMA
class III examples

12. Stiff and brittle - good insulators of heat and electricity - very high melting point - hard - wear resistant
ceramics are (5)
What a PDP - sponsor and FDA agree on
larger molecules require
therapeutic experiment

13. One which has direct benefit to the patient
why 510(k)'s standard for clearance is lower
IRB review areas (4)
larger molecules require
therapeutic experiment

14. 'substantial equivalence' to another approved and safe device to technology currently on the market
510(k) must prove this
extension
investigator
a 'biodegradable' product has the ability to break down

15. F/ A0
coronary arteries
stress - s
degradation steps
Lower ion concentration of K

16. Institutional review board - consider the ethical aspects - to evaluate - approve - and monitor proposals to perform human research
posterior view
if the stroke volume is less than this
adduction
IRB

17. Divides the body in left and right halves; aka median plane
pulse pressure
superior
a completed PDP
midsagittal plane

18. Provide additional knowledge without direct benefit to the patient
tumor suppressor gene
two ways larger molecules pass through cell membrane
posterior view
non - therapeutic experiment

19. Back view (palms up)
posterior view
heart failure
competence - informed consent
if the stroke volume is less than this

20. Systolic pressure - diastolic pressure
age - informed consent
pulse pressure
cardiac output
510(k) must prove this

21. Flexible - light - can be translucent or not transparent - can be degradable or stable - easy to work with - inexpensive
non - therapeutic experiment
class II
polymers (5)
cardiac output

22. Front view (palms up)
healing response
residual volume =
PMA
anterior view

23. Programmed cell death
Lower ion concentration of K
Hooke's law - s
apoptosis
Intracellular

24. Three classes
larger molecules require
device classification has
peripheral nervous system
a 'biodegradable' product has the ability to break down

25. Involves carries - channels - or direct diffusion from high concentration to low concentration
why 510(k)'s standard for clearance is lower
degradation steps
passive transport
s - cell cycle

26. Growth phase 2
g2 - cell cycle
peripheral nervous system
small molecules
classes of biomaterials (4)

27. Replacement heart valves - stents - breast implants
two ways larger molecules pass through cell membrane
plasma membrane acts
active transport
class III examples

28. lower ion concentration of Na
human subject research procedure 4
the protocol for human subject research
Intracellular
PMA

29. Total lung capacity - vital capacity
residual volume =
adduction
a completed PDP
informed consent documents (4)

30. Closer to the head
how IDE's can be granted
superior
central nervous system
6 types of synovial joints

31. Lower than for a PMA device

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32. Gene which protects a cell from becoming cancerous; stops cell cycle if need DNA repair
peripheral nervous system
informed consent documents (4)
synovial joints have
tumor suppressor gene

33. Motion where the body part is extended from the medial line (side- to- side)
abduction
stroke volume
6 types of synovial joints
investigator

34. Oxygen moves from alveoli to the blood - and carbon dioxide moves from the blood to the air within alveoli
g1 - cell cycle
proximal
age - informed consent
during external respiration -

35. G1 - s - g2 - m
therapeutic experiment example 2
sacromere
cell cycle (4)
PMA

36. Protein called tubulin
what microtubules contain
ceramics are (5)
inferior
informed consent

37. As a osmotic barrier; phospholipid bilayer
plasma membrane acts
stress - s
transverse plane
6 types of synovial joints

38. Investigational device exemption - allows companies and researches to use their new devices/technology for investigational use only - used to Generate data before PMA's
IDE
abduction
informed consent
how IDE's can be granted

39. Consists of the nervous tissue that is not enclosed by bone
supination
anterior view
peripheral nervous system
sacromere

40. Nearer to the trunk of the body
proximal
classes of biomaterials (4)
cell cycle (4)
sacromere

41. Metals - ceramics - polymers - biologics
classes of biomaterials (4)
therapeutic experiment
ceramics are (5)
coronary arteries

42. Revisions returned to investigator
flexion
human subject research procedure 3
central nervous system
the protocol for human subject research

43. Water adsorption - reduction of length - reduction of strength - weight loss
g2 - cell cycle
degradation steps
stroke volume
pulse pressure

44. Further from the midline of the body
ER - golgi apparatus
supination
lateral
posterior view

45. Translations - appropriate language - obtained in writing - and informed that they may abstain or withdraw from the study at any time
proximal
rough ER
informed consent documents (4)
human subject research procedure 2

46. ATP production - Kreb's cycle - contains two membranes
PDP
distal
mitochondria
proximal

47. Divides the body into superior and inferior halves
small molecules
class I examples
transverse plane
IRB

48. Protein channels to pass through cell membrane
residual volume =
larger molecules require
cell cycle (4)
transverse plane

49. Moderate risk to the user; most require 510(k)
class II
metals are (6)
IRB review areas (4)
frontal plane

50. Safely and reliably - 'relatively' quickly - into raw materials of nature

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