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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.
Don't refresh. All questions and answers are randomly picked and ordered every time you load a test.

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. Requires energy; move from low concentration to high concentration
therapeutic experiment
lower ion concentration of Cl
a 'biodegradable' product has the ability to break down
active transport

2. The most important aspect governing the ethics of human experimentation
informed consent
why 510(k)'s standard for clearance is lower
plasma membrane acts
heart failure

3. Provide additional knowledge without direct benefit to the patient
non - therapeutic experiment
competence - informed consent
class III examples
IRB

4. Revisions returned to investigator
investigator
human subject research procedure 3
conflict of interest - informed consent
pulse pressure

5. Implantable pacemakers - bone implants
class III 510(k) requiring examples
ceramics are (5)
therapeutic experiment example 1
lateral

6. Growth phase 2
healing response
g2 - cell cycle
midsagittal plane
s - cell cycle

7. By an IRB with or without the FDA

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8. Translations - appropriate language - obtained in writing - and informed that they may abstain or withdraw from the study at any time
informed consent documents (4)
class II
medial
oncogene

9. Moderate risk to the user; most require 510(k)
IRB
class II
lower ion concentration of Cl
coronary arteries

10. As a osmotic barrier; phospholipid bilayer
milestones
plasma membrane acts
visceral pleura
non - therapeutic experiment

11. Contains ribosomes - protein synthesis
anterior view
rough ER
what microtubules contain
adduction

12. Elastic bandages - crutches - exam gloves - hand- held surgical instruments
PDP
synovial joints have
class I examples
distal

13. Motion where the body part is extended toward the medial line (side- to- side)
investigator
adduction
why 510(k)'s standard for clearance is lower
small molecules

14. Water adsorption - reduction of length - reduction of strength - weight loss
degradation steps
supination
residual volume =
central nervous system

15. Extracellular
Lower ion concentration of K
ER - golgi apparatus
class II examples
non - therapeutic experiment example 1

16. Mitosis
510(k)'s standard for clearance
ER - golgi apparatus
supination
m - cell cycle

17. V diastole - V systole
class II examples
stroke volume
mean arterial pressure
adduction

18. One which has direct benefit to the patient
therapeutic experiment
peripheral nervous system
strain - e
class II examples

19. Evaluations based on adherence to regulations and assurances of patient safety; may also suggest scientific improvements
the protocol for human subject research
class II
conflict of interest - informed consent
routes for registerting a new medical device in the US (4)

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

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21. F/ A0
therapeutic experiment example 1
rough ER
stress - s
why 510(k)'s standard for clearance is lower

22. Growth phase 1
g1 - cell cycle
lateral
biodegradable materials have
attaining informed consent (3)

23. Product development protocol - alternatives to IDE and PMA processes for new devices
PDP
class I examples
510(k)'s standard for clearance
healing response

24. Protein called tubulin
what microtubules contain
class II examples
two ways larger molecules pass through cell membrane
attaining informed consent (3)

25. Intracellular
sagittal plane
lower ion concentration of Cl
why 510(k)'s standard for clearance is lower
stress - s

26. Blood pressure cuffs - venipuncture materials (IVs - drawing blood - infusion pumps) - powered wheelchairs - surgical drapes
transverse plane
class II examples
flexion
sacromere

27. 'substantial equivalence' to another approved and safe device to technology currently on the market
FDA
class II
lateral
510(k) must prove this

28. Trial of artificial kidneys
parietal pleura
functional residual capacity =
therapeutic experiment example 2
pulse pressure

29. Injury with tissue - bleeding and clotting (coagulation cascade) - acute inflammation - pink granulation tissues replaces matrix - tissue is remodeled back to original state
g2 - cell cycle
investigator
healing response
IDE

30. 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
PMA
distal
informed consent
parietal pleura

31. Further from the midline of the body
FDA
lateral
investigator
human subject research procedure 4

32. R-R interval
heart rate given by (EKG)
g1 - cell cycle
posterior view
medial

33. Total lung capacity - inspiratory capacity
functional residual capacity =
age - informed consent
human subject research procedure 2
distal

34. Passive and active transport
how IDE's can be granted
two ways larger molecules pass through cell membrane
functional residual capacity =
sagittal plane

35. Ee

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36. ATP production - Kreb's cycle - contains two membranes
medial
attaining informed consent (3)
mitochondria
strain - e

37. Lower than for a PMA device

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38. Genotyping to determine risk factors for disease
during external respiration -
510(k) must prove this
stroke volume
non - therapeutic experiment example 2

39. ?l/l0
Hooke's law - s
mitochondria
human subject research procedure 3
strain - e

40. Institutional review board - consider the ethical aspects - to evaluate - approve - and monitor proposals to perform human research
class I examples
larger molecules require
IRB
Intracellular

41. PMA - 510(k) notification - IDE - PDP
parietal pleura
routes for registerting a new medical device in the US (4)
heart rate given by (EKG)
Hooke's law - s

42. Consists of all nervous tissue that is enclosed by bone (brain and spinal cord)
routes for registerting a new medical device in the US (4)
central nervous system
metals are (6)
plasma membrane acts

43. Involves carries - channels - or direct diffusion from high concentration to low concentration
oncogene
passive transport
abduction
distal

44. Motion where the body part is extended from the medial line (side- to- side)
sacromere
rough ER
active transport
abduction

45. Investigator
non - therapeutic experiment example 1
cell cycle (4)
human subject research procedure 1
informed consent documents (4)

46. Neared to the end of the limbs
mitochondria
non - therapeutic experiment example 1
Hooke's law - s
distal

47. Protein channels to pass through cell membrane
extension
non - therapeutic experiment example 2
ER - golgi apparatus
larger molecules require

48. Rotational movement of forearm such that the palm is facing anterior when standing in anatomic position
Lower ion concentration of K
supination
milestones
ER - golgi apparatus

49. Hollow - cylindrical structures that aid in cell division by transporting chromosomes
microtubules
FDA
non - therapeutic experiment example 2
tumor suppressor gene

50. Temporary functions; do not require second surgery for removal
PMA
degradation steps
ER - golgi apparatus
biodegradable materials have