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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. lower ion concentration of Na
IRB
sacromere
Intracellular
midsagittal plane

2. PMA - 510(k) notification - IDE - PDP
frontal plane
milestones
class I
routes for registerting a new medical device in the US (4)

3. Protein channels to pass through cell membrane
larger molecules require
the protocol for human subject research
oncogene
ER - golgi apparatus

4. What specific steps are required before market approval
510(k)'s standard for clearance
What a PDP - sponsor and FDA agree on
biodegradable materials have
two ways larger molecules pass through cell membrane

5. Investigational device exemption - allows companies and researches to use their new devices/technology for investigational use only - used to Generate data before PMA's
parietal pleura
non - therapeutic experiment
Lower ion concentration of K
IDE

6. G1 - s - g2 - m
proximal
510(k) must prove this
cell cycle (4)
sacromere

7. One which has direct benefit to the patient
therapeutic experiment
posterior view
visceral pleura
Hooke's law - s

8. As the lung grows into the pleural cavity - it picks of a layer of this
active transport
stress - s
visceral pleura
informed consent documents (4)

9. Injury with tissue - bleeding and clotting (coagulation cascade) - acute inflammation - pink granulation tissues replaces matrix - tissue is remodeled back to original state
healing response
functional residual capacity =
human subject research procedure 4
rough ER

10. Divides the body in left and right halves; aka median plane
proximal
two ways larger molecules pass through cell membrane
midsagittal plane
rough ER

11. <25% results in heart failure
informed consent documents (4)
FDA
coronary arteries
if the stroke volume is less than this

12. Three classes
device classification has
mitochondria
healing response
distal

13. Passive and active transport
peripheral nervous system
lateral
two ways larger molecules pass through cell membrane
cardiac output

14. Toward the midline of the body
medial
sacromere
stress - s
510(k)'s standard for clearance

15. Cardiac output < demand
degradation steps
heart failure
attaining informed consent (3)
larger molecules require

16. Gene which protects a cell from becoming cancerous; stops cell cycle if need DNA repair
Intracellular
class I
tumor suppressor gene
510(k) must prove this

17. Total lung capacity - inspiratory capacity
what microtubules contain
functional residual capacity =
g2 - cell cycle
heart rate given by (EKG)

18. Product development protocol - alternatives to IDE and PMA processes for new devices
stress - s
two ways larger molecules pass through cell membrane
PDP
frontal plane

19. Initiates human research study protocol - It's a document that outlines in detail scientific purpose of study - methods used - possible risks to patient - etc
investigator
ceramics are (5)
ER - golgi apparatus
IRB

20. Further from the midline of the body
medial
lateral
extension
larger molecules require

21. Intracellular
lower ion concentration of Cl
What a PDP - sponsor and FDA agree on
degradation steps
attaining informed consent (3)

22. Vertical planes passing through the body parallel to the midsagittal plane
FDA
sagittal plane
cardiac output
6 types of synovial joints

23. 2/3 diastolic pressure + 1/3 systolic pressure
heart rate given by (EKG)
mean arterial pressure
central nervous system
6 types of synovial joints

24. Translations - appropriate language - obtained in writing - and informed that they may abstain or withdraw from the study at any time
pulse pressure
anterior view
supination
informed consent documents (4)

25. Programmed cell death
a 'biodegradable' product has the ability to break down
synovial joints have
apoptosis
class I examples

26. Total lung capacity - vital capacity
510(k) must prove this
larger molecules require
residual volume =
ER - golgi apparatus

27. Study of the impact of hepatitis infection
class III
Hooke's law - s
m - cell cycle
non - therapeutic experiment example 1

28. Replacement heart valves - stents - breast implants
non - therapeutic experiment
superior
class III examples
IDE

29. Consists of all nervous tissue that is enclosed by bone (brain and spinal cord)
lower ion concentration of Cl
peripheral nervous system
central nervous system
synovial joints have

30. Revisions returned to investigator
passive transport
frontal plane
human subject research procedure 3
cardiac output

31. Gliding - pivot - saddle - ball- and- socket - condyloid - hinge
if the stroke volume is less than this
transverse plane
ER - golgi apparatus
6 types of synovial joints

32. 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
oncogene
pronation
central nervous system
PMA

33. Hollow - cylindrical structures that aid in cell division by transporting chromosomes
microtubules
ER - golgi apparatus
heart failure
anterior view

34. Front view (palms up)
ceramics are (5)
posterior view
anterior view
frontal plane

35. 'substantial equivalence' to another approved and safe device to technology currently on the market
therapeutic experiment
510(k) must prove this
human subject research procedure 1
human subject research procedure 2

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

37. Involves carries - channels - or direct diffusion from high concentration to low concentration
degradation steps
passive transport
510(k) must prove this
abduction

38. Number of subjects - safety assurances - privacy protection - informed consent documents
residual volume =
posterior view
Intracellular
IRB review areas (4)

39. Neared to the end of the limbs
510(k) must prove this
human subject research procedure 3
functional residual capacity =
distal

40. Contains ribosomes - protein synthesis
competence - informed consent
attaining informed consent (3)
rough ER
IDE

41. Protein called tubulin
a completed PDP
Hooke's law - s
human subject research procedure 3
what microtubules contain

42. Delivers and stores proteins and lipids
degradation steps
active transport
ER - golgi apparatus
stress - s

43. Requires energy; move from low concentration to high concentration
active transport
ceramics are (5)
degradation steps
a 'biodegradable' product has the ability to break down

44. Divides the body into superior and inferior halves
510(k)'s standard for clearance
transverse plane
Lower ion concentration of K
small molecules

45. Provide additional knowledge without direct benefit to the patient
s - cell cycle
sacromere
lower ion concentration of Cl
non - therapeutic experiment

46. Water adsorption - reduction of length - reduction of strength - weight loss
pronation
class I
degradation steps
lateral

47. Metals - ceramics - polymers - biologics
oncogene
IDE
human subject research procedure 4
classes of biomaterials (4)

48. Revised version resubmitted to IRB for approval
posterior view
human subject research procedure 4
class III 510(k) requiring examples
Hooke's law - s

49. Strong and ductile - good conductor of heat and electricity - high melting point - high density - shiny and reflective - numerous
parietal pleura
cell cycle (4)
metals are (6)
abduction

50. Considered a successful PMA
a completed PDP
residual volume =
IRB
anterior view