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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. Three classes
m - cell cycle
device classification has
g2 - cell cycle
510(k) must prove this

2. Can pass through cell membrane directly
small molecules
non - therapeutic experiment example 1
human subject research procedure 3
class I

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

4. Provide additional knowledge without direct benefit to the patient
human subject research procedure 2
non - therapeutic experiment
visceral pleura
pulse pressure

5. Oxygen moves from alveoli to the blood - and carbon dioxide moves from the blood to the air within alveoli
What a PDP - sponsor and FDA agree on
during external respiration -
metals are (6)
two ways larger molecules pass through cell membrane

6. Growth phase 2
competence - informed consent
conflict of interest - informed consent
g2 - cell cycle
cell cycle (4)

7. Contains ribosomes - protein synthesis
investigator
lateral
rough ER
flexion

8. Back view (palms up)
synovial joints have
adduction
posterior view
proximal

9. G1 - s - g2 - m
PMA
cell cycle (4)
human subject research procedure 2
midsagittal plane

10. Evaluations based on adherence to regulations and assurances of patient safety; may also suggest scientific improvements
cell cycle (4)
510(k)'s standard for clearance
mean arterial pressure
the protocol for human subject research

11. Motion where angle of joint is increased in the sagittal plane
small molecules
Hooke's law - s
extension
healing response

12. Flexible - light - can be translucent or not transparent - can be degradable or stable - easy to work with - inexpensive
510(k) must prove this
polymers (5)
a 'biodegradable' product has the ability to break down
IRB review areas (4)

13. Implantable pacemakers - bone implants
s - cell cycle
midsagittal plane
class III 510(k) requiring examples
milestones

14. Closer to the feet
human subject research procedure 4
therapeutic experiment
pulse pressure
inferior

15. Blood pressure cuffs - venipuncture materials (IVs - drawing blood - infusion pumps) - powered wheelchairs - surgical drapes
informed consent
IDE
informed consent documents (4)
class II examples

16. Consists of all nervous tissue that is enclosed by bone (brain and spinal cord)
two ways larger molecules pass through cell membrane
midsagittal plane
central nervous system
why IDE's are common

17. Hollow - cylindrical structures that aid in cell division by transporting chromosomes
inferior
human subject research procedure 4
microtubules
therapeutic experiment

18. Toward the midline of the body
extension
510(k)'s standard for clearance
abduction
medial

19. lower ion concentration of Na
Intracellular
ER - golgi apparatus
510(k) must prove this
Hooke's law - s

20. Intracellular
midsagittal plane
s - cell cycle
lower ion concentration of Cl
oncogene

21. Mitosis
small molecules
m - cell cycle
informed consent documents (4)
if the stroke volume is less than this

22. Divides the body into superior and inferior halves
Hooke's law - s
competence - informed consent
investigator
transverse plane

23. Serious level of risk; implants or necessary to sustain life; require PMA
microtubules
510(k) must prove this
class III
heart failure

24. Water adsorption - reduction of length - reduction of strength - weight loss
why 510(k)'s standard for clearance is lower
milestones
degradation steps
device classification has

25. Divides the body in posterior and anterior halves
m - cell cycle
a 'biodegradable' product has the ability to break down
frontal plane
abduction

26. What specific steps are required before market approval
milestones
510(k) must prove this
functional residual capacity =
What a PDP - sponsor and FDA agree on

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

28. Front view (palms up)
inferior
lower ion concentration of Cl
anterior view
Hooke's law - s

29. Elastic bandages - crutches - exam gloves - hand- held surgical instruments
class I examples
investigator
g2 - cell cycle
superior

30. PMA - 510(k) notification - IDE - PDP
during external respiration -
non - therapeutic experiment example 1
central nervous system
routes for registerting a new medical device in the US (4)

31. Fluid- filled cavities and are most complex and varied types of joints
two ways larger molecules pass through cell membrane
superior
synovial joints have
why 510(k)'s standard for clearance is lower

32. Vertical planes passing through the body parallel to the midsagittal plane
IDE
sagittal plane
Intracellular
class I

33. Motion where angle of joint is decreased in the sagittal plane
flexion
visceral pleura
larger molecules require
class III

34. Total lung capacity - inspiratory capacity
Intracellular
s - cell cycle
class I
functional residual capacity =

35. Extracellular
pulse pressure
Lower ion concentration of K
why 510(k)'s standard for clearance is lower
IDE

36. Investigator
a completed PDP
human subject research procedure 1
What a PDP - sponsor and FDA agree on
extension

37. Food and drug administration - in charge of Regulating medical devices for their safety and effectiveness
6 types of synovial joints
posterior view
stroke volume
FDA

38. 'substantial equivalence' to another approved and safe device to technology currently on the market
small molecules
510(k) must prove this
two ways larger molecules pass through cell membrane
stroke volume

39. ?l/l0
mitochondria
strain - e
6 types of synovial joints
non - therapeutic experiment example 2

40. Ee

41. Motion where the body part is extended from the medial line (side- to- side)
informed consent
proximal
what microtubules contain
abduction

42. Revisions returned to investigator
residual volume =
small molecules
the protocol for human subject research
human subject research procedure 3

43. Product development protocol - alternatives to IDE and PMA processes for new devices
why IDE's are common
IRB
competence - informed consent
PDP

44. Closer to the head
abduction
two ways larger molecules pass through cell membrane
superior
Lower ion concentration of K

45. 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
mitochondria
plasma membrane acts
passive transport
PMA

46. Heart rate x stroke volume
non - therapeutic experiment
510(k)'s standard for clearance
class III 510(k) requiring examples
cardiac output

47. ATP production - Kreb's cycle - contains two membranes
metals are (6)
informed consent
biodegradable materials have
mitochondria

48. Trial of artificial kidneys
larger molecules require
FDA
therapeutic experiment example 2
IRB

49. Lower than for a PMA device

50. Stiff and brittle - good insulators of heat and electricity - very high melting point - hard - wear resistant
pulse pressure
ceramics are (5)
visceral pleura
extension