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Test your basic knowledge |
Introduction To Biomedical Engineering
Start Test
Study First
Subject
:
engineering
Instructions:
Answer 50 questions in 15 minutes.
If you are not ready to take this test, you can
study here
.
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. Serious level of risk; implants or necessary to sustain life; require PMA
functional residual capacity =
larger molecules require
lateral
class III
2. Moderate risk to the user; most require 510(k)
class II
s - cell cycle
class II examples
why 510(k)'s standard for clearance is lower
3. Nearer to the trunk of the body
proximal
class III examples
ER - golgi apparatus
What a PDP - sponsor and FDA agree on
4. ATP production - Kreb's cycle - contains two membranes
transverse plane
competence - informed consent
mitochondria
microtubules
5. Contains ribosomes - protein synthesis
flexion
rough ER
parietal pleura
class II examples
6. Because the devices may not state that they FDA- approved
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7. Hollow - cylindrical structures that aid in cell division by transporting chromosomes
heart failure
IRB
microtubules
peripheral nervous system
8. Revisions returned to investigator
therapeutic experiment example 1
human subject research procedure 3
510(k) must prove this
inferior
9. Motion where angle of joint is decreased in the sagittal plane
flexion
510(k)'s standard for clearance
IRB review areas (4)
parietal pleura
10. Front view (palms up)
investigator
non - therapeutic experiment example 1
IRB
anterior view
11. Motion where the body part is extended from the medial line (side- to- side)
abduction
class II examples
stroke volume
human subject research procedure 2
12. Initiates human research study protocol - It's a document that outlines in detail scientific purpose of study - methods used - possible risks to patient - etc
class II
classes of biomaterials (4)
why IDE's are common
investigator
13. ?l/l0
6 types of synovial joints
human subject research procedure 4
transverse plane
strain - e
14. Considered a successful PMA
extension
heart rate given by (EKG)
competence - informed consent
a completed PDP
15. Divides the body in posterior and anterior halves
routes for registerting a new medical device in the US (4)
central nervous system
frontal plane
ER - golgi apparatus
16. Neared to the end of the limbs
class III
rough ER
distal
microtubules
17. Protein called tubulin
what microtubules contain
PMA
microtubules
heart rate given by (EKG)
18. <25% results in heart failure
PDP
posterior view
class II
if the stroke volume is less than this
19. Genotyping to determine risk factors for disease
extension
degradation steps
class III 510(k) requiring examples
non - therapeutic experiment example 2
20. Lower than for a PMA device
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21. Requires energy; move from low concentration to high concentration
class III
informed consent documents (4)
proximal
active transport
22. Product development protocol - alternatives to IDE and PMA processes for new devices
pronation
Lower ion concentration of K
PDP
synovial joints have
23. Temporary functions; do not require second surgery for removal
proximal
biodegradable materials have
heart rate given by (EKG)
rough ER
24. When physical or mental incapacity makes it impossible to acquire informed consent - permission from the legal guardian must be granted
visceral pleura
s - cell cycle
competence - informed consent
human subject research procedure 3
25. __________ of PDP are reported to the FDA
milestones
degradation steps
informed consent documents (4)
Lower ion concentration of K
26. Replacement heart valves - stents - breast implants
class III examples
non - therapeutic experiment example 1
FDA
stroke volume
27. The most important aspect governing the ethics of human experimentation
apoptosis
informed consent
PMA
synovial joints have
28. Heart rate x stroke volume
small molecules
cardiac output
m - cell cycle
class I
29. Institutional review board - consider the ethical aspects - to evaluate - approve - and monitor proposals to perform human research
class I examples
sagittal plane
how IDE's can be granted
IRB
30. Number of subjects - safety assurances - privacy protection - informed consent documents
microtubules
class I examples
IRB review areas (4)
FDA
31. PMA - 510(k) notification - IDE - PDP
a 'biodegradable' product has the ability to break down
microtubules
routes for registerting a new medical device in the US (4)
a completed PDP
32. Growth phase 1
sagittal plane
g1 - cell cycle
how IDE's can be granted
therapeutic experiment example 2
33. Cardiac output < demand
synovial joints have
heart failure
human subject research procedure 2
larger molecules require
34. Food and drug administration - in charge of Regulating medical devices for their safety and effectiveness
polymers (5)
FDA
s - cell cycle
milestones
35. Trial of artificial kidneys
therapeutic experiment
class I examples
the protocol for human subject research
therapeutic experiment example 2
36. Consists of all nervous tissue that is enclosed by bone (brain and spinal cord)
residual volume =
during external respiration -
mitochondria
central nervous system
37. 'substantial equivalence' to another approved and safe device to technology currently on the market
class III examples
510(k) must prove this
g1 - cell cycle
Intracellular
38. Consists of the nervous tissue that is not enclosed by bone
informed consent
competence - informed consent
peripheral nervous system
biodegradable materials have
39. Revised version resubmitted to IRB for approval
g1 - cell cycle
human subject research procedure 4
non - therapeutic experiment example 1
510(k) must prove this
40. Extracellular
microtubules
Lower ion concentration of K
apoptosis
competence - informed consent
41. Gene which protects a cell from becoming cancerous; stops cell cycle if need DNA repair
tumor suppressor gene
class III examples
pulse pressure
parietal pleura
42. Involves carries - channels - or direct diffusion from high concentration to low concentration
PMA
proximal
passive transport
non - therapeutic experiment example 1
43. Further from the midline of the body
mitochondria
therapeutic experiment
device classification has
lateral
44. Clinical evaluation of new devices are critical to prove safety
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45. V diastole - V systole
age - informed consent
stroke volume
proximal
human subject research procedure 4
46. Vertical planes passing through the body parallel to the midsagittal plane
sagittal plane
class III examples
g2 - cell cycle
therapeutic experiment
47. Translations - appropriate language - obtained in writing - and informed that they may abstain or withdraw from the study at any time
informed consent documents (4)
PDP
therapeutic experiment example 2
tumor suppressor gene
48. 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
attaining informed consent (3)
healing response
non - therapeutic experiment
PMA
49. Water adsorption - reduction of length - reduction of strength - weight loss
midsagittal plane
degradation steps
PDP
why IDE's are common
50. Flexible - light - can be translucent or not transparent - can be degradable or stable - easy to work with - inexpensive
microtubules
polymers (5)
PDP
a completed PDP