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22 Cards in this Set

  • Front
  • Back
What are the classifications of medical device failure?
1. mechanical failure
2. physio-chemical failure
3. chemical failure
4. device design
List the mechanisms of mechanical failure.
creep
abrasion
stress-cracking
fatigue
tensile failure
Define creep.
long term deformation under load
Define abrasion.
surface failure during working
What two issues might perpetuate mechanical failure?
material choice and testing
Define physio-chemical failure.
dissolution of device/component in bio-fluids
List three examples of physio-chemical failure.
fouling
plasticization, crazing
leaching of plasticizer, filler in bioenvironment
Define fouling.
protein/cell absorption
Define plasticization/crazing.
property decay through water/lipid interactions
List four examples of chemical failure.
materials degradation of device
corrosion
calcification
catastrophic fibrous encapsulation
Define corrosion.
oxidation or reduction of basic chemistry
Define calcification.
growing unwanted bone
List 6 examples of failure resulting from device design.
poor fabrication
sterilization
contamination
damage due to handling
poor surgical procedure
unexpected patient reaction to procedure/device
Define contamination.
catastrophic infection through improper packaging
Define poor fabrication.
off-spec operation
List potential cardiovascular effects (3) that could result from device failure that effect the material.
protein absorption
cell adhesion
plasticization/degradation
List potential cardiovascular effects (4) that could result from device failure that effect the patient.
thrombi formation/embolism
cell injury
tissue damage
hyperplasia
What does SIMS stand for?
secondary-ion mass spectroscopy
What does XPS stand for?
x-ray photoelectron spectroscopy
XPS is commonly used to investigate what?
chemical composition for structures
SIMS is commonly used for what?
solid surfaces and thin films
What is one of the main advantages of SIMS?
can detect elements in the parts per billion range