Ensuring Patient Safety: A Behind-the-Scenes Look at Medical Device Testing
Ensuring Patient Safety: A Behind-the-Scenes Look at Medical Device Testing
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1
Seal Strength Test:
We make sure the packaging keeps the device sterile during transport and storage.
Seal Strength Test:
We make sure the packaging keeps the device sterile during transport and storage.
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2
Sterility Test:
We eliminate any microorganisms on the device using Ethylene Oxide (ETO) gas.
Sterility Test:
We eliminate any microorganisms on the device using Ethylene Oxide (ETO) gas.
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3
ETO Residual Test:
We ensure any remaining ETO gas is within safe limits after sterilization.
ETO Residual Test:
We ensure any remaining ETO gas is within safe limits after sterilization.
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4
Bioburden Test
: We measure the initial level of microorganisms on the device before cleaning.
Bioburden Test
: We measure the initial level of microorganisms on the device before cleaning.
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5
Cleaning Validation:
We verify the cleaning process effectively removes microorganisms.
Cleaning Validation:
We verify the cleaning process effectively removes microorganisms.
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6
Method Validation:
We ensure all our testing methods are accurate and reliable.
Method Validation:
We ensure all our testing methods are accurate and reliable.
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7
Biocompatibility Assessment:
We test if the device interacts safely with human tissue.
Biocompatibility Assessment:
We test if the device interacts safely with human tissue.
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8
Bacterial Endotoxin Test (BET):
We check for the presence of harmful bacterial toxins on the device.
Bacterial Endotoxin Test (BET):
We check for the presence of harmful bacterial toxins on the device.
After passing all these tests, the device is ready to safely improve patient lives!
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