Medical Device Package Testing
Packaged product in the Sterile Barrier System must protect and maintain the sterility of the product from manufacture through the distribution environment to the point of end-use. The Sterile Barrier System will be subjected to a variety of tests which include package performance testing, accelerated aging, material evaluation, and sterile integrity testing.
Environmental Testing:
Accelerated Aging (ASTM F1980)
Environmental Conditioning
Environmental Conditioning
Package Performance Testing:
Shock:
Manual Handling (ASTM D5276)
Concentrated Impact (ASTM D6344)
Concentrated Impact (ASTM D6344)
Compression
Vehicle Stacking (ASTM D642)
Vibration
Loose Load Vibration (ASTM D999)
Vehicle Vibration (ASTM D4728)
Vehicle Vibration (ASTM D4728)
Altitude
Low Pressure (ASTM D6653)
Sterile Package Integrity Testing:
Dye Penetration (ASTM F1929)
Gross Leak "Bubble" Test (ASTM F2096)
Tensile Strength (ASTM F88)
Burst Test (ASTM F1140)
Gross Leak "Bubble" Test (ASTM F2096)
Tensile Strength (ASTM F88)
Burst Test (ASTM F1140)
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