Industrial Reports

ISO-11607 "Packaging for terminally sterilized medical devices"
The ISO 11607 Standard, Packaging for Terminally Sterilized Medical Devices, is a guidance document that describes the process for design, development, validation, process control and final qualification of packages used in the protection of sterile medical devices. Even though this document is pointed specifically at the manufacturer of sterile medical devices, it is a well thought out vehicle to guide any package designer through the complexities of specialized package production. Please be aware that the original document must be purchased from this site.
ASTM E2024 "Standard Test Methods for Atmospheric Leaks Using a Thermal Conductivity Leak Detector"
ASTM F2054 "Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressure Within Restraining Plates"
ASTM F1140 "Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications"
FDA Quality Systems Manual for Packaging
Everything the medical packaging professional should know.

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