The ASTM F2338-05, Standard Test Method for Non-destructive Detection of Leaks in Packages by Vacuum Decay Method, was developed using VeriPac PTI-225 and PTI-325 leak test instruments. This test method is a Recognized Consensus Standard by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), effective March 31, 2006 (Reference: Federal Register Notice FR Notice (list #014) [Docket No. 2004N-0226].
The FDA recognizes the entire standard and any annexes, for use in conjunction with AAMI/ANSI/ISO 11607:2000, Packaging for terminally sterilized medical devices, 2nd edition, and AAMI TIR 22: 1998, TIR 22/A1:2001. Processes affected include 510(K), IDE, PMA, PDP, HDE, Design Control Input, Quality System Regulation.
According to the FDA Consensus Standard Recognition Notice of March 31, 2006, devices that are affected include any devices that are sterilized and packaged. Packages that can be non-destructively evaluated by this method include: Rigid and semi-rigid non-lidded trays; trays or cups sealed with porous barrier lidding materials; rigid, nonporous packages; flexible, nonporous packages.