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FDA Recognized Consensus Standard ASTM2338-09

Recognition List Number: 023 Publication Date: 05/05/2010


Recognition Number 14-282: ASTM F2338-09, Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method. (Sterility)

Date of Standard: 2009.

Address of Standards Organization:

ASTM International (ASTM)
100 Barr Harbor Drive
West Conshohocken, PA 19428-2959

CDRH Office and Division Associated with Recognized Standards:

Devices Affected:
Any devices that are sterilized and packaged. Packages that can be nondestructively evaluated by this test method include: Rigid and semi-rigid non-lidded trays; trays or cups sealed with porous barrier lidding materials; rigid, nonporous packages; flexible, nonporous packages. This test method is capable of detecting package leaks using an absolute or differential pressure transducer leak detector.

Processes Affected:
510(k), IDE, PMA, PDP, HDE, Design Control Input, Quality System Regulation

Type of Standard:
Horizontal, National

Extent of Recognition:
Complete standard and any annexes

Related CFR Citations and Product Codes:

Relevant Guidance:
To be used in conjunction with ANSI/AAMI/ISO 11607-1 and 11607-2:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, and Part 2: Validation requirements for forming, sealing and assembly processes, and AAMI TIR22:2007, Guidance for ANSI/ AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006.

FDA Technical Contact:
Patrick Weixel
10903 New Jampshire Avenue Building 66, Room3528
Siler Spring MD 20993
Email: patrick.weixel@fda.hhs.gov