|Recognition List Number: 036 FR Publication Date: 07/09/2014
Part B: Supplementary Information
Recognition Number 14-282: ASTM F2338-09 (Reapproved 2013), standard test method for nondestructive detection of leaks in packages by vacuum decay method. (Sterility)
Date of Standard: 2009.
|Address of Standards Development Organization:|
| ASTM International (ASTM)|
| 100 Barr Harbor Drive|
| West Conshohocken, PA 19428-2959 |
|CDRH Office and Division associated with recognized standards:|
|ALL OFFICES AND DIVISIONS IN CDRH |
|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, International|
|Extent of Recognition:|
|Related CFR Citations and Product Codes:|
|This standard is relevant for all medical devices where sterilization and packaging are components of the development and manufacture of the product.|
|Relevant Guidance: |
|ANSI/AAMI/ISO 11607-1:2006(R2010) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)].
ANSI/AAMI/ISO 11607-2:2006(R2010) Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly process [Including: Amendment 1 (2014)].
ANSI/AAMI/ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.
|FDA Technical Contact:|
| Patrick Weixel |
| FDA/CDRH/OIR |
| 10903 New Hampshire Avenue WO66 RM4278 |
| Silver Spring MD 20993 |
| 301/796-5537 |
| email: Patrick.Weixel@fda.hhs.gov|