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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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:
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, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
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
  10903 New Hampshire Avenue WO66 RM4278
  Silver Spring MD 20993
  email: Patrick.Weixel@fda.hhs.gov