• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
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:
Regulation
Number
Device Name Device
Class
Product
Code
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
-
-