• 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:
 International, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
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
-
-