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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Entry 01/15/2013 
FR Recognition Number 14-359
Standard
ASTM  F2096-11 (Reapproved 2019)
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
Scope/Abstract
1.1 This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 μm (0.010 in.) with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.
1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging.
1.3 This test method is destructive in that it requires entry into the package to supply an internal air pressure.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where sterilization and packaging are components of the development and manufacture of the product.
Relevant FDA Guidance and/or Supportive Publications*
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.

ISO/TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Patrick Weixel
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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