| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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14-584
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| Standard | |
ASTM F2391-22
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
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Scope/Abstract1.1 This test method includes several procedures that can be used for the measurement of overall package and seal barrier performance of a variety of package types and package forms, as well as seal/closure types. The basic elements of this method include:
1.1.1 Helium (employed as tracer gas),
1.1.2 Helium leak detector (mass spectrometer), and
1.1.3 Package/product-specific test fixtures.
1.1.4 Most applications of helium leak detection are destructive, in that helium needs to be injected into the package after the package has been sealed. The injection site then needs to be sealed/patched externally, which often destroys its saleability. Alternatively, if helium can be incorporated into the headspace before sealing, the method can be non-destructive because all that needs to be accomplished is to simply detect for helium escaping the sealed package.
1.2 Two procedures are described; however the supporting data in Section 14 only reflects Procedure B (Vacuum Mode). The alternative, Sniffer Mode, has proven to be a valuable procedure for many applications, but may have more variability due to exactly the manner that the operator conducts the test such as whether the package is squeezed, effect of multiple small leaks compared to fewer large leaks, background helium concentration, package permeability and speed at which the scan is conducted. Further testing to quantify this procedure's variability is anticipated, but not included in this version.
1.2.1 Procedure A: Sniffer Mode-the package is scanned externally for helium escaping into the atmosphere or fixture.
1.2.2 Procedure B: Vacuum Mode-the helium containing package is placed in a closed fixture. After drawing a vacuum, helium escaping into the closed fixture (capture volume) is detected. Typically, the fixtures are custom made for the specific package under test.
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ASTM F2391-05 (Reapproved 2016) [Rec# 14-169] will be superseded by recognition of ASTM F2391-22 [Rec# 14-584]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-169] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 14-169] will not be accepted. |
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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. |
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Relevant FDA Guidance and/or Supportive Publications*
1. ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
2. ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
3. ISO/TS 16775 Second edition 2021-11 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. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
