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    Recognized Consensus Standards - Medical Devices

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    Nagaraj Sankar

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    Recognized Consensus Standards - Medical Devices

    Uploaded by

    Nagaraj Sankar
    4 views4 pages

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    Recognized Consensus Standards_ Medical Devices

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    4 views4 pages

    Recognized Consensus Standards - Medical Devices

    Uploaded by

    Nagaraj Sankar

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 4

    FDA Home3 Medical Devices4 Databases5

    Recognized Consensus Standards: Medical Devices


    510(k)7|DeNovo8|Registration|Adverse |Recalls11|PMA12|HDE13|Classification14|Standards15
    & Listing9 Events10
    CFR Title |Radiation-Emitting |X-Ray |Medsun |CLIA20|TPLC21
    6 2116 Products17 Assembler18 Reports19

    New Search Back To Search Results


    Part B: Supplementary Information Sheet (SIS)
    FR Recognition List Number062 Date of Entry 05/29/2024
    FR Recognition Number 14-600
    Standard
    ASTM F1929-23
    Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    Scope/Abstract
    1.1 This test method defines materials and procedures that will detect and locate a leak equal to or greater than
    a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material
    and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.
    After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.

    1.2 Three dye application methods are covered in this test method: injection, edge dip, and eyedropper.

    1.3 These test methods are intended for use on packages with edge seals formed between a transparent
    material and a porous sheet material. The test methods are limited to porous materials which can retain the dye
    penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers
    are especially susceptible to leakage and must be evaluated carefully for use with each test method.

    1.4 These test methods require that the dye penetrant solution have good contrast to the opaque packaging
    material.
    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.
    Transition Period
    FDA recognition of ASTM F1929-15 [Rec# 14-484] will be superseded by recognition of ASTM F1929-23 [Rec#
    14-600]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-484] until
    July 04, 2027. After this transition period, declarations of conformity to [Rec# 14-484] will not be accepted.
    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
    Matthew Beckwith
    CDRH/OPEQ/OHTII/DHTIIC/
    240-402-3393
    [email protected]
    Standards Development Organization
    ASTM ASTM International http://www.astm.org/22
    FDA Specialty Task Group (STG)
    Sterility
    *These are provided as examples and others may be applicable.

    Links on this page:


    1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
    2. http://www.addthis.com/bookmark.php
    3. https://www.fda.gov/
    4. https://www.fda.gov/Medical-Devices
    5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-
    device-databases
    6. /scripts/cdrh/devicesatfda/index.cfm
    7. /scripts/cdrh/cfdocs/cfPMN/pmn.cfm
    8. /scripts/cdrh/cfdocs/cfpmn/denovo.cfm
    9. /scripts/cdrh/cfdocs/cfRL/rl.cfm
    10. /scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
    11. /scripts/cdrh/cfdocs/cfRES/res.cfm
    12. /scripts/cdrh/cfdocs/cfPMA/pma.cfm
    13. /scripts/cdrh/cfdocs/cfHDE/hde.cfm
    14. /scripts/cdrh/cfdocs/cfPCD/classification.cfm
    15. /scripts/cdrh/cfdocs/cfStandards/search.cfm
    16. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
    17. /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
    18. /scripts/cdrh/cfdocs/cfAssem/assembler.cfm
    19. /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm
    20. /scripts/cdrh/cfdocs/cfClia/Search.cfm
    21. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
    22. http://www.astm.org/

    Page Last Updated: 09/09/2024


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    Links on this page:


    1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
    2. http://www.addthis.com/bookmark.php
    3. https://www.fda.gov/
    4. https://www.fda.gov/Medical-Devices
    5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-
    device-databases
    6. /scripts/cdrh/devicesatfda/index.cfm
    7. /scripts/cdrh/cfdocs/cfPMN/pmn.cfm
    8. /scripts/cdrh/cfdocs/cfpmn/denovo.cfm
    9. /scripts/cdrh/cfdocs/cfRL/rl.cfm
    10. /scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
    11. /scripts/cdrh/cfdocs/cfRES/res.cfm
    12. /scripts/cdrh/cfdocs/cfPMA/pma.cfm
    13. /scripts/cdrh/cfdocs/cfHDE/hde.cfm
    14. /scripts/cdrh/cfdocs/cfPCD/classification.cfm
    15. /scripts/cdrh/cfdocs/cfStandards/search.cfm
    16. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
    17. /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
    18. /scripts/cdrh/cfdocs/cfAssem/assembler.cfm
    19. /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm
    20. /scripts/cdrh/cfdocs/cfClia/Search.cfm
    21. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
    22. http://www.astm.org/

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