| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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036
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Date of Entry 07/09/2014
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|
FR Recognition Number
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14-433
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| Standard | |
ASTM F2227-13 (Reapproved 2021)
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method |
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Scope/Abstract| 1.1 This non-destructive test method detects pinhole leaks in trays, as small as 50 μm (0.002 in.) in diameter, or equivalently d cracks, subject to trace gas concentration in the tray, tray design and manufacturing tolerances. |
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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. |
|
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*
| 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. |
