| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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8-563
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| Standard | |
ASTM F1801-20
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
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Scope/Abstract| 1.1 This practice covers the procedure for performing corrosion fatigue tests to obtain S-N (3.2.1) fatigue curves or statistically derived fatigue strength values, or both, for metallic implant materials. This practice describes the testing of axially loaded fatigue specimens subjected to a constant amplitude, periodic forcing function in saline solution at 37°C and in air at room temperature. The environmental test method for implant materials may be adapted to other modes of fatigue loading such as bending or torsion. While this practice is not intended to apply to fatigue tests on implantable components or devices, it does provide guidelines for fatigue tests with standard specimens in an environment related to physiological conditions. |
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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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Public Law, CFR Citation(s) and Procode(s)*
| Implantable Medical Devices |
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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 Contacts
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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. |
