| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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8-506
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| Standard | |
ASTM F2516-18
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
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Scope/Abstract| 1.1 This test method covers the tension testing of superelastic nickel-titanium (nitinol) materials, specifically the methods for determination of upper plateau strength, lower plateau strength, residual elongation, tensile strength, and elongation. |
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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| FDA recognition of ASTM F2516-18 [Rec# 8-506] will be superseded by recognition of ASTM F2516-22 [Rec# 8-601]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-506] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 8-506] will not be accepted. |
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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. |
