| 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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8-565
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| Standard | |
ASTM F2754/F2754M-21
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire |
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Scope/Abstract1.1 This test method covers the various standard methods that are used for measuring camber, cast, helix, and helix direction. The wire may be coiled with or without a spool.
1.2 This test method applies to round wire that has a diameter between 0.0127 to 4.78 mm [0.0005 to 0.188 in.]. It also applies to flat or shaped wire.
1.3 This test method does not apply to superelastic nitinol wire. It does apply to the as-drawn condition of nitinol wire.
1.4 This test method does not apply to the measurement of the straightness of straightened to length wire and tubing.
1.3 This test method does not apply to superelastic nitinol wire. It does apply to the as-drawn condition of nitinol wire.
1.4 This test method does not apply to the measurement of the straightness of straightened to length wire and tubing. |
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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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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. |
