| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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8-413
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| Standard | |
ASTM F2819-10 (Reapproved 2015)
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices |
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Scope/Abstract1.1 This standard covers the various test methods to be used for measurement of straightness of bar, rod, tubing, and wire. These test methods apply primarily to bar, rod, tubing, and wire that are ordered in the straightened and cut-to-length condition. They also apply to small diameter tubing and wire that has been specially processed to roll off a spool in the straightened condition.
1.2 These test methods apply to straightness of round wire that has a diameter between 0.05 and 4.78 mm (0.002 and 0.188 in.). They also apply to flatness (camber) of flat-shaped wire or ribbon with a maximum dimension between 0.05 and 4.78 mm (0.002 and 0.188 in.). For flatness (camber) measurement, refer to Test Method F2754/F2754M.
Note 1: The current version of Test Method F2754/F2754M covers a different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and does not include superelastic NiTi. These exceptions would not affect the camber measurement as conducted by Test Method F2754/F2754M.
1.3 These test methods apply to straightness of round tubing that has an outer diameter between 0.05 and 6.35 mm (0.002 and 0.25 in.).
1.4 These test methods apply to straightness of round rod that has a diameter between 4.78 and 6.35 mm (0.188 and 0.25 in). It also applies to flatness (camber) of flat and shaped rod with a maximum dimension between 4.78 and 6.35 mm (0.188 and 0.25 in). For measurement of flatness (camber), refer to Test Method F2754/F2754M.
Note 2: The current version of Test Method F2754/F2754M covers a different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and does not include superelastic NiTi. These exceptions would not affect the camber measurement as conducted by Test Method F2754/F2754M.
1.5 These test methods apply to straightness of round bar that has a diameter between 6.35 and 101.6 mm (0.25 and 4 in). It also applies to flatness (camber) of flat and shaped bar with a maximum dimension between 6.35 and 101.6 mm (0.25 and 4 in). For measurement of flatness (camber), refer to Test Method F2754/F2754M.
Note 3: The current version of Test Method F2754/F2754M covers a different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and does not include superelastic NiTi. These exceptions would not affect the camber measurement as conducted by Test Method F2754/F2754M.
1.6 These test methods apply to ferrous and non-ferrous alloys including linear-elastic or superelastic nitinol. Refer to Terminology F2005 for more details on NiTi terminology. |
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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. |
