Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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8-529
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Standard | |
ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
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Scope/Abstract1.1 This specification covers the requirements for wrought nickel-titanium shape memory alloy tube, nominally 54.5 to 57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F2063.
1.2 This specification applies to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness. |
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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 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. |