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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 12/23/2024 
FR Recognition Number 8-622
Standard
ASTM  F2004-24
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
Scope/Abstract
1.1 This test method defines procedures for quantitatively determining the transformation temperatures and enthalpies of nickel-titanium shape memory alloys, produced in accordance with Specification F2063, by differential scanning calorimetry.
1.2 This test method may be used for heat-treated samples in the aged, annealed shape-set, or tempered condition. See Terminology F2005 for definitions of these heat treat conditions.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of ASTM F2004-17 [Rec# 8-476] will be superseded by recognition of ASTM F2004-24 [Rec# 8-622]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-476] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-476] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
All Medical Devices
Relevant FDA Guidance and/or Supportive Publications*
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol-Guidance for Industry and Food and Drug Administration Staff, issued
July 2021.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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