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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 061 Date of Entry 12/18/2023 
FR Recognition Number 8-607
Standard
ASTM  F2082/F2082M-23
Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
Scope/Abstract
1.1 This test method describes a procedure for quantitatively determining the martensite-to-austenite or the martensite to R-phase transformation temperature of annealed, aged, shape-set, or tempered nickel-titanium alloy specimens by deforming the specimen in bending and measuring the deformation recovered during heating through the thermal transformation (BFR method).
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FDA recognition of ASTM F2082/F2082M-16 [Rec# 8-437] will be superseded by recognition of ASTM F2082/F2082M-23 [Rec# 8-607]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-437] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-437] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Implantable Medical Devices Containing Nitinol
Relevant FDA Guidance and/or Supportive Publications*
1. Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff, issued July 2021.

2. Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Devices - Guidance for Industry and Food and Drug Administration Staff, issued April 2010.

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 Contacts
 Jason Weaver
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2504
  Jason.Weaver@fda.hhs.gov
 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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