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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 046 Date of Entry 12/23/2016 
FR Recognition Number 8-437
Standard
ASTM  F2082/F2082M-16
Standard Test Method for 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 determining the martensite-to-austenite transformation temperatures of either fully annealed or heat-treated nickel titanium alloys by measuring the deformation recovered during the thermal transformation.
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FDA recognition of ASTM F2082/F2082M-16 [Rec# 8-437] will be superseded by recognition of ASTM F2082/F2082M-23 [Rec# 8-607].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.
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.
FDA Technical Contact
 Terry O. Woods
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2503
  terry.woods@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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