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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 057 Date of Entry 12/20/2021 
FR Recognition Number 8-564
Standard
ASTM  F2005-21
Standard Terminology for Nickel-Titanium Shape Memory Alloys
Scope/Abstract
1.1 This terminology is a compilation of definitions of terms used in ASTM documents relating to nickel-titanium shape memory alloys used for medical devices. This terminology includes only those terms for which ASTM either has standards or which are used in ASTM standards for nickel-titanium shape memory alloys. It is not intended to be an all-inclusive list of terms related to shape memory alloys.

1.2 Definitions that are similar to those published by another standards body are identified with abbreviations of the name of that organization; for example, ICTAC is the International Confederation for Thermal Analysis and Calorimetry.
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.
Public Law, CFR Citation(s) and Procode(s)*
All Medical Devices
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
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@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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