Recognized standard

F2005-21

FDA recognition 8-564 · ASTM · Materials

Key facts

Recognition number 8-564
Designation F2005-21
Title Standard Terminology for Nickel-Titanium Shape Memory Alloys
Standards developer ASTM International
Specialty area Materials
Date of entry Dec 20, 2021
Scope (excerpt) 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…

At a glance

  • None Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards