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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 065 Date of Entry 12/22/2025 
FR Recognition Number 8-629
Standard
ASTM  F67-24
Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
Scope/Abstract
This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium strips, sheets, plates, bars, billets, forgings, and wires used for the manufacture of surgical implants. The four grades identified here are defined as follows: Grade 1-UNS R50250; Grade 2-UNS R50400; Grade 3-UNS R50550; and Grade 4-UNS R50700. Mill products may be supplied with a descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished finish, or as specified by the purchaser. Materials shall be furnished in the hotworked, cold-worked, forged, annealed, or stress-relieved condition. Mechanical properties to which the titanium materials shall conform are ultimate tensile strength, yield strength, elongation, and reduction of area.
Extent of Recognition
Complete standard
Rationale for Recognition
Standard is recognized on a scientific basis: Material characterization.
Transition Period
FDA recognition of ASTM F67-13 (Reapproved 2017) [Rec# 8-356] will be superseded by recognition of ASTM F67-24 [Rec# 8-629]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-356] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-356] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Implantable 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 Contacts
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@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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