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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 8-339
Standard
ASTM F1091-12
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
Scope/Abstract
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought cobalt-20chromium-15tungsten-10nickel surgical fixation wire.
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FDA recognition of ASTM F1091-12 [Rec# 8-339] will be superseded by recognition of ASTM F1091-20 [Rec# 8-540]. FDA will accept declarations of conformity, in support of premarket submissions, to [ Rec# 8-339] until December 17, 2023. After this transition period, declarations of conformity to [ Rec# 8-339] 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 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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