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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 053 Date of Entry 12/23/2019 
FR Recognition Number 8-499
Standard
ASTM  F1580-18
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
Scope/Abstract
1.1 This specification covers the requirements for unalloyed titanium and Ti-6Al-4V alloy powders for use in fabricating coatings on titanium alloy implants.

1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.

1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them.

1.4 Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriate guidelines.
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)*
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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