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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 051 Date of Entry 01/14/2019 
FR Recognition Number 8-488
Standard
ASTM  F3301-18a
Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion
Scope/Abstract
1.1 This standard specifies the requirements for thermal post-processing of parts produced via metal powder bed fusion to achieve the required material properties and microstructure to meet engineering requirements. This standard is intended to be referenced by Material Part Property specifications for powder bed fusion. Currently, this standard includes thermal post-processing for the materials including titanium alloys, cobalt 28 chromium 6 molybdenum, alloy UNS N07718, alloy UNS N06625, alloy, UNS 31603 and AlSi10Mg. This specification will be updated as new powder bed fusion material heat treatments are developed.
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.
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
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
 James Coburn
  FDA/OC/OCS/OCET/
  301-796-0286
  james.coburn@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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