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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 054 Date of Entry 07/06/2020 
FR Recognition Number 8-535
Standard
ASTM ISO 52911-2: First Edition 2019-09
Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers
Scope/Abstract
This document specifies the features of laser-based powder bed fusion of polymers (LB-PBF/P) and provides detailed design recommendations.
Some of the fundamental principles are also applicable to other additive manufacturing (AM) processes, provided that due consideration is given to process-specific features.
This document also provides a state-of-the-art review of design guidelines associated with the use of powder bed fusion (PBF) by bringing together relevant knowledge about this process and by extending the scope of ISO/ASTM 52910.
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*
Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Additive Manufactured Medical Devices, Issued December 2017.

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
 Daniel Porter
  FDA/OC/CDRH/OSEL/DAM/
  240-402-0206
  Daniel.Porter@fda.hhs.gov
Standards Development Organizations
ASTM ASTM International http://www.astm.org/
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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