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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 043 Date of Entry 06/27/2016 
FR Recognition Number 8-434
Standard
ISO ASTM  52900 First Edition 2015-12-15
Additive manufacturing -- General principles - Terminology
Scope/Abstract
This International Standard establishes and defines terms used in additive manufacturing (AM) technology, which applies the additive shaping principle and thereby builds physical 3D geometries by successive addition of material.
The terms have been classified into specific fields of application.
New terms emerging from the future work within ISO/TC 261 and ASTM F42 will be included in upcoming amendments and overviews of this International Standard.
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 Organizations
ISO International Organization for Standardization https://www.iso.org/
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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