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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 049 Date of Entry 06/07/2018 
FR Recognition Number 8-463
Standard
ASTM ISO 52901 First edition 2017-08
Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts
Scope/Abstract
This document defines and specifies requirements for purchased parts made by additive manufacturing. It gives guidelines for the elements to be exchanged between the customer and the part provider at the time of the order, including the customer order information, part definition data, feedstock requirements, final part characteristics and properties, inspection requirements and part acceptance methods. It is applicable for use as a basis to obtain parts made by additive manufacturing that meet minimum acceptance requirements. More stringent part requirements can be specified through the addition of one or more supplementary requirements at the time of the order.
Extent of Recognition
Complete standard
Rationale for Recognition
Standard is recognized on a scientific basis: Material characterization.
Public Law, CFR Citation(s) and Procode(s)*
All additively manufactured medical devices
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
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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