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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 046 Date of Entry 12/23/2016 
FR Recognition Number 8-444
Standard
ISO  17296-2 First edition 2015-01-15
Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock
Scope/Abstract
This part of ISO 17296 describes the process fundamentals of Additive Manufacturing (AM). It also gives an overview of existing process categories, which are not and cannot be exhaustive due to the development of new technologies. This part of ISO 17296 explains how different process categories make use of different types of materials to shape a product's geometry. It also describes which type of material is used in different process categories. Specification of feedstock material and requirements for the parts produced by combinations of different processes and feedstock material will be given in subsequent separate standards and are therefore not covered by this part of ISO 17296. This part of ISO 17296 describes the overreaching principles of these subsequent standards.
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
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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