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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 054 Date of Entry 07/06/2020 
FR Recognition Number 8-536
Standard
ISO ASTM  52902:First Edition 2019-07
Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
Scope/Abstract
This document covers the general description of benchmarking test piece geometries along with quantitative and qualitative measurements to be taken on the benchmarking test piece(s) to assess the performance of additive manufacturing (AM) systems.
This performance assessment can serve the following two purposes:
- AM system capability evaluation;
- AM system calibration.
The benchmarking test piece(s) is (are) primarily used to quantitatively assess the geometric performance of an AM system. This document describes a suite of test geometries, each designed to investigate one or more specific performance metrics and several example configurations of these geometries into test piece(s). It prescribes quantities and qualities of the test geometries to be measured but does not dictate specific measurement methods. Various user applications can require various grades of performance. This document discusses examples of feature configurations, as well as measurement uncertainty requirements, to demonstrate low and high grade examination and performance. This document does not discuss a specific procedure or machine settings for manufacturing a test piece, which are covered by ASTM F 2971 and other relevant process specific specifications.
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
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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