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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 062 Date of Entry 05/29/2024 
FR Recognition Number 8-617
Standard
ISO ASTM  52926-3 First edition 2023-11
Additive manufacturing of metals - Qualification principles - Part 3: Qualification of operators for PBF-EB
Scope/Abstract
1.1 This document identifies the capabilities and responsibilities required for the qualification of the AM operators on the field of the additive manufacturing technologies dealing with metallic parts production, specifically for the employment of powder bed fusion - electron beam for metals (PBF-EB/M).
1.2 This document identifies criteria for the theoretical and practical assessment of personnel operating PBF-EB/M machines. The activities and procedures foreseen to be performed by the PBF-EB operator are also part of this document.
1.3 This document is intended to provide guidance for qualification of machine operators in general industrial applications.
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.
Public Law, CFR Citation(s) and Procode(s)*
Cross Cutting
Relevant FDA Guidance and/or Supportive Publications*
Technical Considerations for Additive Manufactured Medical Devices: Guidance for Industry and Food and Drug Administration Staff, 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 Contact
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@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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