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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 8-615
Standard
ISO ASTM  52926-1 First edition 2023-11
Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators
Scope/Abstract
1.1 This document specifies the activities and responsibilities of the AM operators in the field of the additive manufacturing (AM) technologies dealing with metallic parts production.
1.2 This document is intended to provide guidance for qualification of AM machine operators in general industrial applications. Where industry-specific requirements exist for the qualification of AM operators, such as ISO/ASTM 52942 for aerospace applications, those industry-specific standards are used instead of this document.
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*
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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