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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 056 Date of Entry 06/07/2021 
FR Recognition Number 8-561
Standard
ASTM ISO  52950 First edition 2021-01
Additive manufacturing - General principles - Overview of data processing
Scope/Abstract
This document covers the principal considerations which apply to data exchange for additive manufacturing. It specifies terms and definitions which enable information to be exchanged describing geometries or parts such that they can be additively manufactured. The data exchange method outlines file type, data enclosed formatting of such data and what this can be used for.

This document
- enables a suitable format for data exchange to be specified,
- describes the existing developments for additive manufacturing of 3D geometries,
- outlines existing file formats used as part of the existing developments, and
- enables understanding of necessary features for data exchange, for adopters of this document.

This document is aimed at users and producers of additive manufacturing processes and associated software systems. It applies wherever additive processes are used, and to the following fields in particular:
- producers of additive manufacturing systems and equipment including software;
- software engineers involved in CAD/CAE systems;
- reverse engineering systems developers;
- test bodies wishing to compare requested and actual geometries.
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 FDA 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 Contact
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@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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