Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

043

Date of Entry 06/27/2016

FR Recognition Number

8-432

Standard

ISO ASTM 52921 First Edition 2013-06-01
Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.

Scope/Abstract

1.1 This terminology includes terms, definitions of terms, descriptions of terms, nomenclature, and acronyms associated with coordinate systems and testing methodologies for additive manufacturing (AM) technologies in an effort to standardize terminology used by AM users, producers, researchers, educators, press/media, and others, particularly when reporting results from testing of parts made on AM systems. Terms included cover definitions for machines/systems and their coordinate systems plus the location and orientation of parts. It is intended, where possible, to be compliant with ISO 841 and to clarify the specific adaptation of those principles to additive manufacturing.
Note 1-The applicability of this standard to cladding has to be evaluated. Discussions are under progress.
Note 2-Non-cartesian systems are not covered by this standard.

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 Organizations