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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 055 Date of Entry 12/21/2020 
FR Recognition Number 8-548
Standard
ISO ASTM  52915 Third edition 2020-03
Specification for additive manufacturing file format (AMF) Version 1.2
Scope/Abstract
1.1 This document provides the specification for the Additive Manufacturing File Format (AMF), an interchange format to address the current and future needs of additive manufacturing technology.

1.2 This document specifies the requirements for the preparation, display and transmission for the AMF. When prepared in a structured electronic format, strict adherence to an extensible markup language (XML)(1)2 schema supports standards-compliant interoperability.

Note 1: A W3C XML schema definition (XSD) for the AMF is available from ISO from http://standards.iso.org/iso/52915 and from ASTM from www.astm.org/MEETINGS/images/amf.xsd. An implementation guide for such an XML schema is provided in Annex A1.


1.3 It is recognized that there is additional information relevant to the final part that is not covered by the current version of this document. Suggested future features are listed in Annex A2.


1.4 This document does not specify any explicit mechanisms for ensuring data integrity, electronic signatures and encryptions.
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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