Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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8-534
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Standard | |
ASTM ISO 52911-1: First Edition 2019-07 Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals |
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Scope/AbstractThis document specifies the features of laser-based powder bed fusion of metals (PBF-LB/M) and provides detailed design recommendations. Some of the fundamental principles are also applicable to other additive manufacturing (AM) processes, provided that due consideration is given to process-specific features. This document also provides a state of the art review of design guidelines associated with the use of powder bed fusion (PBF) by bringing together relevant knowledge about this process and by extending the scope of ISO/ASTM 52910. |
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Extent of Recognition
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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. |
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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. |
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FDA Technical Contacts
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |