Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

054

Date of Entry 07/06/2020

FR Recognition Number

8-535

Standard

ISO ASTM 52911-2: First Edition 2019-09
Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers

Scope/Abstract

This document specifies the features of laser-based powder bed fusion of polymers (LB-PBF/P) 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.

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