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

8-533

Standard

ISO ASTM 52907: First Edition 2019-11
Additive Manufacturing - Feedstock materials - Methods to characterize metal powders

Scope/Abstract

1.1 This document provides technical specifications for metallic powders intended to be used in additive manufacturing and covers the following aspects:

- documentation and traceability;

- sampling;

- particle distribution;

- chemical composition;

- characteristic densities;

- morphology;

- flowability;

- contamination;

- packaging and storage.

This document does not deal with safety aspects.

In addition, this document gives specific requirements for used metallic powders in additive manufacturing.

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