Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

055

Date of Entry 12/21/2020

FR Recognition Number

8-553

Standard

ISO ASTM 52903-1 First edition 2020-04
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials

Scope/Abstract

1.1 This document describes a method for defining requirements for plastic materials used in extrusion-based additive manufacturing (AM) processes. Materials include unfilled, filled, and reinforced plastic materials suitable for processing into parts. These materials can also contain special additives (e.g., flame retardants, stabilizers, etc.). Processes include all material extrusion-based AM processes.

This document is intended for use by manufacturers of materials, feedstocks, or plastic parts or any combination of the three using material extrusion-based AM.

Note 1: In some cases, material manufacturers can also be feedstock manufacturers. In other cases, a material manufacturer can supply materials (example: pellets) to a feedstock manufacturer (example: convertor of pellets into filaments).

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