Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

046

Date of Entry 12/23/2016

FR Recognition Number

8-440

Standard

ASTM F3091/F3091M-14
Standard Specification for Powder Bed Fusion of Plastic Materials

Scope/Abstract

1.1 This specification describes a method for defining requirements and ensuring component integrity for plastic parts created using powder bed fusion processes. Materials include unfilled formulations and formulations containing fillers, functional additives (for example, flame retardant), and reinforcements or combinations thereof. Processes include all powder bed fusion processes as defined in Terminology F2792.

1.2 This specification is intended for use by manufacturers of plastic parts using powder bed fusion and for customers procuring such parts.

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*

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

James Coburn

FDA/OC/OCS/OCET/

301-796-0286

james.coburn@fda.hhs.gov

Standards Development Organization

ASTM

ASTM International