Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
062
|
Date of Entry 05/29/2024
|
FR Recognition Number
|
8-614
|
Standard | |
ASTM F3456-22 Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials |
|
Scope/AbstractThis specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms are addressed. This specification applies to straight length tubing of specified diameters and thickness. Seamless tubing shall be made from bar, hollow bar, rod, or hollow rod raw material forms through a prescribed process. Welded and drawn tubing shall be made from strip or sheet raw material forms that meet the specified chemical requirements. The tubing shall be subject to tensile testing.
1.1 This guide provides a concise approach for users of powder bed fusion (PBF) processes to communicate the method(s) in which feedstock powders are controlled throughout the feedstock lifecycle. 1.1.1 Regulatory bodies may require descriptions of used powder reuse schemes in a submission. This is because a medical device's performance can be affected by the condition of the powder feedstock and current regulations are not prescriptive to powder. 1.1.2 This guide is intended for users of both polymer and metal feedstock powders. 1.2 This guide does not cover powder specifications, recycling strategy, blending processes, lot control, or address contamination prevention.
|
|
Extent of Recognition
|
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. |
|
Public Law, CFR Citation(s) and Procode(s)*
|
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 Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |