Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

058

Date of Entry 05/30/2022

FR Recognition Number

8-584

Standard

ASTM F2146-22
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

Scope/Abstract

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. See Section 4 for limitations.

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.

Public Law, CFR Citation(s) and Procode(s)*

Implantable Medical Devices

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

David M. Saylor

FDA/OC/CDRH/OSEL/DBCMS/

301-796-2626

david.saylor@fda.hhs.gov

Matthew Di Prima

FDA/OC/CDRH/OSEL/DAM/

301-796-2507

matthew.diprima@fda.hhs.gov

Standards Development Organization

ASTM

ASTM International