ASTM F2384-24 PDF

Full title and description

Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901). Defines chemical, mechanical and metallurgical requirements for wrought Zr-2.5Nb produced for use in surgical implants, supplied as bars or wires and intended for manufacture of orthopaedic and other implantable components.

Abstract

This specification (F2384-24) specifies composition limits, required mechanical properties (tensile strength, yield strength, elongation), microstructure requirements, permitted manufacturing routes (multiple vacuum melting, electron beam melting or equivalent), surface condition and required analyses and tests (heat and product analysis, tensile testing). Values are provided in both SI and inch-pound units (to be used independently). The material is intended for surgical implant applications and is to be supplied in the annealed condition with appropriate surface preparation.

General information

• Status: Active
• Publication date: May 1, 2024 (designation F2384-24; last updated May 2024)
• Publisher: ASTM International
• ICS / categories: 77.120.99 — Other non‑ferrous metals and their alloys (medical/implant materials)
• Edition / version: F2384-24
• Number of pages: 5

Scope

Covers chemical, mechanical and metallurgical requirements for wrought zirconium-2.5niobium alloy (UNS R60901) for manufacture of surgical implants. Applies to material produced as bars or wires by vacuum/controlled melting routes, supplied in the annealed condition with defined surface preparation and requiring specified heat/product analyses and mechanical testing. Does not address finished-device design or all safety/regulatory obligations of the device manufacturer.

Key topics and requirements

• Chemical composition limits for Zr-2.5Nb (UNS R60901) and control of impurities.
• Mechanical requirements: tensile strength, yield strength, and minimum elongation values and corresponding test methods.
• Metallurgical requirements: required microstructure (fine dispersion of alpha and beta phases; avoidance of coarse elongated alpha platelets).
• Permitted manufacturing routes: multiple vacuum melting (arc), electron beam melting or equivalent processes for reactive metals.
• Product forms: bars and wires intended for further fabrication into implant components.
• Heat and product analysis: mandatory chemical analyses and records linked to heat/product traceability.
• Surface condition and finish: requirements for annealed condition and acceptable surface treatments (descaling, pickling, abrasive blasting, chemical milling, grinding, machining, peeling, polishing).
• Unit systems: SI and inch‑pound units provided separately (do not combine values from the two systems).
• Quality and testing: requirements for tensile testing, acceptance criteria and manufacturer documentation.

Typical use and users

Used by implant component manufacturers, biomaterials and metallurgical engineers, raw‑material suppliers, quality and regulatory teams in medical device companies, and testing laboratories. Typical applications include orthopaedic and other surgical implants where zirconium-niobium alloy properties are desired (corrosion resistance, biocompatibility, specific mechanical performance).

Related standards

Commonly referenced companion standards and guides in the field of metallic implant materials include other ASTM F standards (examples: F136 — wrought Ti‑6Al‑4V ELI for surgical implants; F67 — unalloyed titanium for surgical implants; F75/F799 — cobalt‑chromium alloys for implants; F746 — pitting/crevice corrosion test methods; F86 — surface preparation and marking; F748 — selection of biological test methods) and international standards for implant metals (ISO/EN series such as ISO 5832 parts covering metallic implant materials). Device manufacturers typically use F2384-24 alongside these material, corrosion and biological evaluation standards.

Keywords

zirconium-2.5niobium, UNS R60901, surgical implants, implant alloy, wrought alloy, vacuum melting, electron beam melting, mechanical properties, metallurgical requirements, ASTM F2384-24

FAQ

Q: What is this standard?

A: ASTM F2384-24 is the ASTM International standard specification that defines the chemical, mechanical and metallurgical requirements for wrought zirconium-2.5niobium alloy (UNS R60901) intended for surgical implant applications.

Q: What does it cover?

A: It covers permitted manufacturing routes (bars and wires produced by vacuum or electron beam melting), required composition limits and impurity controls, mechanical property requirements (tensile, yield, elongation), microstructure criteria, surface/finish expectations, and required heat and product analyses and testing. It provides values in SI and inch‑pound units (to be used separately).

Q: Who typically uses it?

A: Implant manufacturers, biomaterials engineers, raw material suppliers, quality/inspection labs, and regulators or notified bodies reviewing implant material compliance.

Q: Is it current or superseded?

A: Current — the active edition is F2384-24 (published May 2024). It supersedes the earlier F2384-10 (and its 2016 reaffirmation/amendment versions).

Q: Is it part of a series?

A: It is part of the ASTM F04 (Medical and Surgical Materials and Devices) portfolio and is used alongside related ASTM F standards and relevant ISO/EN implant material standards covering titanium, stainless steel and cobalt-chromium alloys and tests.

Q: What are the key keywords?

A: Zirconium-2.5Niobium, UNS R60901, surgical implant alloy, wrought alloy, ASTM F2384-24, implant materials, vacuum melting, mechanical properties, biocompatible metal.