ASTM F562-22 PDF

Full title and description

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) — ASTM F562-22. This specification defines requirements for the wrought Co‑Ni‑Cr‑Mo alloy commonly known as MP35N (UNS R30035) supplied as bar and wire for surgical implant manufacture, including required chemical composition limits and mechanical-property requirements.

Abstract

This specification covers requirements for wrought 35Co‑35Ni‑20Cr‑10Mo alloy (UNS R30035) in the form of bar and wire for surgical-implant applications. It addresses composition limits and tolerances, mechanical properties (tensile strength, yield strength, elongation, reduction of area), and the heat‑treatment / work‑strengthening approaches used to achieve required combinations of strength and ductility.

General information

• Status: Active / Current specification (2022 edition).
• Publication date: 2022 (ASTM designation F562‑22; ASTM listing updated Jan 2022).
• Publisher: ASTM International (Committee F04 on Medical and Surgical Materials and Devices).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: F562‑22 (2022 edition).
• Number of pages: 6 pages (short, specification format).

Scope

Applies to wrought 35Co‑35Ni‑20Cr‑10Mo alloy (UNS R30035) delivered as bar and wire for the manufacture of surgical implants. The standard specifies material‑identification, required chemical composition and tolerances, mechanical‑property requirements, and the test methods used to demonstrate conformance. It recognizes that property combinations are achieved by combinations of cold work (work‑strengthening), and work‑strengthening followed by aging (precipitation hardening). Values are presented in SI and inch‑pound units (each system to be used independently).

Key topics and requirements

• Chemical composition (typical specified limits for UNS R30035 / MP35N): Co balance; Ni ~33.0–37.0%; Cr ~19.0–21.0%; Mo ~9.0–10.5%; C ≤0.025%; Mn ≤0.15%; Si ≤0.15%; P ≤0.015%; S ≤0.010%; Fe ≤1.0% (typical permitted maxima).
• Mechanical properties — minimum tensile and yield strength, elongation and reduction-of-area requirements for specified product forms and heat‑treatment/working conditions (values depend on cold‑work level and aging; specification requires testing to verify conformance).
• Product forms covered — wrought bar and wire intended for implant manufacture; surface finish and processing notes pertinent to fatigue performance for implant uses.
• Processing and condition control — the specification recognizes work‑strengthening and aging heat treatments as means to attain required property combinations and requires verification testing (tensile, hardness, chemical analysis).
• Referenced test methods — the specification refers to established ASTM/industry test methods for chemical analysis, tensile testing, grain size, and other quality checks (these referenced methods are listed in the standard).

Typical use and users

Used by medical device manufacturers and designers producing implantable devices (e.g., pacemaker/lead components, small implant hardware, fixation devices), alloy/bar/wire suppliers, metallurgical and quality engineers, testing laboratories, and regulatory/standards professionals who specify or verify implant‑grade MP35N (UNS R30035) materials. The alloy is selected when a combination of high strength, corrosion resistance and biocompatibility is required.

Related standards

Commonly cross‑referenced or comparable documents include ISO 5832‑6 (Implants for surgery — wrought cobalt‑nickel‑chromium‑molybdenum alloy), AMS/industry specifications for MP35N (several AMS/ASTM source specifications such as AMS 5758 / AMS 5844 appear in supplier literature), and other ASTM/ISO implant metallurgy standards in the ISO 5832 series. Users often compare ASTM F562 requirements with ISO 5832‑6 when aligning international specifications.

Keywords

ASTM F562‑22; MP35N; UNS R30035; cobalt‑nickel‑chromium‑molybdenum; surgical implants; implant bar; implant wire; work‑strengthened; precipitation‑hardening; biocompatible alloy.

FAQ

Q: What is this standard?

A: ASTM F562‑22 is the ASTM International standard specification that defines requirements for wrought 35Co‑35Ni‑20Cr‑10Mo alloy (UNS R30035 / MP35N) supplied as bar and wire for surgical implant applications.

Q: What does it cover?

A: It covers chemical composition limits and tolerances, mechanical‑property requirements (tensile, yield, elongation, reduction of area), acceptable product forms (bar and wire), and the referenced test methods needed to demonstrate conformance. The standard notes that required properties are obtained via combinations of cold working and aging.

Q: Who typically uses it?

A: Medical device manufacturers (implant designers), raw‑material suppliers (bar/wire producers), metallurgists and QA/QC laboratories, and regulatory/standards teams specifying implantable metal components.

Q: Is it current or superseded?

A: The 2022 edition (F562‑22) is the current ASTM edition released in 2022; it replaces earlier editions (e.g., F562‑13). Users should confirm the edition in force at time of procurement.

Q: Is it part of a series?

A: It is part of the ASTM F series of standards for medical and surgical materials and devices and aligns conceptually with the ISO 5832 series for metallic implant materials (ISO 5832‑6 covers a similar wrought Co‑Ni‑Cr‑Mo implant alloy).

Q: What are the key keywords?

A: MP35N; UNS R30035; cobalt‑nickel alloy; surgical implant alloy; bar; wire; high strength; corrosion resistance; ASTM F562.