ASTM F139-19 PDF

Full title and description

ASTM F139-19 — Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673). This specification defines the chemical, metallurgical, mechanical, surface-finish, and test requirements for sheet and strip of UNS S31673 intended for use in the manufacture of surgical implants and related medical devices.

Abstract

ASTM F139-19 sets requirements for wrought 18Cr–14Ni–2.5Mo stainless steel in sheet and strip form for surgical implant applications. It covers permitted material conditions (annealed or cold-worked), available surface finishes (dull cold-rolled, bright cold-rolled, various polished and satin/mirror finishes), required examinations and tests (chemical analysis, tensile and hardness testing, and intergranular corrosion susceptibility), and delivery requirements referencing general ASTM flat-rolled stainless-steel requirements.

General information

• Status: Active / Current specification (F139-19).
• Publication date: Approved December 1, 2019; published in ASTM releases February 26, 2020 (designation F139-19).
• Publisher: ASTM International.
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: F139-19 (2019 edition).
• Number of pages: 5 pages (official ASTM document length).

Scope

This specification covers wrought 18Cr–14Ni–2.5Mo stainless steel sheet and strip (UNS S31673) intended for the manufacture of surgical implants. It specifies accepted chemical composition and microstructural characteristics, mechanical-property testing and acceptance, intergranular corrosion susceptibility checks, permitted product forms and surface finishes, and requirements for delivery and documentation. The standard applies to raw material (sheet/strip) and is not a device design standard.

Key topics and requirements

• Chemical composition corresponding to UNS S31673 (nominally ≈18% Cr, 14% Ni, 2.5% Mo) with limits and heat-analysis acceptance criteria.
• Microstructure requirements (austenitic structure appropriate for implant use; limits on ferrite/carbides/intermetallics where applicable).
• Mechanical-property requirements and mandatory testing: tensile and hardness testing and acceptance criteria appropriate to sheet/strip condition (annealed or cold-worked).
• Intergranular corrosion susceptibility testing (to verify resistance to sensitization) and referenced corrosion test methods.
• Permitted product conditions and surface finishes: annealed or cold-worked conditions; finishes including dull/bright cold-rolled, intermediate and general-purpose polish, satin, high-luster and mirror finishes.
• Referenced general requirements and test standards (e.g., ASTM flat-rolled general requirements and referenced test methods for hardness, microetching, corrosion evaluation, etc.).
• Marking, certification and delivery requirements (mill certificates, heat analysis, and conformance to specified test results).

Typical use and users

Material specified by ASTM F139-19 is used by medical-device manufacturers and component suppliers to produce implant components and surgical instruments where sheet or strip form of implant-grade austenitic stainless steel is required. Typical users include orthopedic and spinal device manufacturers, dental implant and restorative component producers, surgical instrument makers, raw-material mills and distributors, quality and regulatory personnel at medical device companies, and testing laboratories performing material qualification and acceptance testing.

Related standards

Commonly associated and cross-referenced standards include ASTM F138 (wrought stainless steel bar and wire for surgical implants), ASTM F1350 (surgical fixation wire), ASTM A480/A480M (general requirements for flat-rolled stainless steel), ASTM E18 (hardness test methods), ASTM E407 (microetching practice) and international equivalents such as ISO 5832-1 (wrought stainless steel for surgical implants). Device- and application-level standards and regulatory guidance may also reference F139 for raw-material acceptance.

Keywords

ASTM F139-19; UNS S31673; 18Cr-14Ni-2.5Mo; surgical implants; stainless steel sheet; stainless steel strip; implant-grade; austenitic stainless; corrosion resistance; tensile; hardness; intergranular corrosion.

FAQ

Q: What is this standard?

A: ASTM F139-19 is a material specification that defines chemical, metallurgical, mechanical and surface-finish requirements for wrought 18Cr–14Ni–2.5Mo stainless steel sheet and strip (UNS S31673) intended for surgical implant use.

Q: What does it cover?

A: It covers composition limits, microstructure expectations, required tests (tensile, hardness, intergranular corrosion susceptibility), allowable product conditions (annealed or cold-worked), available surface finishes, and delivery/record requirements for sheet and strip used to make implants and implant components.

Q: Who typically uses it?

A: Medical-device manufacturers, implant-component suppliers, raw-material mills, distributors, quality and regulatory teams in the medical sector, and testing laboratories use this standard to specify and accept implant-grade sheet and strip material.

Q: Is it current or superseded?

A: The designation F139-19 is the 2019 edition of the standard and is listed as the active/current edition (approved December 1, 2019 and published in ASTM releases February 26, 2020). Users should check with ASTM or their standards library to confirm there has been no subsequent revision or withdrawal before relying on it for procurement or regulatory work.

Q: Is it part of a series?

A: Yes. F139 sits among several ASTM material specifications for implant metallurgy (for example F138 for bar and wire, F1350 for surgical fixation wire, and various titanium and cobalt‑chromium alloy specifications). It is commonly used alongside general flat-rolled stainless-steel requirements (ASTM A480/A480M) and cross-referenced by international standards such as ISO 5832-1.

Q: What are the key keywords?

A: Key terms are UNS S31673, 18Cr-14Ni-2.5Mo, surgical implants, stainless steel sheet, stainless steel strip, austenitic stainless, corrosion resistance, tensile test, hardness test, intergranular corrosion.