ASTM F136-13 (2021)e1 PDF

Full title and description

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). This specification defines the chemical, mechanical, and metallurgical requirements for wrought, annealed Ti‑6Al‑4V ELI intended for manufacturing surgical implants and related medical devices.

Abstract

The standard covers permitted product forms (strip, sheet, plate, bar, forging bar, and wire), heat analysis and product analysis tolerances, mechanical testing requirements (tension and bend testing), and microstructural and metallurgical acceptance criteria for Ti‑6Al‑4V ELI (UNS R56401) used in surgical implant applications. It is intended to ensure material consistency, biocompatibility-related quality, and traceability for implant manufacturing.

General information

• Status: Designation ASTM F136‑13(2021)e1 — active designation with the e1 update published in 2021 (last updated Aug 19, 2021).
• Publication date: Original designation issued 11 January 2013; current designation includes the 2021 e1 amendment (update noted Aug 19, 2021).
• Publisher: ASTM International (American Society for Testing and Materials).
• ICS / categories: Medical devices / Implants for surgery (commonly indexed under implant/medical materials classifications such as ICS 11.040.40).
• Edition / version: F136‑13(2021)e1 (designation indicates the 2013 base standard with the 2021 e1 amendment).
• Number of pages: Short specification (approximately 5 pages in the ASTM publication).

Scope

This specification establishes the minimum chemical composition, mechanical property limits, and metallurgical quality requirements for wrought, annealed Ti‑6Al‑4V ELI (UNS R56401) intended specifically for surgical implant use. It applies to mill products supplied in forms such as strip, sheet, plate, bar, forging bar, and wire and includes requirements for heat analysis, product analysis tolerances, tension and bend testing, and acceptance criteria to assure suitability for implant manufacturing.

Key topics and requirements

• Chemical composition limits for Ti‑6Al‑4V ELI (UNS R56401) and permitted impurity/element ranges.
• Mechanical property requirements (tensile strength, yield, elongation) and mandatory tensile and bend testing procedures.
• Product classification and permissible product forms: strip, sheet, plate, bar, forging bar, and wire.
• Heat analysis and product analysis tolerances to account for laboratory measurement variation while maintaining specified limits.
• Metallurgical acceptance criteria and microstructure considerations for implant-grade performance.
• Requirements for marking, certification and batch traceability suitable for medical device supply chains.

Typical use and users

Primary users are medical device OEMs (orthopedic, dental, spinal and trauma implant manufacturers), materials and metallurgical engineers, implant component suppliers, quality and regulatory teams, and test laboratories that verify composition and mechanical performance for devices intended for implantation. The specification is used during material procurement, incoming inspection, supplier qualification, and device design material selection.

Related standards

Commonly referenced companion or alternative standards include ASTM F67 (unalloyed titanium for surgical implants), ASTM F1108 (Ti‑6Al‑4V castings for surgical implants), ASTM F1472 (wrought Ti‑6Al‑4V, non‑ELI), ASTM F1341 (unalloyed titanium wire for surgical implants), ASTM F1295 (Ti‑6Al‑7Nb), and various ASTM B-series product standards for titanium mill products (for example B348 for bars and billets). These related standards help users select the appropriate titanium grade and product form for specific implant applications.

Keywords

ASTM F136, Ti‑6Al‑4V ELI, UNS R56401, surgical implants, implant-grade titanium, chemical composition, tensile test, bend test, biocompatibility, traceability.

FAQ

Q: What is this standard?

A: ASTM F136‑13(2021)e1 is the ASTM standard specification that sets the minimum chemical, mechanical, and metallurgical requirements for wrought, annealed Ti‑6Al‑4V ELI (UNS R56401) used in surgical implant applications.

Q: What does it cover?

A: It covers permitted product forms (strip, sheet, plate, bar, forging bar, wire), required heat and product analyses, mechanical testing (tension and bend), metallurgical acceptance criteria, and requirements for material certification and traceability for implant manufacturing.

Q: Who typically uses it?

A: Implant manufacturers, material suppliers, device designers, quality/regulatory engineers, and testing laboratories working in orthopedic, dental, spinal, and trauma device fields use this specification to specify and verify implant-grade Ti‑6Al‑4V ELI material.

Q: Is it current or superseded?

A: The designation F136‑13(2021)e1 reflects the 2013 base standard with an e1 update in 2021 (last noted update Aug 19, 2021). Users should confirm with ASTM or their national standards body for the very latest revision activity; a work item for revision has been recorded for future updates.

Q: Is it part of a series?

A: It is part of the family of ASTM medical titanium specifications maintained by committee F04 (medical and surgical materials and devices) and is commonly used alongside other ASTM titanium standards (for example F67, F1108, F1472) when specifying implant materials.

Q: What are the key keywords?

A: Ti‑6Al‑4V, ELI, UNS R56401, surgical implants, implant-grade titanium, chemical composition, tensile properties, bend test, material certification, traceability.