ISO 5832-11:2024

Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy

This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6Al-7Nb) for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.

Implants chirurgicaux — Produits à base de métaux — Partie 11: Alliage à forger à base de titane, d'aluminium 6 et de niobium 7

General Information

• Status: Published
• Publication Date: 19-Mar-2024
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 1 - Materials
• Drafting Committee: ISO/TC 150/SC 1 - Materials
• Current Stage: 6060 - International Standard published
• Start Date: 20-Mar-2024
• Due Date: 17-Sep-2024
• Completion Date: 20-Mar-2024

Relations

• Revises: ISO 5832-11:2014 - Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
• Effective Date: 06-Jun-2022

Overview

ISO 5832-11:2024 specifies the chemical, microstructural and mechanical requirements and associated test methods for wrought titanium 6‑aluminium 7‑niobium alloy (Ti‑6Al‑7Nb) intended for the manufacture of surgical implants. This third edition updates composition and mechanical testing language and harmonizes the document within the ISO 5832 series. The standard covers raw material characteristics and test procedures but does not replace device‑level design, fabrication or biocompatibility assessment-mechanical properties of finished implants can differ from the raw material values given.

Key topics and requirements

• Chemical composition: Defined mass fraction limits include Aluminium 5.5–6.5%, Niobium 6.5–7.5%, Tantalum ≤0.50%, Iron ≤0.25%, Oxygen ≤0.20%, Carbon ≤0.08%, Nitrogen ≤0.05%, Hydrogen ≤0.009%, with Titanium as the balance. Hydrogen must be determined after heat treatment and pickling when required.
• Microstructure: The alloy must exhibit a uniform, globular or elongated globular alpha phase in a transformed beta matrix with no continuous alpha network at prior beta grain boundaries. Transverse microstructure of annealed round bars must match photomicrographs A1–A9 in ISO 20160:2006.
• Mechanical properties (annealed condition): Specified minimums include tensile strength Rm ≥ 900 MPa, proof (0.2%) or yield strength ≥ 800 MPa, minimum elongation after fracture ≥ 10%, and reduction of area ≥ 25% (for bars up to 100 mm).
• Test methods: Mechanical testing follows ISO 6892‑1 (tensile testing at room temperature); microstructure classification follows ISO 20160; recognized analytical procedures apply for chemical analysis. The standard defines retest procedures for failed specimens and allows re‑heat treatment and re‑submission by the manufacturer.

Applications and who uses it

ISO 5832‑11 is used by:

• Medical implant manufacturers specifying Ti‑6Al‑7Nb raw materials for surgical components.
• Materials and process engineers responsible for metallurgical verification, heat treatment and quality control.
• Testing laboratories and conformity assessors conducting chemical, microstructural and tensile tests to demonstrate compliance.
• Regulatory, procurement and quality assurance teams who need traceable material specifications for implantable devices.

Typical practical applications include components for orthopaedic and dental implants, fixation devices and other load‑bearing surgical implants where a titanium alpha+beta alloy is required.

Related standards

• ISO 6892‑1 - Metallic materials - Tensile testing (room temperature)
• ISO 20160:2006 - Classification of microstructures for alpha+beta titanium alloy bars
• Other parts of the ISO 5832 series covering metallic materials for surgical implants

Keywords: ISO 5832‑11, Ti‑6Al‑7Nb, titanium 6‑aluminium 7‑niobium, implants for surgery, wrought titanium alloy, medical implant materials, mechanical properties, microstructure, test methods.

Standards Content (Sample)

International
Standard
ISO 5832-11
Third edition
Implants for surgery — Metallic
2024-03
materials —
Part 11:
Wrought titanium 6-aluminium
7-niobium alloy
Implants chirurgicaux — Produits à base de métaux —
Partie 11: Alliage à forger à base de titane, d'aluminium 6 et de
niobium 7
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Chemical composition . 1
5 Microstructure. 2
6 Mechanical properties . 2
7 Test methods . 2

iii
Foreword
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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC
1, Metals.
This third edition cancels and replaces the second edition (ISO 5832-11:2014), which has been technically
revised.
The main changes are as follows:
— the introduction has been updated;
— Clause 4 on chemical comp
...