ISO 5832-3:2021
Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 8
- Дата публикации:
- 18 ноября 2021 г.
- Издание:
- ISO IS 5832 edition 5 version 1
- ICS:
- 11.040.40
This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti-6Al-4V alloy) for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with the specifications given in this document.
Abstract
Overview
ISO 5832-3:2021 - "Implants for surgery - Metallic materials - Part 3: Wrought titanium 6‑aluminium 4‑vanadium alloy (Ti‑6Al‑4V)" - specifies the chemical, microstructural and mechanical characteristics, and the corresponding test methods, for wrought Ti‑6Al‑4V used in the manufacture of surgical implants. The standard applies to raw implant material; mechanical properties of finished devices may differ from the raw‑material values.
Keywords: ISO 5832-3:2021, Ti-6Al-4V, wrought titanium, surgical implants, implant materials, biomaterials.
Key topics and requirements
- Chemical composition
- Aluminium: 5.5–6.75%
- Vanadium: 3.5–4.5%
- Iron: ≤ 0.30%
- Oxygen: ≤ 0.20%
- Carbon: ≤ 0.08%
- Nitrogen: ≤ 0.05%
- Hydrogen: ≤ 0.015% (≤ 0.010% for billets)
- Titanium: balance
- Microstructure
- Acceptable microstructure: equiaxed alpha or elongated primary alpha in a transformed beta matrix with no continuous alpha network at prior beta grain boundaries.
- Transverse microstructures for round bars (annealed condition) are referenced to photomicrographs in ISO 20160 (A1–A9).
- Mechanical properties (annealed condition)
- Tensile strength (Rm): ≥ 860 MPa
- Proof/yield strength (Rp0.2): ≥ 780 MPa
- Elongation after fracture: ≥ 8% for sheet/strip, ≥ 10% for bars
- Bend test: sheet/strip must withstand bending (105°) around a mandrel specified as 10 × t (t = thickness)
- Test methods
- Tensile tests: ISO 6892-1
- Bend tests: ISO 7438
- Microstructure classification: ISO 20160
- Conformity & retest rules
- Retest procedures and pass/fail criteria are defined (including provisions if failures occur inside/outside gauge length).
Applications and users
- Practical use: provides material requirements for manufacturers of surgical implants (e.g., orthopaedic and dental implant components), raw material suppliers, medical device OEMs, quality assurance and testing laboratories, and regulators verifying material conformity.
- Why it matters: ensures consistent biocompatible, high‑strength, corrosion‑resistant wrought Ti‑6Al‑4V raw material suitable for surgical implant fabrication and global trade.
Related standards
- ISO 6892-1 - Tensile testing of metallic materials
- ISO 7438 - Bend test for metallic materials
- ISO 20160 - Microstructure catalog for alpha+beta Ti alloys
- ASTM F136 / F1472 - Harmonization tables and reference specifications for Ti‑6Al‑4V (ELI and non‑ELI grades) - summarized in Annex B of ISO 5832-3:2021
For manufacturers and material engineers, ISO 5832-3:2021 is a key reference when specifying wrought Ti‑6Al‑4V raw stock and when aligning material test reports with global implant‑material requirements.
Технические детали
- Технический комитет
- ISO/TC 150/SC 1 - Materials
- SKU
- ISO 5832-3:2021
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