ISO 5832-11:2024

Name: ISO 5832-11:2024 — Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
SKU: ISO 5832-11:2024
Price: 5400 RUB
Availability: InStock

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

Название (английский):

ISO 5832-11:2024

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 3
Дата публикации:: 20 марта 2024 г.
Издание:: ISO IS 5832 edition 3 version 1
ICS:: 11.040.40

Тип поставки:

Full version5 400 ₽Read online 24h1 200 ₽Read online 72h1 800 ₽

Язык документа:

ruen

Срок поставки:1 раб. дн. (перевод)

Цена:5 400 ₽

Описание (английский):

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.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

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

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.

ISO 5832-11:2024

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and who uses it

Related standards

Технические детали

ISO 20160:2006

Implants for surgery — Metallic materials — Classification of microstructures for alpha+beta titanium alloy b…

SIST EN ISO 6892-1:2020

Metallic materials - Tensile testing - Part 1: Method of test at room temperature (ISO 6892-1:2019)

ISO 8689-1:2000

Water quality — Biological classification of rivers — Part 1: Guidance on the interpretation of biological qu…

ISO/ASTM51540-04(2012)

Standard Practice for Use of a Radiochromic Liquid Dosimetry System (Withdrawn 2020)

ISO/ASTM51204-04

Standard Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing (Withdrawn 2013)

ISO/ASTM51431-05

Standard Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food P…

ISO/ASTM52628-20e1

Standard Practice for Dosimetry in Radiation Processing

ISO/ASTM52921-13(2019)

Standard Terminology for Additive Manufacturing—Coordinate Systems and Test Methodologies