DIN Standards Committee Dentistry
DIN EN ISO 5832-3
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2016); German version EN ISO 5832-3:2016
Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierung (ISO 5832-3:2016); Deutsche Fassung EN ISO 5832-3:2016
Overview
Titanium alloys are used in the aerospace and medical industries. In general surgery, titanium and other materials are used for endo-implants (for example for hip, knee and shoulder joints) and in dentistry. In the year 2015 more than one million dental implants were inserted in Germany. Around 200,000 endo implants were implanted in hospitals. Over 90 % of dental implants are made of a special titanium alloy. This titanium alloy is sometimes referred to as titanium grade 5 or titanium grade 21 (ELI, lower limits for O and Fe). This part of ISO 5832 describes the properties and test methods for the wrought titanium alloy known as titanium 6-aluminum 4-vanadium alloy (Ti 6-Al 4-V alloy) used in the manufacture of implants. This International Standard has been prepared by ISO/TC 150/SC 1/WG 4 "Mechanical testing" (Secretariat: ANSI, USA) together with CEN/TC 55 "Dentistry" (Secretariat: DIN). The DIN-NADENT Working Committee NA 014-00-21 AA "Dental implants" is responsible. This standard replaces DIN EN ISO 5832-3:2012 and specifies requirements for the chemical composition (for example, limiting contents for iron, oxygen, carbon, and nitrogen), the microstructure and the mechanical properties (tensile strength, yield strength, elongation at break, bending). Titanium spontaneously forms a thin oxide layer on contact with air, water or body fluids. This compact and homogeneous passivation protects the titanium, which is the basis for its excellent corrosion resistance and biocompatibility. The standard specifies globally uniform quality requirements for the raw material from which dental implants are machined. It is therefore used by the purchasing department when ordering to define specifications and by the supplier of the titanium alloy for the works certificate that is issued for each batch produced.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 014-00-21 AA - Dental implants