EN ISO 5832-3:2021
(Main)Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
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.
Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierung (ISO 5832-3:2021)
Dieses Dokument legt die Eigenschaften und die dazugehörigen Prüfverfahren für die Titanknetlegierung fest, die als Titan 6 Aluminium 4 Vanadium Legierung (Ti 6Al 4V Legierung) bekannt ist und zur Herstellung von chirurgischen Implantaten verwendet wird.
ANMERKUNG Die mechanischen Eigenschaften einer Probe, die von einem Endprodukt aus dieser Legierung erhalten werden, müssen nicht notwendigerweise mit den Angaben in diesem Dokument übereinstimmen.
Implants chirurgicaux - Matériaux métalliques - Partie 3: Alliage corroyé à base de titane, d'aluminium-6 et de vanadium-4 (ISO 5832-3:2021)
Le présent document spécifie les caractéristiques de l’alliage corroyé à base de titane, connu sous le nom d’alliage de titane, d’aluminium-6 et de vanadium-4 (alliage Ti-6AI-4V) utilisable dans la fabrication d’implants chirurgicaux, et les méthodes d’essai correspondantes.
NOTE Les propriétés mécaniques d’un échantillon prélevé sur un produit fini fabriqué avec ce métal peuvent ne pas être nécessairement conformes aux valeurs spécifiées dans le présent document.
Vsadki (implantati) za kirurgijo - Kovinski materiali - 3. del: Titanova 6-aluminijeva 4-vanadijeva zlitina (ISO 5832-3:2021)
Ta dokument določa lastnosti in zadevne preskusne metode za titanovo zlitino, znano kot titanova 6-aluminijeva 4-vanadijeva zlitina (zlitina Ti-6Al-4V), iz katere izdelujejo vsadke za kirurgijo.
OPOMBA: Mehanske lastnosti vzorca končnega izdelka iz te zlitine niso nujno v skladu s specifikacijami v tem dokumentu.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2022
Nadomešča:
SIST EN ISO 5832-3:2017
Vsadki (implantati) za kirurgijo - Kovinski materiali - 3. del: Titanova 6-aluminijeva
4-vanadijeva zlitina (ISO 5832-3:2021)
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-
vanadium alloy (ISO 5832-3:2021)
Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-Vanadium
Knetlegierung (ISO 5832-3:2021)
Implants chirurgicaux - Matériaux métalliques - Partie 3: Alliage corroyé à base de titane,
d'aluminium-6 et de vanadium-4 (ISO 5832-3:2021)
Ta slovenski standard je istoveten z: EN ISO 5832-3:2021
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 5832-3
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5832-3:2016
English Version
Implants for surgery - Metallic materials - Part 3: Wrought
titanium 6-aluminium 4-vanadium alloy (ISO 5832-
3:2021)
Implants chirurgicaux - Matériaux métalliques - Partie Chirurgische Implantate - Metallische Werkstoffe - Teil
3: Alliage corroyé à base de titane, d'aluminium-6 et de 3: Titan 6-Aluminium 4-Vanadium Knetlegierung (ISO
vanadium-4 (ISO 5832-3:2021) 5832-3:2021)
This European Standard was approved by CEN on 30 October 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5832-3:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5832-3:2021) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2022, and conflicting national standards shall be
withdrawn at the latest by June 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 5832-3:2016.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 5832-3:2021 has been approved by CEN as EN ISO 5832-3:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 5832-3
Fifth edition
2021-11
Implants for surgery — Metallic
materials —
Part 3:
Wrought titanium 6-aluminium
4-vanadium alloy
Implants chirurgicaux — Matériaux métalliques —
Partie 3: Alliage corroyé à base de titane, d'aluminium-6 et de
vanadium-4
Reference number
ISO 5832-3:2021(E)
ISO 5832-3:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 5832-3:2021(E)
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
6.1 Tensile . 2
6.2 Bending . 3
7 Test methods . 3
Annex A (informative) Catalogues of metallographic micrographs of typical alpha+beta
titanium microstructures .5
Annex B (informative) Mechanical properties' harmonization between ISO and ASTM
wrought titanium 6-aluminium 4-vanadium implant material standards .6
Bibliography . 8
iii
ISO 5832-3:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 1, Materials, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 5832-3:2016), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— normative references have been updated;
— requirements for microstructure have been clarified in Clause 5;
— the pass/fail criteria for tensile testing of material properties have been clarified in 6.1;
— Table 3 on test methods has been updated;
— references to ISO 20160 and EN 3114-03 have been removed from Annex A.
A list of all parts in the ISO 5832 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 5832-3:2021(E)
Introduction
While no known surgical implant material has ever been shown to cause absolutely no adverse reactions
in the human body, long-term clinical experience with the material referred to in this document has
shown that an acceptable level of biological response can be expected when the material is used in
appropriate applications. However, this document covers the raw material and not finished medical
devices, where the design and fabrication of the device can impact biological response.
v
INTERNATIONAL STANDARD ISO 5832-3:2021(E)
Implants for surgery — Metallic materials —
Part 3:
Wrought titanium 6-aluminium 4-vanadium alloy
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 6892-1, Metallic materials — Tensile testing — Part 1: Method of test at room temperature
ISO 7438, Metallic materials — Bend test
ISO 20160, Implants for surgery — Metallic materials — Classification of microstructures for alpha+beta
titanium alloy bars
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 6892-1 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electro
...
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