SIST EN ISO 5832-2:2018

Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)

This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium
for use in the manufacture of surgical implants.
Six grades of titanium based on tensile strength are listed in Table 2.
NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not
necessarily comply with those specified in this document.

Chirurgische Implantate - Metallische Werkstoffe - Teil 2: Unlegiertes Titan (ISO 5832-2:2018)

Dieser Teil von ISO 5832 beschreibt die Eigenschaften und die dazugehörige Prüfverfahren für unlegiertes Titan, das zur Herstellung von chirurgischen Implantaten verwendet wird.
Es werden Festlegungen für sechs verschiedene Titan-Güten auf der Basis der Zugfestigkeit getroffen (siehe Tabelle 2).
ANMERKUNG Die mechanischen Eigenschaften einer Probe, die von einem Fertigprodukt aus diesem Metall werden, müssen nicht notwendigerweise mit den Angaben in diesem Teil von ISO 5832 übereinstimmen.

Implants chirurgicaux - Produits à base de métaux - Partie 2: Titane non allié (ISO 5832-2:2018)

L'ISO 5832-2:2018 spécifie les caractéristiques du titane non allié utilisé pour la fabrication des implants chirurgicaux et les méthodes d'essai correspondantes.
Le Tableau 2 répertorie six nuances de titane fondées sur la résistance à la traction.
NOTE       Les caractéristiques mécaniques d'un échantillon prélevé sur un produit fini fabriqué avec ce métal ne sont pas nécessairement conformes aux valeurs spécifiées dans l'ISO 5832-2:2018.

Vsadki (implantati) za kirurgijo - Kovinski materiali - 2. del: Nelegirani titan (ISO 5832-2:2018)

Ta dokument določa lastnosti in zadevne preskusne metode za nelegirani titan, ki se uporablja pri izdelavi vsadkov za kirurgijo.
V preglednici 2 je navedenih šest stopenj natezne trdnosti titana.
OPOMBA: mehanske lastnosti vzorca končnega izdelka iz te kovine niso nujno v skladu z lastnostmi, ki so določene v tem dokumentu.

General Information

• Status: Published
• Public Enquiry End Date: 19-Mar-2017
• Publication Date: 11-Jun-2018
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 24-May-2018
• Due Date: 29-Jul-2018
• Completion Date: 12-Jun-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 5832-2:2018 - Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)

Relations

• Replaces: SIST EN ISO 5832-2:2012 - Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:1999)
• Effective Date: 01-Jul-2018
• Replaces: SIST EN ISO 5832-2:2012 - Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:1999)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5832-2:2018
01-julij-2018
1DGRPHãþD
SIST EN ISO 5832-2:2012
Vsadki (implantati) za kirurgijo - Kovinski materiali - 2. del: Nelegirani titan (ISO
5832-2:2018)
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)
Chirurgische Implantate - Metallische Werkstoffe - Teil 2: Unlegiertes Titan (ISO 5832-
2:2018)
Implants chirurgicaux - Produits à base de métaux - Partie 2: Titane non allié (ISO 5832-
2:2018)
Ta slovenski standard je istoveten z: EN ISO 5832-2:2018
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5832-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5832-2:2018

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SIST EN ISO 5832-2:2018


EN ISO 5832-2
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2018
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5832-2:2012
English Version

Implants for surgery - Metallic materials - Part 2:
Unalloyed titanium (ISO 5832-2:2018)
Implants chirurgicaux - Produits à base de métaux - Chirurgische Implantate - Metallische Werkstoffe - Teil
Partie 2: Titane non allié (ISO 5832-2:2018) 2: Unlegiertes Titan (ISO 5832-2:2018)
This European Standard was approved by CEN on 1 March 2018.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5832-2:2018 E
worldwide for CEN national Members.

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SIST EN ISO 5832-2:2018
EN ISO 5832-2:2018 (E)
Contents Page
European foreword . 3

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SIST EN ISO 5832-2:2018
EN ISO 5832-2:2018 (E)
European foreword
This document (EN ISO 5832-2:2018) 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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
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 5832-2:2012.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 5832-2:2018 has been approved by CEN as EN ISO 5832-2:2018 without any
modification.

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SIST EN ISO 5832-2:2018

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SIST EN ISO 5832-2:2018
INTERNATIONAL ISO
STANDARD 5832-2
Fourth edition
2018-03
Implants for surgery — Metallic
materials —
Part 2:
Unalloyed titanium
Implants chirurgicaux — Produits à base de métaux —
Partie 2: Titane non allié
Reference number
ISO 5832-2:2018(E)
©
ISO 2018

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SIST EN ISO 5832-2:2018
ISO 5832-2:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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SIST EN ISO 5832-2:2018
ISO 5832-2:2018(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 properties . 2
6.2 Bending properties . 2
7 Test methods . 3
© ISO 2018 – All rights reserved iii

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SIST EN ISO 5832-2:2018
ISO 5832-2:2018(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
...