SIST EN ISO 5832-3:2012
(Main)Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996)
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996)
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti 6-AI 4-V alloy) for use in the manufacture of surgical implants.
Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierungen (ISO 5832-3:1996)
Dieser Teil von ISO 5832 beschreibt Eigenschaften und dazugehörige Prüfverfahren für Titan-Knetlegierungen, die als Titan 6-Aluminium 4-Vanadium-Legierungen (Ti 6-Al 4-V-Legierungen) bekannt sind, und zur Herstellung von chirurgischen Implantaten verwendet werden.
ANMERKUNG Die mechanischen Eigenschaften einer Probe, die von einem Fertigprodukt aus diesem Metall entnommen wurden, müssen nicht notwendigerweise mit denen in diesem Teil von ISO 5832 angegebenen übereinstimmen.
Implants chirurgicaux - Produits à base de métaux - Partie 3: Alliage à forger à base de titane, d'aluminium 6 et de vanadium 4 (ISO 5832-3:1996)
Vsadki (implantati) za kirurgijo - Kovinski materiali - 3. del: Kovana zlitina (ISO 5832-3:1996)
Ta del standarda ISO 5832 določa lastnosti in zadevne preskusne metode za kovano titanovo zlitino, znano kot zlitina Ti 6-AI 4-V, iz katere izdelujejo vsadke za kirurgijo.
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SLOVENSKI STANDARD
SIST EN ISO 5832-3:2012
01-oktober-2012
Vsadki (implantati) za kirurgijo - Kovinski materiali - 3. del: Kovana zlitina (ISO
5832-3:1996)
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-
vanadium alloy (ISO 5832-3:1996)
Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-Vanadium
Knetlegierungen (ISO 5832-3:1996)
Implants chirurgicaux - Produits à base de métaux - Partie 3: Alliage à forger à base de
titane, d'aluminium 6 et de vanadium 4 (ISO 5832-3:1996)
Ta slovenski standard je istoveten z: EN ISO 5832-3:2012
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
77.120.50 Titan in titanove zlitine Titanium and titanium alloys
SIST EN ISO 5832-3:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5832-3:2012
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SIST EN ISO 5832-3:2012
EUROPEAN STANDARD
EN ISO 5832-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2012
ICS 11.040.40
English Version
Implants for surgery - Metallic materials - Part 3: Wrought
titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996)
Implants chirurgicaux - Produits à base de métaux - Partie Chirurgische Implantate - Metallische Werkstoffe - Teil 3:
3: Alliage à forger à base de titane, d'aluminium 6 et de Titan 6-Aluminium 4-Vanadium Knetlegierungen (ISO
vanadium 4 (ISO 5832-3:1996) 5832-3:1996)
This European Standard was approved by CEN on 28 April 2012.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5832-3:2012: E
worldwide for CEN national Members.
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SIST EN ISO 5832-3:2012
EN ISO 5832-3:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 5832-3:2012
EN ISO 5832-3:2012 (E)
Foreword
The text of ISO 5832-3:1996 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 5832-3:2012 by
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 2012, and conflicting national standards shall be withdrawn
at the latest by November 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 5832-3:1996 has been approved by CEN as a EN ISO 5832-3:2012 without any modification.
3
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SIST EN ISO 5832-3:2012
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SIST EN ISO 5832-3:2012
INTERNATIONAL
ISO
STANDARD 5832-3
Third edition
1996-07-01
lmplants for surgery - Metallic materials -
Part 3:
Wrought titanium 6-aluminium 4-vanadium alloy
Implants chirurgicaux - Produits à base de métaux -
Partie 3: Alliage à forger à base de titane, d’aluminium 6 et de vanadium 4
Reference number
ISO 5832-3 : 1996(E)
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SIST EN ISO 5832-3:2012
ISO 5832-3: 1996(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide
federation of national standards bodies (60 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 rep-
resented 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.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard ISO 5832-3 was prepared by Technical Committee
ISO/TC 150, Implants for surgery, Subcommittee SC 1, M&eria/s.
This third edition cancels and replaces the second edition
(ISO 5832-3:1990), which has been technically revised.
ISO 5832 consists of the following parts, under the general title Implants
for surgery - Me tallic ma terials:
- Part 7: Wrought stainless steel
- P
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierungen (ISO 5832-3:1996, einschließlich Änderung 1:2011)Implants chirurgicaux - Produits à base de métaux - Partie 3: Alliage à forger à base de titane, d'aluminium 6 et de vanadium 4 (ISO 5832-3:1996, y compris Amd 1:2011)Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996 including Amd 1:2011)77.120.50Titan in titanove zlitineTitanium and titanium alloys11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:FprEN ISO 5832-3kSIST FprEN ISO 5832-3:2012en01-februar-2012kSIST FprEN ISO 5832-3:2012SLOVENSKI
STANDARD
kSIST FprEN ISO 5832-3:2012
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 5832-3
October 2011 ICS 11.040.40 English Version
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996 including Amd 1:2011)
Implants chirurgicaux - Produits à base de métaux - Partie 3: Alliage à forger à base de titane, d'aluminium 6 et de vanadium 4 (ISO 5832-3:1996, y compris Amd 1:2011)
Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierungen (ISO 5832-3:1996, einschließlich Änderung 1:2011) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 55.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 5832-3:2011: EkSIST FprEN ISO 5832-3:2012
FprEN ISO 5832-3:2011 (E) 2 Contents Page Foreword .3 kSIST FprEN ISO 5832-3:2012
FprEN ISO 5832-3:2011 (E) 3 Foreword The text of ISO 5832-3:1996 including Amd 1:2011 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 5832-3:2011 by Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. Endorsement notice The text of ISO 5832-3:1996 including Amd 1:2011 has been approved by CEN as a FprEN ISO 5832-3:2011 without any modification.
kSIST FprEN ISO 5832-3:2012
kSIST FprEN ISO 5832-3:2012
INTERNATIONAL STANDARD ISO 5832-3 Third edition 1996-07-01 lmplants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy Implants chirurgicaux - Produits à base de métaux - Partie 3: Alliage à forger à base de titane, d’aluminium 6 et de vanadium 4 Reference number ISO 5832-3 : 1996(E) kSIST FprEN ISO 5832-3:2012
ISO 5832-3: 1996(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (60 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 rep- resented 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. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 5832-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, M&eria/s. This third edition cancels and replaces the second edition (ISO 5832-3:1990), which has been technically revised. ISO 5832 consists of the following parts, under the general title Implants for surgery - Me tallic ma terials: - Part 7: Wrought stainless steel - Part 2: Unalloyed titanium - Part 3: Wrought titanium 6-aluminium 4-vanadium allo y - Part 4: Cobalt-chromium-molybdenum casting alloy - Part 5: Wrough t cobalt-chromium-tungsten-nickel allo y - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molyb- denum-iron allo y - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy 0 ISO 1996 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case postale 56 l CH-l 211 Genève 20 l Switzerland Printed in Switzerland ii kSIST FprEN ISO 5832-3:2012
@ ISO ISO 5832-3: 1996(E) - Part 9: Wrough t high nitrogen stainless steel - Part 7 0: Wrough t titanium 5-aluminium 2,5-iron alloy - Part 17: Wrought titanium 6-aluminium 7-niobium alloy - Part 12: Wrough t cobalt-chromium-molybdenum allo y . . . III kSIST FprEN ISO 5832-3:2012
ISO 5832-3: 1996(E) @ ISO Introduction No known surgical implant material has ever been shown to cause absol- utely no adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in this part of ISO 5832 has shown that an acceptable level of biological response cari be expected, when the material is used in appropriate applications. iv kSIST FprEN ISO 5832-3:2012
INTERNATIONAL STANDARD @ ISO ISO 5832-3: 1996(E) Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy 1 Scope This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti 6-AI 4-V alloy) for use in the manufacture of surgical implants. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy may not necess- arily comply with the specifications given in this part of ISO 5832. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 5832. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 5832 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 6892:1984, Metallic materials - Tensile testing. ISO 7438:1985, Metallic materials - Bend test. ETTU Publication 2, 1979, Microstructural standards for cc + p titanium alloy bars? 3 Chemical compos
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