EN ISO 13356:2015

SLOVENSKI STANDARD
01-december-2015
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SIST EN ISO 13356:2013
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Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-
TZP) (ISO 13356:2015)
Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem
Zirkon (Y-TZP) (ISO 13356:2015)
Implants chirurgicaux - Produits céramiques à base de zircone tétragonal stabilisée à
l'yttrium (Y-TZP) (ISO 13356:2015)
Ta slovenski standard je istoveten z: EN ISO 13356:2015
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 13356
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 13356:2013
English Version
Implants for surgery - Ceramic materials based on yttria-
stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)
Implants chirurgicaux - Produits céramiques à base de Chirurgische Implantate - Keramische Werkstoffe aus
zircone tétragonal stabilisée à l'yttrium (Y-TZP) (ISO yttriumstabilisiertem tetragonalem Zirkonium (Y-TZP)
13356:2015) (ISO 13356:2015)
This European Standard was approved by CEN on 22 August 2015.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13356:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 13356:2015) has been prepared by Technical Committee
ISO/TC 106 “Dentistry” 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 March 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.
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.
This document supersedes EN ISO 13356:2013.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13356:2015 has been approved by CEN as EN ISO 13356:2015 without any modification.

INTERNATIONAL ISO
STANDARD 13356
Third edition
2015-09-15
Implants for surgery — Ceramic
materials based on yttria-stabilized
tetragonal zirconia (Y-TZP)
Implants chirurgicaux — Produits céramiques à base de zircone
tétragonal stabilisée à l’yttrium (Y-TZP)
Reference number
ISO 13356:2015(E)
©
ISO 2015
ISO 13356:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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.
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ii © ISO 2015 – All rights reserved

ISO 13356:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Physical and chemical properties . 2
3.1 Test category . 2
3.1.1 General. 2
3.1.2 Category 1 . 2
3.1.3 Category 2 . 2
4 Test methods . 4
4.1 General . 4
4.2 Bulk density . 4
4.3 Chemical composition . 4
4.4 Microstructure . 4
4.4.1 Principle . 4
4.4.2 Test report . 5
4.4.3 Amount of monoclinic phase . 5
4.5 Biaxial flexural strength . 6
4.5.1 Principle . 6
4.5.2 Apparatus . 6
4.5.3 Preparation of test specimens . 6
4.5.4 Procedure . 7
4.5.5 Calculation of results . 8
4.5.6 Test report . 8
4.6 Four-point bending strength . 8
4.7 Weibull modulus . 9
4.8 Young’s modulus . 9
4.9 Hardness . 9
4.10 Cyclic fatigue . 9
4.10.1 Principle . 9
4.10.2 Apparatus . 9
4.10.3 Sample size and preparation of test specimens . 9
4.10.4 Procedure and sample requirement . 9
4.10.5 Test Report .10
4.11 Radioactivity .10
4.11.1 Principle .10
4.11.2 Apparatus .10
4.11.3 Sample preparation .11
4.11.4 Isotope identification - Energy calibration .11
4.11.5 Quantitative analysis .11
4.11.6 Expression of results .12
4.11.7 Test report .12
4.12 Accelerated aging test .12
4.12.1 General.12
4.12.2 Procedure .12
4.12.3 Evaluation of ac
...