SIST 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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
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 accelerated aging outcome .12
Bibliography .13
ISO 13356:2015(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary Information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee
SC 1, Materials.
This third edition cancels and replaces the second edition (ISO 13356:2008), which has been
technically revised.
iv © ISO 2015 – All rights reserved

ISO 13356:2015(E)
Introduction
No known surgical implant material has ever been found to cause absolutely no adverse reactions in
the human body. However, long-term clinical experience regarding the use of the material referred to in
this International Standard has shown that an acceptable level of biological response can be expected if
the material will be used in appropriate applications.
INTERNATIONAL STANDARD ISO 13356:2015(E)
Implants for surgery — Ceramic materials based on yttria-
stabilized tetragonal zirconia (Y-TZP)
1 Scope
This International Standard specifies the requirements and corresponding test methods for a
biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal
zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as a material for surgical implants.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 3310-1, Test sieves — Technical requirements and testing — Part 1: Test sieves of metal wire cloth
ISO 3611, Geometrical product specifications (GPS) — Dimensional measuring equipment: Micrometers for
external measurements — Design and metrological characteristics
ISO 7500-1, Metallic materials — Verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Verification and calibration of the force-measuring system
ISO 13383-1, Fine ceramics (advanced ceramics, advanced technical ceramics) — Microstructural
characterization — Part 1: Determination of grain size and size distribution
ISO 14704, Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for flexural
strength of monolithic ceramics at room temperature
ISO 14705, Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for hardness of
monolithic ceramics at room temperature
ISO 17561, Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for elastic moduli
of monolithic ceramics at room temperature by sonic resonance
ISO 18754, Fine ceramics (advanced ceramics, advanced technical ceramics) — Determination of density
and apparent porosity
ISO 20501, Fine ceramics (advanced ceramics, advanced technical ceramics) — Weibull statistics for
strength data
ISO 22214, Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for cyclic
bending fatigue of monolithic ceramics at room temperature
EN 623-2, Advanced technical ceramics — Monolithic ceramics — General and textural properties —
Part 2: Determination of density and porosity
EN 843-2, Advanced technical ceramics — Mechanical properties of monolithic ceramics at room
temperature — Part 2: Determination of Young’s modulus, shear modulus and Poisson’s ratio
EN 843-4, Advanced technical ceramics — Mechanical properties of monolithic ceramics at room
temperature — Part 4: Vickers, Knoop and Rockwell superficial hardness
EN 843-5, Advanced technical ceramics — Mechanical properties of monolithic ceramics at room
temperature — Part 5: Statistical analysis
ISO 13356:2015(E)
ASTM C1161, Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
ASTM C1198, Standard Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for
Advanced Ceramics by Sonic Resonance
ASTM C1239, Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution
Parameters for Advanced Ceramics
ASTM C1259, Standard Test method for Dynamic Young’s Modulus. Shear Modulus, and Poisson’s Ratio for
Advanced Ceramics by Impulse Excitation of Vibration
ASTM C1327, Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics
ASTM C1331, Standard Test Method for Measuring Ultrasonic Velocity in Advanced Ceramics with
Broadband Pulse-Echo Cross-Correlation Method
ASTM E112, Standard Test Method for Determining Average Grain Size
3 Physical and chemical properties
The physical and chemical properties, when tested as specified in Clause 4, shall comply with the values
specified in Table 1.
3.1 Test category
3.1.1 General
The required tests are divided into two categories.
3.1.2 Category 1
The following test shall be performed for periodical production control:
a) bulk density;
b) chemical composition;
c) microstructure;
d) strength (including Weibull modulus);
e) accelerated aging (monoclinic fraction).
3.1.3 Category 2
The manufacturer shall define the general materials specification. In addition to all tests in 3.1.2, the
following tests shall be performed to demonstrate compliance with the material specification:
a) hardness;
b) Young’s modulus;
c) fatigue strength;
d) accelerated aging (strength);
e) quantity of monoclinic phase;
f) radioactivity.
2 © ISO 2015 – All rights reserved

ISO 13356:2015(E)
Table 1 — Limits for material properties
Test
Property Unit Requirement Reference Subclause
category
ISO 18754
Bulk density g/cm 1 ≥ 6,00 4.2
EN 623–2
Chemical composition 4.3
a
ZrO +HfO +Y O ≥ 99,0
2 2 2 3
Y O > 4,5 to ≤ 6,0
2 3
% mass
HfO 1 ≤ 5
fraction
Al O ≤ 0,5
2 3
Other oxides ≤ 0,5
Microstructure 4.4
Intercept distance ≤ 0,4
ISO 13383-1
Grain size μm 1
ASTM E112
Standard deviation < 0,2
% molar
Amount of monoclinic phase 2 ≤ 20 See 4.4.3
fraction
Strength: alternative of 1)
or 2)
a
1a) Biaxial flexure 1 ≥ 500 ASTM C1499 4.5
ISO 20501
1b) Weibull modulus 1 ≥ 8 EN 843–5
...