EN ISO 13356:2013

SLOVENSKI STANDARD
01-september-2013
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Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-
TZP) (ISO 13356:2008)
Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem
Zirkondioxid (Y-TZP) (ISO 13356:2008)
Implants chirurgicaux - Produits céramiques à base de zircone tétragonal stabilisé à
l'oxyde d'yttrium (Y-TZP) (ISO 13356:2008)
Ta slovenski standard je istoveten z: EN ISO 13356:2013
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.

EUROPEAN STANDARD
EN ISO 13356
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2013
ICS 11.040.40
English Version
Implants for surgery - Ceramic materials based on yttria-
stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2008)
Implants chirurgicaux - Produits céramiques à base de Chirurgische Implantate - Keramische Werkstoffe aus
zircone tétragonal stabilisé à l'oxyde d'yttrium (Y-TZP) (ISO yttriumstabilisiertem tetragonalem Zirkondioxid (Y-TZP)
13356:2008) (ISO 13356:2008)
This European Standard was approved by CEN on 28 March 2013.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13356:2013: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO 13356:2008 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 13356:2013 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 October 2013, and conflicting national standards shall be withdrawn at
the latest by October 2013.
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, 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 13356:2008 has been approved by CEN as EN ISO 13356:2013 without any modification.

INTERNATIONAL ISO
STANDARD 13356
Second edition
2008-06-01
Implants for surgery — Ceramic materials
based on yttria-stabilized tetragonal
zirconia (Y-TZP)
Implants chirurgicaux — Produits céramiques à base de zircone
tétragonal stabilisé à l'oxyde d'yttrium (Y-TZP)

Reference number
ISO 13356:2008(E)
©
ISO 2008
ISO 13356:2008(E)
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ii © ISO 2008 – All rights reserved

ISO 13356:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Normative references .1
3 Physical and chemical properties.2
4 Test methods.3
4.1 Bulk density.3
4.2 Chemical composition .3
4.3 Microstructure.3
4.4 Biaxial flexural strength .6
4.5 Four-point bending strength .9
4.6 Cyclic fatigue.9
4.7 Radioactivity.10
4.8 Accelerated Aging Test.12
Bibliography .13

ISO 13356:2008(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. 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.
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.
ISO 13356 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials.
This second edition cancels and replaces the first edition (ISO 13356:1997) which has been technically
revised.
iv © ISO 2008 – All rights reserved

ISO 13356:2008(E)
Introduction
No known surgical implant material has ever been shown to cause absolutely no adverse reactions in the
human body. However, long-term clinical experience of the use of the material referred to in this International
Standard has shown that an acceptable level of biological response can be expected when the material is
used in appropriate applications.

INTERNATIONAL STANDARD ISO 13356:2008(E)

Implants for surgery — Ceramic materials based on
yttria-stabilized tetragonal zirconia (Y-TZP)
1 Scope
This International Standard specifies the characteristics of, 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 material for surgical implants.
2 Normative references
The following referenced documents are indispensable for the application 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 3611, Micrometer callipers for external measurement
ISO 7500-1:2004, Metallic materials — Verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Verification and calibration of the force-measuring system
ISO 14704, Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for flexural
strength of monolithic ceramics at room temperature
ISO 18754, Fine ceramics (advanced ceramics, advanced technical ceramics) — Determination of density
and apparent porosity
EN 623-2, Advanced technical ceramics — Monolithic ceramics — General and textural properties — Part 2:
Determination of density and porosity
EN 623-3, Advanced technical ceramics — Monolithic ceramics — General and textural properties — Part 3:
Determination of grain size and size distribution (characterized by the Linear Intercept Method)
ASTM C1499, Standard Test Method for Monotonic Equibiaxial Flexural Strength of Advanced Ceramics at
Ambient Temperature
ASTM E112-96, Standard Test Methods for Determining Average Grain Size
ASTM G136-03, Standard Practice for Determination of Soluble Residual Contaminants in Materials by
Ultrasonic Extraction
1)
ASTM F1873-98 , Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide
Polycrystal (Y-TZP) for Surgical Implant Applications

1) Standard since withdrawn.
ISO 13356:2008(E)
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.
Table 1 — Limits for material properties
Test method according to
Property Unit Requirement
subclause
Bulk density g/cm W 6,00 4.1
Chemical composition:
ZrO + HfO + Y O W 99,0
2 2 2 3
Y O > 4,5 to u 6,0
2 3
percent mass fraction 4.2
HfO u 5
Al O u 0,5
2 3
Other oxides u 0,5
Microstructure:
µm Intercept distance u 0,4 4.3
grain size
Microstructure:
Standard deviation < 0,18
amount of monoclinic 4.3.7
u 20 %
phase
a
Strength :
W 500 4.4
MPa
biaxial flexure or
W 800 4.5
4-point bending
Cyclic fatigue limit stress at
MPa W 320 4.6
10 cycles
b
Radioactivity Bq/kg u 200 4.7
Accelerated aging:
maximum amount of
u 25 %
monoclinic phase
after accelerated
aging
4.8
W 500 MPa, and decrease
residual biaxial flexure
not more than 20 %
s
...