EN ISO 13356:2013

Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2008)

ISO 13356:2008 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.

Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkondioxid (Y-TZP) (ISO 13356:2008)

Diese Internationale Norm legt die Eigenschaften und die dazugehörigen Prüfverfahren für ein biokompatibles und biostabiles keramisches Knochenersatzmaterial auf der Grundlage von yttriumstabi¬lisiertem tetragonalem Zirkondioxid (mit Yttrium teilstabi¬lisiertem, polykristallinem, tetragonalem Zirkondioxid, Y TZP) fest, das für chirurgische Implantate verwendet wird.

Implants chirurgicaux - Produits céramiques à base de zircone tétragonal stabilisé à l'oxyde d'yttrium (Y-TZP) (ISO 13356:2008)

L'ISO 13356:2008 spécifie les caractéristiques et les méthodes d'essai correspondantes des matériaux de biosubstitution osseuse, biocompatibles et biostables à base de zirconium tétragonal stabilisé à l'oxyde d'yttrium (polycristaux de zirconium tétragonal stabilisés à l'yttrium, Y-TZP), utilisés dans les matériaux constitutifs des implants chirurgicaux.

Vsadki (implantati) za kirurgijo - Keramični materiali na osnovi tetragonalnega cirkonija, stabiliziranega z itrijem (Y-TZP) (ISO 13356:2008)

Ta mednarodni standard določa lastnosti biozdružljivega in biostabilnega keramičnega materiala za kostne nadomestke na osnovi tetragonalnega cirkonija, stabiliziranega z itrijem, (z itrijem stabilizirani polikristal tetragonalnega cirkonija, Y-TZP) za uporabo kot material za kirurške vsadke ter ustrezne preskusne metode zanj.

General Information

• Status: Withdrawn
• Publication Date: 16-Apr-2013
• Withdrawal Date: 29-Sep-2015
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Sep-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 13356:2013 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2008)

Relations

• Replaced By: EN ISO 13356:2015 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13356:2013
01-september-2013
9VDGNLLPSODQWDWL]DNLUXUJLMR.HUDPLþQLPDWHULDOLQDRVQRYLWHWUDJRQDOQHJD
FLUNRQLMDVWDELOL]LUDQHJD]LWULMHP<7=3,62
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
SIST EN ISO 13356:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13356:2013

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SIST EN ISO 13356:2013


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.

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SIST EN ISO 13356:2013
EN ISO 13356:2013 (E)
Contents Page
Foreword .3

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SIST EN ISO 13356:2013
EN ISO 13356:2013 (E)
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.

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SIST EN ISO 13356:2013

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SIST EN ISO 13356:2013

INTERNATION
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