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CEN

EN ISO 13356:2015

(Main)

Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)

Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)

ISO 13356:2015 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.

Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkoniumoxid (Y-TZP) (ISO 13356:2015)

Diese Internationale Norm legt die Anforderungen und dazugehörigen Prüfverfahren für ein biokompatibles und biostabiles keramisches Knochenersatzmaterial auf der Grundlage von yttriumstabi-lisiertem tetragonalem Zirkoniumoxid (yttria tetragonal zirconia polycristal, Y TZP) fest, das als Material für chirurgische Implantate verwendet wird.

Implants chirurgicaux - Produits céramiques à base de zircone tétragonal stabilisée à l'yttrium (Y-TZP) (ISO 13356:2015)

L'ISO 13356:2015 spécifie les exigences et les méthodes d'essai correspondantes applicables aux matériaux de substitution osseuse, biocompatibles et biostables, à base de zircone tétragonale stabilisée à l'oxyde d'yttrium (polycristaux de zircone tétragonale stabilisée à l'yttrium, Y-TZP), utilisés en tant que matériaux constitutifs d'implants chirurgicaux.

Vsadki (implantati) za kirurgijo - Keramični materiali na osnovi tetragonalnega cirkonija, stabiliziranega z itrijem (Y-TZP) (ISO 13356:2015)

Ta mednarodni standard določa zahteve 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
Published
Publication Date
29-Sep-2015
Withdrawal Date
30-Mar-2016
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 55 - Dentistry
Drafting Committee
CEN/TC 55 - Dentistry
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
30-Sep-2015
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 13356:2015 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)

Relations

Replaces
EN ISO 13356:2013 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2008)
Effective Date
08-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13356:2015
01-december-2015
1DGRPHãþD
SIST EN ISO 13356:2013
9VDGNL LPSODQWDWL ]DNLUXUJLMR.HUDPLþQLPDWHULDOLQDRVQRYLWHWUDJRQDOQHJD
FLUNRQLMDVWDELOL]LUDQHJD]LWULMHP <7=3  ,62
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
SIST EN ISO 13356:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13356:2015

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SIST EN ISO 13356:2015


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.

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SIST EN ISO 13356:2015
EN ISO 13356:2015 (E)
Contents Page
European foreword . 3
2

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SIST EN ISO 13356:2015
EN ISO 13356:2015 (E)
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.

3

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SIST EN ISO 13356:2015

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SIST EN ISO 13356:
...

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