EN ISO 13356:2015
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Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)
Published date
30-09-2015
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European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Physical and chemical properties
4 Test methods
Bibliography
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.
| Committee |
CEN/TC 55
|
| DevelopmentNote |
Supersedes PREN ISO 13356. (04/2013)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 13356 : 2013 | Identical |
| SN EN ISO 13356:2016 | Identical |
| I.S. EN ISO 13356:2015 | Identical |
| ISO 13356:2015 | Identical |
| SS-EN ISO 13356:2015 | Identical |
| NEN EN ISO 13356 : 2015 | Identical |
| NBN EN ISO 13356 : 2013 | Identical |
| NF EN ISO 13356 : 2015 | Identical |
| UNI EN ISO 13356 : 2015 | Identical |
| DIN EN ISO 13356:2016-02 | Identical |
| BS EN ISO 13356:2015 | Identical |
| NS EN ISO 13356 : 2015 | Identical |
| PN EN ISO 13356 : 2016 | Identical |
| UNE-EN ISO 13356:2015 | Identical |
| PNE-prEN ISO 13356 | Identical |
| EN 843-2:2006 | Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 2: Determination of Young's modulus, shear modulus and Poisson's ratio |
| ISO 20501:2003 | Fine ceramics (advanced ceramics, advanced technical ceramics) Weibull statistics for strength data |
| ISO 3310-1:2016 | Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth |
| EN 843-1:2006 | Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 1: Determination of flexural strength |
| ISO 18754:2013 | Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of density and apparent porosity |
| ISO 12677:2011 | Chemical analysis of refractory products by X-ray fluorescence (XRF) Fused cast-bead method |
| EN 843-5:2006 | Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 5: Statistical analysis |
| ASTM C 1327 : 2015 : REDLINE | TEST METHOD FOR VICKERS INDENTATION HARDNESS OF ADVANCED CERAMICS |
| ISO 22214:2006 | Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for cyclic bending fatigue of monolithic ceramics at room temperature |
| ASTM C 1259 : 2015 : REDLINE | Standard Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Impulse Excitation of Vibration |
| ISO 14705:2016 | Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for hardness of monolithic ceramics at room temperature |
| EN 623-2:1993 | Advanced technical ceramics - Monolithic ceramics - General and textural properties - Part 2: Determination of density and porosity |
| ISO 14704:2016 | Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for flexural strength of monolithic ceramics at room temperature |
| EN 843-4:2005 | Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 4: Vickers, Knoop and Rockwell superficial hardness |
| ASTM C 1499 : 2015 : REDLINE | TEST METHOD FOR MONOTONIC EQUIBIAXIAL FLEXURAL STRENGTH OF ADVANCED CERAMICS AT AMBIENT TEMPERATURE |
| ISO 3611:2010 | Geometrical product specifications (GPS) — Dimensional measuring equipment: Micrometers for external measurements — Design and metrological characteristics |
| ISO 17561:2016 | Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for elastic moduli of monolithic ceramics at room temperature by sonic resonance |
| ISO 7500-1:2015 | Metallic materials Calibration and verification of static uniaxial testing machines Part 1: Tension/compression testing machines Calibration and verification of the force-measuring system |
| ISO 13383-1:2012 | Fine ceramics (advanced ceramics, advanced technical ceramics) — Microstructural characterization — Part 1: Determination of grain size and size distribution |
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