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

Standard No.

ISO 13356:2015

Release Date

2015

Published By

International Organization for Standardization (ISO)

Latest

ISO 13356:2015

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.

ISO 13356:2015 Referenced Document

• ASTM C1161-13 Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature*， 2024-04-20 Update
• ASTM C1198-09 Standard Test Method for Dynamic Young''s Modulus, Shear Modulus, and Poisson''s Ratio for Advanced Ceramics by Sonic Resonance*， 2024-04-20 Update
• ASTM C1239-13 Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics*， 2024-04-20 Update
• ASTM C1259-15 Standard Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Impulse Excitation of Vibration*， 2024-04-20 Update
• ASTM C1327-15 Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics*， 2024-04-20 Update
• ASTM C1331-01 Standard Test Method for Measuring Ultrasonic Velocity in Advanced Ceramics with Broadband Pulse-Echo Cross-Correlation Method*， 2024-04-20 Update
• ASTM C1499-09 Standard Test Method for Monotonic Equibiaxial Flexural Strength of Advanced Ceramics at Ambient Temperature*， 2024-04-20 Update
• ASTM E112-13 Standard Test Methods for Determining Average Grain Size*， 2024-04-20 Update
• EN 623-2:1993 Advanced technical ceramics; monolithic ceramics; general and textural properties; part 2: determination of density and porosity
• EN 843-1:2006 Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 1: Determination of flexural strength*， 2024-04-20 Update
• 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*， 2024-04-20 Update
• EN 843-4:2005 Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 4: Vickers, Knoop and Rockwell superficial hardness
• EN 843-5:2006 Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 5: Statistical analysis*， 2024-04-20 Update
• ISO ISO IEC 27001-2013 cor2-2015 technical errata*， 2024-04-20 Update
• ISO 3310-1:2000 Test sieves - Technical requirements and testing - Part 1: Test sieves of metal wire cloth
• ISO 3611:2010 Geometrical product specifications (GPS) - Dimensional measuring equipment: Micrometers for external measurements - Design and metrological characteristics
• 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 13356:2015 history

• 2015 ISO 13356:2015 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
• 2008 ISO 13356:2008 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
• 1997 ISO 13356:1997 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)