BS EN ISO 13356:2015

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Implants for surgery. Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)

Published By	Publication Date	Number of Pages
BSI	2015	24

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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Description

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.

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PDF Pages	PDF Title
4	European foreword Endorsement notice
6	Foreword
7	Introduction
9	1 Scope 2 Normative references
10	3 Physical and chemical properties 3.1 Test category 3.1.1 General 3.1.2 Category 1 3.1.3 Category 2
12	4 Test methods 4.1 General 4.2 Bulk density 4.3 Chemical composition 4.4 Microstructure 4.4.1 Principle
13	4.4.2 Test report 4.4.3 Amount of monoclinic phase
14	4.5 Biaxial flexural strength 4.5.1 Principle 4.5.2 Apparatus 4.5.3 Preparation of test specimens
15	4.5.4 Procedure
16	4.5.5 Calculation of results 4.5.6 Test report 4.6 Four-point bending strength
17	4.7 Weibull modulus 4.8 Young’s modulus 4.9 Hardness 4.10 Cyclic fatigue 4.10.1 Principle 4.10.2 Apparatus 4.10.3 Sample size and preparation of test specimens 4.10.4 Procedure and sample requirement
18	4.10.5 Test Report 4.11 Radioactivity 4.11.1 Principle 4.11.2 Apparatus
19	4.11.3 Sample preparation 4.11.4 Isotope identification – Energy calibration 4.11.5 Quantitative analysis
20	4.11.6 Expression of results 4.11.7 Test report 4.12 Accelerated aging test 4.12.1 General 4.12.2 Procedure 4.12.3 Evaluation of accelerated aging outcome
21	Bibliography

Additional information

Status	Confirmed
Pages	24
Publication Date	2015-10-31
ISBN	978 0 580 81541 6
Standard Number	BS EN ISO 13356:2015
Title	Implants for surgery. Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
Identical National Standard Of	EN ISO 13356:2015, ISO 13356:2015
Replaces	BS EN ISO 13356:2013
Descriptors	Physical properties of materials, Implants (surgical), Zirconium inorganic compounds, Bend testing, Radiation measurement, Surgical equipment, Specimen preparation, Radioactivity, Fatigue testing, Chemical composition, Crystal microstructure, Testing conditions, Ceramics, Yttrium inorganic compounds, Oxides
Publisher	BSI
Committee	CH/150/1
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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BS EN ISO 13356:2015

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