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  • ISO 6474-1:2010

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  15-03-2019

    Language(s):  English, French, Russian

    Published date:  28-01-2010

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 6474-1:2010 specifies the characteristics of, and corresponding test methods for, a bio-compatible and bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO 6474. (02/2012) DRAFT ISO/DIS 6474-1 is also available for this standard. (04/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN ISO 10555-6:2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
    DIN EN ISO 10555-6:2017-11 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
    13/30261812 DC : 0 BS ISO 10555-6 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
    BS ISO 6474-2:2012 Implants for surgery. Ceramic materials Composite materials based on a high-purity alumina matrix with zirconia reinforcement
    DIN EN ISO 10555-6 E : 2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
    BS ISO 12891-2:2014 Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
    ANSI/AAMI/ISO 16142-1:2016 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    BS EN ISO 10993-6:2016 Biological evaluation of medical devices Tests for local effects after implantation
    I.S. EN ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
    I.S. EN ISO 10451:2010 DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
    BS ISO 10555-6 : 2015 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
    EN ISO 10555-6:2017 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
    10/30196848 DC : 0 BS ISO 6474-2 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 2: COMPOSITE MATERIALS BASED ON A HIGH PURITY ALUMINA MATRIX WITH ZIRCONIA REINFORCEMENT
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    ANSI/AAMI/ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    ASTM F 3018 : 2017 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
    BS EN ISO 10555-6:2017 Intravascular catheters. Sterile and single-use catheters Subcutaneous implanted ports
    ISO 6474-2:2012 Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
    ISO 10555-6:2015 Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports
    UNI EN ISO 10451 : 2010 DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
    17/30361518 DC : 0 BS ISO 6474-2 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 2: COMPOSITE MATERIALS BASED ON A HIGH-PURITY ALUMINA MATRIX WITH ZIRCONIA REINFORCEMENT
    14/30261590 DC : 0 BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
    13/30242622 DC : 0 BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS
    ISO 12891-2:2014 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants
    BS EN ISO 10451:2010 Dentistry. Contents of technical file for dental implant systems
    ISO 10451:2010 Dentistry — Contents of technical file for dental implant systems
    EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    EN ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
    ASTM F 2091 : 2015 : REDLINE Standard Specification for Acetabular Prostheses
    ASTM F 2083 : 2012 : REDLINE Standard Specification for Knee Replacement Prosthesis
    DIN EN ISO 10451:2010-11 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
    DIN EN ISO 10993-6:2009-08 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    DIN EN ISO 10993-6:2017-09 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 23146:2012 Fine ceramics (advanced ceramics, advanced technical ceramics) — Test methods for fracture toughness of monolithic ceramics — Single-edge V-notch beam (SEVNB) method
    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
    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 14242-1:2014 Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
    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 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 13356:2015 Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
    EN 725-1:2007 Advanced technical ceramics - Methods of test for ceramic powders - Part 1: Determination of impurities in alumina
    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
    ISO 18756:2003 Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of fracture toughness of monolithic ceramics at room temperature by the surface crack in flexure (SCF) method
    CEN/TS 14425-5 : 2004 ADVANCED TECHNICAL CERAMICS - TEST METHODS FOR DETERMINATION OF FRACTURE TOUGHNESS OF MONOLITIC CERAMICS - PART 5: SINGLE-EDGE VEE-NOTCH BEAM (SEVNB) METHOD
    EN 843-4 : 2005 ADVANCED TECHNICAL CERAMICS - MECHANICAL PROPERTIES OF MONOLITHIC CERAMICS AT ROOM TEMPERATURE - PART 4: VICKERS, KNOOP AND ROCKWELL SUPERFICIAL HARDNESS
    EN 623-3 : 2001 ADVANCED TECHNICAL CERAMICS - MONOLITHIC CERAMICS - GENERAL AND TEXTURAL PROPERTIES - DETERMINATION OF GRAIN SIZE AND SIZE DISTRIBUTION (CHARACTERIZED BY THE LINEAR INTERCEPT METHOD)
    ASTM C 1499 : 2015 : REDLINE TEST METHOD FOR MONOTONIC EQUIBIAXIAL FLEXURAL STRENGTH OF ADVANCED CERAMICS AT AMBIENT TEMPERATURE
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    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 15732:2003 Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for fracture toughness of monolithic ceramics at room temperature by single edge precracked beam (SEPB) method
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