ISO 6474-1:2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
15-03-2019
English, French, Russian
28-01-2010
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.
DevelopmentNote |
Supersedes ISO 6474. (02/2012) DRAFT ISO/DIS 6474-1 is also available for this standard. (04/2016)
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DocumentType |
Standard
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Pages |
9
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PublisherName |
International Organization for Standardization
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Status |
Withdrawn
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SupersededBy | |
Supersedes |
Standards | Relationship |
NF ISO 6474-1 : 2010 | Identical |
BS ISO 6474-1:2010 | Identical |
GOST R ISO 6474-1 : 2014 | Identical |
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 |
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) |
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 - Part 3: 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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