• ISO 12891-2:2014

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants

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

    Withdrawn date:  16-07-2021

    Language(s):  English

    Published date:  08-09-2014

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 12891-2:2014 specifies methods for the analysis of retrieved surgical implants.

    ISO 12891-2:2014 describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive.

    ISO 12891-2:2014 can also be applied to other materials, e.g. animal tissue implants.

    ISO 12891-2:2014 can be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material.

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

    Development Note Supersedes ISO/DIS 12891-2. Supersedes and incorporates ISO 12891-3 and ISO 2891-4. (09/2014)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    ASTM F 3037 : 2015 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)

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

    ASTM D 2857 : 2016 Standard Practice for Dilute Solution Viscosity of Polymers
    ISO 6507-1:2005 Metallic materials Vickers hardness test Part 1: Test method
    ISO 5017:2013 Dense shaped refractory products — Determination of bulk density, apparent porosity and true porosity
    ASTM D 3418 : 2015 : REDLINE Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ISO 22088-1:2006 Plastics Determination of resistance to environmental stress cracking (ESC) Part 1: General guidance
    ISO 5832-1:2016 Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
    ASTM D 4001 : 2013 : REDLINE Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering
    ISO 3451-1:2008 Plastics Determination of ash Part 1: General methods
    ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
    ISO 4967:2013 Steel — Determination of content of non-metallic inclusions — Micrographic method using standard diagrams
    ISO 5832-11:2014 Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
    ISO 20160:2006 Implants for surgery Metallic materials Classification of microstructures for alpha+beta titanium alloy bars
    ASTM D 732 : 2017 : REDLINE Standard Test Method for Shear Strength of Plastics by Punch Tool
    ISO 458-1:1985 Plastics Determination of stiffness in torsion of flexible materials Part 1: General method
    ISO 5832-6:1997 Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
    ISO 22088-2:2006 Plastics Determination of resistance to environmental stress cracking (ESC) Part 2: Constant tensile load method
    ISO 14949:2001 Implants for surgery — Two-part addition-cure silicone elastomers
    ISO 13779-1:2008 Implants for surgery Hydroxyapatite Part 1: Ceramic hydroxyapatite
    ISO 5832-5:2005 Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
    ISO 6508-1:2016 Metallic materials — Rockwell hardness test — Part 1: Test method
    ISO 16402:2008 Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics
    ISO 6892:1998 Metallic materials Tensile testing at ambient temperature
    ASTM D 1623 : 2017 : REDLINE Standard Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
    ASTM D 5227 : 2013 : REDLINE Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins
    ISO 6892-1:2016 Metallic materials Tensile testing Part 1: Method of test at room temperature
    ISO 5832-3:2016 Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
    ISO 22088-5:2006 Plastics Determination of resistance to environmental stress cracking (ESC) Part 5: Constant tensile deformation method
    ASTM D 1004 : 2013 : REDLINE Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting
    ISO 4545-1:2005 Metallic materials Knoop hardness test Part 1: Test method
    ISO 13779-3:2008 Implants for surgery Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity
    ISO 15374:1998 Implants for surgery — Requirements for production of forgings
    ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
    ISO 60:1977 Plastics — Determination of apparent density of material that can be poured from a specified funnel
    ASTM D 1239 : 2014 : REDLINE Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
    ISO 4545:1993 Metallic materials Hardness test Knoop test
    ISO 5832-8:1997 Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
    ISO 13356:2015 Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
    ISO 13779-2:2008 Implants for surgery Hydroxyapatite Part 2: Coatings of hydroxyapatite
    ISO 7438:2016 Metallic materials Bend test
    ISO 5833:2002 Implants for surgery — Acrylic resin cements
    ISO 5832-4:2014 Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
    ASTM E 204 : 1998 Standard Practices for Identification of Material by Infrared Absorption Spectroscopy, Using the ASTM Coded Band and Chemical Classification Index
    ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
    ASTM E 353 : 2014 : REDLINE Standard Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys
    ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
    ISO 22088-3:2006 Plastics Determination of resistance to environmental stress cracking (ESC) Part 3: Bent strip method
    ISO 899-2:2003 Plastics Determination of creep behaviour Part 2: Flexural creep by three-point loading
    ISO 5834-2:2011 Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms
    ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
    ISO 5832-14:2007 Implants for surgery Metallic materials Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
    ISO 61:1976 Plastics — Determination of apparent density of moulding material that cannot be poured from a specified funnel
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    ISO 1183-1:2012 Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liquid pyknometer method and titration method
    ISO 1183-2:2004 Plastics Methods for determining the density of non-cellular plastics Part 2: Density gradient column method
    ISO 1183-3:1999 Plastics Methods for determining the density of non-cellular plastics Part 3: Gas pyknometer method
    ISO 604:2002 Plastics — Determination of compressive properties
    ISO 5832-2:1999 Implants for surgery Metallic materials Part 2: Unalloyed titanium
    ISO 179-1:2010 Plastics — Determination of Charpy impact properties — Part 1: Non-instrumented impact test
    ISO 15814:1999 Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing
    ISO 643:2012 Steels Micrographic determination of the apparent grain size
    ISO 62:2008 Plastics Determination of water absorption
    ISO 5832-7:2016 Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
    ISO 22088-4:2006 Plastics Determination of resistance to environmental stress cracking (ESC) Part 4: Ball or pin impression method
    ISO 15309:2013 Implants for surgery — Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
    ISO 22088-6:2006 Plastics Determination of resistance to environmental stress cracking (ESC) Part 6: Slow strain rate method
    ASTM D 1621 : 2016 : REDLINE Standard Test Method for Compressive Properties of Rigid Cellular Plastics
    ISO 899-1:2017 Plastics — Determination of creep behaviour — Part 1: Tensile creep
    ISO 9385:1990 Glass and glass-ceramics Knoop hardness test
    ASTM D 695 : 2015 : REDLINE Standard Test Method for Compressive Properties of Rigid Plastics
    ISO 13782:1996 Implants for surgery Metallic materials Unalloyed tantalum for surgical implant applications
    ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
    ISO 6721-1:2011 Plastics Determination of dynamic mechanical properties Part 1: General principles
    ISO 178:2010 Plastics Determination of flexural properties
    ASTM D 2990 : 2017 : REDLINE Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
    ISO 5832-12:2007 Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1: Retrieval and handling
    ASTM E 354 : 2014 : REDLINE Standard Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and Cobalt Alloys
    ISO 6474-2:2012 Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
    ISO 5832-9:2007 Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel
    ISO 527-1:2012 Plastics Determination of tensile properties Part 1: General principles
    ASTM D 4000 : 2016 : REDLINE Standard Classification System for Specifying Plastic Materials
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