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BS ISO 12891-2:2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Retrieval and analysis of surgical implants Analysis of retrieved surgical implants

Available format(s)

Hardcopy , PDF

Superseded date

01-05-2020

Language(s)

English

Published date

30-09-2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedures for retrieval, handling and packaging
5 Analysis of the implant interfaces
6 Analysis of the implant
7 Implant performance
Annex A (normative) - Standard forms for the
        analysis of retrieved surgical implants
Annex B (informative) - ISO Standards applicable
        for the evaluation of materials
Bibliography

Describes methods for the analysis of retrieved surgical implants.

Committee
CH/150
DevelopmentNote
Supersedes 13/30242622 DC. (09/2014)
DocumentType
Standard
Pages
40
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 12891-2:2014 Identical

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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
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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
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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
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
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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
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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
ASTM D 3 : 2018 Method of Test for Toughness of Rock (Withdrawn 1964)
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
ISO 6892-2:2011 Metallic materials Tensile testing Part 2: Method of test at elevated temperature
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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