BS ISO 12891-2:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
Hardcopy , PDF
01-05-2020
English
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Superseded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 |
ASTM D 2857 : 2016 | Standard Practice for Dilute Solution Viscosity of Polymers |
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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 |
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 |
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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 |
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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