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ASTM F 2068 : 2015 : REDLINE

Current

Current

The latest, up-to-date edition.

Standard Specification for Femoral Prostheses—Metallic Implants

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English

Published date

15-03-2015

€67.30
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CONTAINED IN VOL. 13.01, 2015 Describes metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-prostheses or total hip surgical procedures.

Committee
F 04
DocumentType
Redline
Pages
8
PublisherName
American Society for Testing and Materials
Status
Current

1.1This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads.

1.2Modular femoral heads, which may be affixed to cones on implants covered by this specification, are not covered by this specification. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integral implants are covered by this specification.

1.3Femoral prostheses included within the scope of this specification are intended for fixation by press fit between the prosthesis and host bone, the use of bone cement, or through the ingrowth of host bone into a porous coating.

1.4Custom femoral prostheses, designed explicitly for a single patient, are not covered within the scope of this specification.

1.5Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, or porous-polymer coatings, are specifically excluded from the scope of this specification.

1.6The requirements for modular connections of multicomponent modular femoral hip prostheses are not covered by this specification.

1.7The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ASTM F 3018 : 2017 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
ISO 7206-6:2013 Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
BS ISO 7206-6:2013 Implants for surgery. Partial and total hip joint prostheses Endurance properties testing and performance requirements of neck region of stemmed femoral components

ASTM F 86 : 2013 : REDLINE Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
ISO 5832-1:2016 Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
ISO 7206-8:1995 Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion
ASTM F 1472 : 2014 : REDLINE Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
ASTM F 90 : 2014 : REDLINE Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
ISO 5832-3:2016 Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 7206-4:2010 Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components
ASTM F 136 : 2013 : REDLINE Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
ASTM F 1813 : 2013 : REDLINE Standard Specification for Wrought Titanium<span class='unicode'>–</span>12 Molybdenum<span class='unicode'>–</span>6 Zirconium<span class='unicode'>–</span>2 Iron Alloy for Surgical Implant (UNS R58120)
ISO 7206-6:2013 Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
ASTM F 1108 : 2014 : REDLINE Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
ISO 5832-4:2014 Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
ASTM F 1586 : 2013 : EDT 1 Standard Specification for Wrought Nitrogen Strengthened 21Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
ISO 5832-14:2007 Implants for surgery Metallic materials Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
ASTM F 2996 : 2013 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 1537 : 2011 : REDLINE Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
ASTM F 1814 : 2015 : REDLINE Standard Guide for Evaluating Modular Hip and Knee Joint Components
ISO 7206-2:2011 Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
ASTM F 799 : 2011 : REDLINE SPECIFICATION FOR COBALT-28CHROMIUM-6MOLYBDENUM ALLOY FORGINGS FOR SURGICAL IMPLANTS (UNS R31537, R31538, R31539)
ISO 5832-12:2007 Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy
ASTM F 562 : 2013 : REDLINE Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
ISO 5832-9:2007 Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel
ASTM F 1854 : 2015 : REDLINE Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
ISO 7206-7:1993 Implants for surgery — Partial and total hip joint prostheses — Part 7: Endurance performance of stemmed femoral components without application of torsion

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