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ASTM F2068-01e1

(Specification)

Standard Specification for Femoral Prostheses—Metallic Implants

Standard Specification for Femoral Prostheses—Metallic Implants

SCOPE
1.1 This 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.
1.2 Modular 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.
1.3 Femoral 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.
1.4 Custom femoral prostheses, designed explicitly for a single patient, are not covered within the scope of this specification.
1.5 Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, or porous-polymer coatings, are specifically excluded from the scope of this specification.
1.6 The requirements for modular connections of multicomponent modular femoral hip prostheses are not covered by this specification.
1.7 The values stated in SI units are to be regarded as the standard.

General Information

Status
Historical
Publication Date
09-Jul-2001
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Replaces
ASTM F2068-01 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
10-Jul-2001
Replaced By
ASTM F2068-03 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
10-Sep-2003
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
10-Jul-2001
Referred By
ASTM G195-22 - Standard Guide for Conducting Wear Tests Using a Rotary Platform Abraser
Effective Date
10-Jul-2001

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ASTM F2068-01e1 - Standard Specification for Femoral Prostheses—Metallic ImplantsASTM F2068-01e1 - Standard Specification for Femoral Prostheses—Metallic Implants
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ASTM F2068-01e1 - Standard Specification for Femoral Prostheses—Metallic Implants
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NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 2068 – 01
Standard Specification for
1
Femoral Prostheses—Metallic Implants
This standard is issued under the fixed designation F 2068; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Note 2 was editorially corrected in May 2003.
1. Scope F 75 Specification for Cobalt-28 Chromium-6 Molybdenum
2
Casting Alloy and Cast Products for Surgical Implants
1.1 This specification covers metallic stemmed femoral
F 86 Practice for Surface Preparation and Marking of Me-
prostheses used to replace the natural hip joint by means of
2
tallic Surgical Implants
hemi-arthroplasty or total hip surgical procedures. Prostheses
F 90 Specification for Wrought Cobalt-20 Chromium-15
for hemi-arthroplasty are intended to articulate with the natural
Tungsten-10 Nickel Alloy for Surgical Implant Applica-
acetabulum of the patient. Prostheses for total hip replacement
2
tions (UNS R30605)
are intended to articulate with prosthetic acetabular cups.
F 136 Specification for Wrought Titanium-6 Aluminum-4
Prostheses may have integral femoral heads or cones designed
Vanadium ELI (Extra-Low Interstitial) Alloy (R56401) for
to accept modular heads.
2
Surgical Implant Applications
1.2 Modular femoral heads, which may be affixed to cones
F 138 Specification for Wrought 18 Chromium-14 Nickel-
on implants covered by this specification, are not covered by
2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
this specification. The mechanical strength, corrosion resis-
2
Implants (UNS S31673)
tance, and biocompatibility of the head portions of one-piece
F 562 Specification for Wrought Cobalt-35 Nickel-20
integral implants are covered by this specification.
Chromium-10 Molybdenum Alloy for Surgical Implant
1.3 Femoral prostheses included within the scope of this
2
Applications UNS R 30035
specification are intended for fixation by press fit between the
F 563 Specification for Wrought Cobalt-20Nickel-
prosthesis and host bone, the use of bone cement, or through
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
the ingrowth of host bone into a porous coating.
2
for Surgical Implant Applications (UNS R30563)
1.4 Custom femoral prostheses, designed explicitly for a
F 620 Specification for Alpha Plus Beta Titanium Alloy
single patient, are not covered within the scope of this
2
Forgings for Surgical Implants
specification.
F 745 Specification for 18Chromium-12.5Nickel-
1.5 Prostheses incorporating nonmetallic (for example,
2.5Molybdenum Stainless Steel for Cast and Solution-
polymer composite) implants, nonporous bioactive ceramic
2
Annealed Surgical Implant Applications
coatings, or porous-polymer coatings, are specifically excluded
F 746 Test Method for Pitting or Crevice Corrosion of
from the scope of this specification.
2
Metallic Surgical Implant Materials
1.6 The requirements for modular connections of multicom-
F 748 Practice for Selecting Generic Biological Test Meth-
ponent modular femoral hip prostheses are not covered by this
2
ods for Materials and Devices
specification.
F 799 Specification for Cobalt-28Chromium-6Molybdenum
1.7 The values stated in SI units are to be regarded as the
Alloy Forgings for Surgical Implants (UNS R31537,
standard.
2
R31538, R31539)
2. Referenced Documents F 981 Practice for Assessment of Compatibility of Bioma-
terials for Surgical Implants with Respect to Effect of
2.1 ASTM Standards:
2
Materials on Muscle and Bone
F 67 Specification for Unalloyed Titanium for Surgical
2
F 983 Practice for Permanent Marking of Orthopaedic Im-
Implant Applications
2
plant Components
F 1044 Test Method for Shear Testing of Calcium Phos-
1 2
This specification is under the jurisdiction of ASTM Committee F04 on
phate Coatings and Metallic Coatings
Medical and Surgical Materials and Devices and is the direct responsibility of
F 1108 Specification for Titanium—6 Aluminum-4 Vana-
Subcommittee F04.22 on Arthroplasty.
2
dium Alloy Castings for Surgical Implants (UNS R56406)
Current edition approved July 10, 2001. Published October 2001. Originally
published as F 2068 - 00. Last previous edition F 2068 - 00.
2
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
F2068–01
F 1147 Test Method for Tension Testing of Calcium Phos- 3.1.2 collar, n—flange at the junction of the neck and
2
phate and
...

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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A1.1 Significance and Use
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1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off