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ASTM F2068-03

(Specification)

Standard Specification for Femoral Prostheses—Metallic Implants

Standard Specification for Femoral Prostheses—Metallic Implants

ABSTRACT
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. Femoral prostheses presented are defined as follows: type IA - single-piece (mono-block), metallic femoral total hip or hemi-arthroplasty hip prosthesis with an integral stem, neck and head, type IB - single-piece (mono-block), metallic, femoral total hip or hemi- arthroplasty hip prostheses with an integral stem, neck, and head, type IIA - modular metallic femoral hip prostheses that could include a modular (type II) head or other modular components, or both, and type IIB - Modular metallic femoral hip prosthesis that could include a modular (type II) head or other modular components, or both. Femoral prostheses shall be capable of withstanding normal static and dynamic loading in the physiological range without overload fracture, plastic deformation, or fatigue fracture. Shear strength, tensile strength, and abrasion resistance of plasma spray thermal coatings shall be tested to meet the requirements prescribed.
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-Sep-2003
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 F2068-01e1 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
10-Sep-2003
Replaced By
ASTM F2068-09 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
01-Sep-2009
Referred By
ASTM G195-22 - Standard Guide for Conducting Wear Tests Using a Rotary Platform Abraser
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-Sep-2003

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ASTM F2068-03 - Standard Specification for Femoral Prostheses—Metallic ImplantsASTM F2068-03 - Standard Specification for Femoral Prostheses—Metallic Implants
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ASTM F2068-03 - Standard Specification for Femoral Prostheses—Metallic Implants
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2068 – 03
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. Scope F 75 Specification for Cobalt-28Chromium-6Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
1.1 This specification covers metallic stemmed femoral
2
(UNS R30075)
prostheses used to replace the natural hip joint by means of
F 86 Practice for Surface Preparation and Marking of Me-
hemi-arthroplasty or total hip surgical procedures. Prostheses
2
tallic Surgical Implants
for hemi-arthroplasty are intended to articulate with the natural
F 90 Specification for Wrought Cobalt-20Chromium-
acetabulum of the patient. Prostheses for total hip replacement
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
are intended to articulate with prosthetic acetabular cups.
2
tions (UNS R30605)
Prostheses may have integral femoral heads or cones designed
F 136 Specification for Wrought Titanium-6Aluminum-
to accept modular heads.
4Vanadium ELI (Extra-Low Interstitial)Alloy for Surgical
1.2 Modular femoral heads, which may be affixed to cones
2
Implant Applications (UNS R56401)
on implants covered by this specification, are not covered by
F 138 Specification for Wrought 18Chromium-14Nickel-
this specification. The mechanical strength, corrosion resis-
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
tance, and biocompatibility of the head portions of one-piece
2
Implants (UNS S31673)
integral implants are covered by this specification.
F 562 Specification for Wrought Cobalt-35Nickel-
1.3 Femoral prostheses included within the scope of this
20Chromium-10Molybdenum Alloy for Surgical Implant
specification are intended for fixation by press fit between the
2
Applications (UNS R 30035)
prosthesis and host bone, the use of bone cement, or through
F 563 Specification for Wrought Cobalt-20Nickel-
the ingrowth of host bone into a porous coating.
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
1.4 Custom femoral prostheses, designed explicitly for a
2
for Surgical Implant Applications (UNS R30563)
single patient, are not covered within the scope of this
F 620 Specification for Alpha Plus Beta Titanium Alloy
specification.
2
Forgings for Surgical Implants
1.5 Prostheses incorporating nonmetallic (for example,
F 745 Specification for 18Chromium-12.5Nickel-
polymer composite) implants, nonporous bioactive ceramic
2.5Molybdenum Stainless Steel for Cast and Solution-
coatings,orporous-polymercoatings,arespecificallyexcluded
2
Annealed Surgical Implant Applications
from the scope of this specification.
F 746 Test Method for Pitting or Crevice Corrosion of
1.6 The requirements for modular connections of multicom-
2
Metallic Surgical Implant Materials
ponent modular femoral hip prostheses are not covered by this
F 748 Practice for Selecting Generic Biological Test Meth-
specification.
2
ods for Materials and Devices
1.7 The values stated in SI units are to be regarded as the
F 799 SpecificationforCobalt-28Chromium-6Molybdenum
standard.
Alloy Forgings for Surgical Implants (UNS R31537,
2
2. Referenced Documents
R31538, R31539)
F 981 Practice for Assessment of Compatibility of Bioma-
2.1 ASTM Standards:
terials for Surgical Implants with Respect to Effect of
F 67 Specification for Unalloyed Titanium for Surgical
2
Materials on Muscle and Bone
Implant Applications (UNS R50250, UNS R 50400, UNS
2
F 983 Practice for Permanent Marking of Orthopaedic Im-
R 50550, UNS R50700)
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-6Aluminum-4Vanadium
Subcommittee F04.22 on Arthroplasty.
2
Alloy Castings for Surgical Implants (UNS R56406)
Current edition approved Sept. 10, 2003. Published October 2003. Originally
e1
approved in 2000. Last previous edition approved in 2001 as F 2068 – 01 .
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 ----------------------
F2068–03
F 1147 Test Method for Tension Testing of Calcium Phos- 3. Terminology
2
phate and Metallic Coatings
3.1 Definitions of Terms Specific to This Standard:
F 1440 Practice for Cyclic Fatigue Testing of Metallic
3.1.1 bore, n—an internal cavity, in the form of a truncated
Stemmed Hip Arthroplasty
...

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1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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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.
SCOPE
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.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
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ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
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
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off