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ASTM F2068-00

(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

Replaced By
ASTM F2068-01 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
10-Jul-2001
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 F2068-00 - Standard Specification for Femoral Prostheses—Metallic ImplantsASTM F2068-00 - Standard Specification for Femoral Prostheses—Metallic Implants
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ASTM F2068-00 - 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 discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2068 – 00
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.
2
1. Scope Tungsten-Nickel Alloy for Surgical Implant Applications
F 136 Specification for Wrought Titanium-6 Aluminum-4
1.1 This specification covers metallic stemmed femoral
Vanadium ELI (Extra-Low Interstitial) Alloy (R56401) for
prostheses used to replace the natural hop joint by means of
2
Surgical Implant Applications
hemi-arthroplasty or total hip surgical procedures. Prostheses
F 138 Specification for Wrought 18 Chromium-14 Nickel-
for hemi-arthroplasty are intended to articulate with the natural
2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
acetabulum of the patient. Prostheses for total hip replacement
2
Implants (UNS S31673)
are intended to articulate with prosthetic acetabular cups.
F 562 Specification for Wrought Cobalt-35 Nickel-20
Prostheses may have integral femoral heads or cones designed
Chromium-10 Molybdenum Alloy for Surgical Implant
to accept modular heads.
2
Applications
1.2 Modular femoral heads, which may be affixed to cones
F 563 Specification for Wrought Cobalt-Nickel-Chromium-
on implants covered by this specification, are not covered by
Molybdenum-Tungsten-Iron Alloy for Surgical Implant
this specification. The mechanical strength, corrosion resis-
2
Applications
tance, and biocompatibility of the head portions of one-piece
F 620 Specification for Titanium 6Al-4V ELI Alloy Forg-
integral implants are covered by this specification.
2
ings for Surgical Implants
1.3 Femoral prostheses included within the scope of this
F 745 Specification for 18 Chromium-12.5 Nickel-2.5 Mo-
specification are intended for fixation by press fit between the
lybdenum Stainless Steel for Cast and Solution-Annealed
prosthesis and host bone, the use of bone cement, or through
2
Surgical Implant Applications
the ingrowth of host bone into a porous coating.
F 746 Test Method for Pitting or Crevice Corrosion of
1.4 Custom femoral prostheses, designed explicitly for a
2
Metallic Surgical Implant Materials
single patient, are not covered within the scope of this
F 748 Practice for Selecting Generic Biological Test Meth-
specification.
2
ods for Materials and Devices
1.5 Prostheses incorporating nonmetallic (for example,
F 799 Specification for Cobalt-28 Chromium-6 Molybde-
polymer composite) implants, nonporous bioactive ceramic
2
num Alloy Forgings for Surgical Implants
coatings, or porous-polymer coatings, are specifically excluded
F 981 Practice for Assessment of Compatibility of Bioma-
from the scope of this specification.
terials for Surgical Implants with Respect to Effect of
1.6 The requirements for modular connections of multicom-
2
Materials on Muscle and Bone
ponent modular femoral hip prostheses are not covered by this
F 983 Practice for Permanent Marking of Orthopedic Im-
specification.
2
plant Components
1.7 The values stated in SI units are to be regarded as the
F 1044 Test Method for Shear Testing of Porous Metal
standard.
2
Coatings
2. Referenced Documents
F 1108 Specification for TI6Al4V Alloy Castings for Sur-
2
gical Implants
2.1 ASTM Standards:
F 1147 Test Method for Tension Testing of Porous Metal
F 67 Specification for Unalloyed Titanium for Surgical
2
2
Coatings
Implant Applications
F 1440 Practice for Cyclic Fatigue Testing of Metallic
F 75 Specification for Cast Cobalt—Chromium-
2
Stemmed Hip Arthroplasty Femoral Components Without
Molybdenum Alloy for Surgical Implant Applications
2
Torsion
F 86 Practice for Surface Preparation and Marking of Me-
2
F 1472 Specification for Wrought Ti-6Al-4V Alloy for Sur-
tallic Surgical Implants
2
gical Implant Applications
F 90 Specification for Wrought Cobalt-Chromium-
F 1537 Specification for Wrought Cobalt-28 Chromium-6
2
Molybdenum Alloy for Surgical Implants
1
This specification is under the jurisdiction of ASTM Committee F04 on
F 1580 Specification for Titanium and Titanium-6 %
Medical and Surgical Materials and Devices and is the direct responsibility of
Aluminum-4 % Vanadium Alloy Powders for Coatings of
Subcommittee F04.22 on Arthroplasty.
2
Current edition approved Nov. 10, 2000. Published January 2001.
Surgical Implants
2
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 2068
F 1612 Practice for Cyclic Fatigue Testing of Metallic 3.1.7 modular (Type II) head, n—a femoral head that is not
Stemmed Hip Arthro
...

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4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.
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SCOPE
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.  
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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.
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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.  
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1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
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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.  
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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.  
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Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
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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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
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.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.

  • Guide
    8 pages
    English language
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  • Guide
    8 pages
    English language
    sale 15% off