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ASTM F2091-01(2006)

(Specification)

Standard Specification for Acetabular Prostheses

Standard Specification for Acetabular Prostheses

ABSTRACT
This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. Acetabular prostheses included within the scope of this specification are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement or through biological fixation. Acetabular prostheses shall be classified as: Type I and Type II. The following test methods shall be performed: mechanical strength; corrosion resistance; biocompatibility; structural requirements; metal and ceramic coating or surface texture integrity; component disassociation; fixation failure; device fracture; and articular surface wear.
SCOPE
1.1 This standard describes acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur.
1.2 This standard is intended to provide basic descriptions of materials and device geometry. Additionally, those characteristics determined to be important to in vivo performance of the device are defined.
1.3 Acetabular prostheses included within the scope of this standard are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement or through biological fixation.
1.4 Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this standard.
1.5 This standard does not cover the details for quality assurance, design control, production control contained in 21 CFR 820 (Quality System Regulation) and ISO 9001.

General Information

Status
Historical
Publication Date
28-Feb-2006
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 F2091-01 - Standard Specification for Acetabular Prostheses
Effective Date
01-Mar-2006
Replaced By
ASTM F2091-01(2012) - Standard Specification for Acetabular Prostheses
Effective Date
15-Jan-2012
Referred By
ASTM F2582-20 - Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
Effective Date
01-Mar-2006
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
01-Mar-2006

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ASTM F2091-01(2006) - Standard Specification for Acetabular ProsthesesASTM F2091-01(2006) - Standard Specification for Acetabular Prostheses
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ASTM F2091-01(2006) - Standard Specification for Acetabular Prostheses
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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: F2091 – 01 (Reapproved 2006)
Standard Specification for
1
Acetabular Prostheses
This standard is issued under the fixed designation F2091; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope F138 Specification for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
1.1 This specification covers acetabular resurfacing devices
Implants (UNS S31673)
used to provide a functioning articulation between the bones of
F562 Specification for Wrought 35Cobalt-35Nickel-
the acetabulum and the femur.
20Chromium-10Molybdenum Alloy for Surgical Implant
1.2 This specification is intended to provide basic descrip-
Applications (UNS R30035)
tions of materials and device geometry. Additionally, those
F563 Specification for Wrought Cobalt-20Nickel-
characteristics determined to be important to in vivo perfor-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
mance of the device are defined.
3
for Surgical Implant Applications (UNS R30563)
1.3 Acetabular prostheses included within the scope of this
F601 Practice for Fluorescent Penetrant Inspection of Me-
specification are intended for mechanical fixation between the
tallic Surgical Implants
prosthesis and host bone, by the use of bone cement or through
F603 Specification for High-Purity DenseAluminum Oxide
biological fixation.
3
for Medical Application
1.4 Custom (designed explicitly for a single patient), revi-
F629 Practice for Radiography of Cast Metallic Surgical
sion, or constrained acetabular prostheses are not covered
Implants
within the scope of this specification.
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.5 This specification does not cover the details for quality
ethylene Powder and Fabricated Form for Surgical Im-
assurance, design control, production control contained in 21
plants
CFR 820 (Quality System Regulation) and ISO 9001.
F745 Specification for 18Chromium-12.5Nickel-
2. Referenced Documents 2.5Molybdenum Stainless Steel for Cast and Solution-
2
Annealed Surgical Implant Applications
2.1 ASTM Standards:
F746 Test Method for Pitting or Crevice Corrosion of
F67 Specification for Unalloyed Titanium, for Surgical
Metallic Surgical Implant Materials
Implant Applications (UNS R50250, UNS R50400, UNS
F748 Practice for Selecting Generic Biological Test Meth-
R50550, UNS R50700)
ods for Materials and Devices
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
F799 Specification for Cobalt-28Chromium-6Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
Alloy Forgings for Surgical Implants (UNS R31537,
(UNS R30075)
R31538, R31539)
F86 Practice for Surface Preparation and Marking of Me-
F981 Practice forAssessment of Compatibility of Biomate-
tallic Surgical Implants
rials for Surgical Implants with Respect to Effect of
F90 Specification for Wrought Cobalt-20Chromium-
Materials on Muscle and Bone
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
F983 Practice for Permanent Marking of Orthopaedic Im-
tions (UNS R30605)
plant Components
F136 Specification for Wrought Titanium-6Aluminum-
F1044 Test Method for ShearTesting of Calcium Phosphate
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
Coatings and Metallic Coatings
Implant Applications (UNS R56401)
F1108 Specification for Titanium-6Aluminum-4Vanadium
Alloy Castings for Surgical Implants (UNS R56406)
1
This specification is under the jurisdiction of ASTM Committee F04 on
F1147 Test Method for Tension Testing of Calcium Phos-
Medical and Surgical Materials and Devices and is the direct responsibility of
phate and Metallic Coatings
Subcommittee F04.22 on Arthroplasty.
F1160 Test Method for Shear and Bending Fatigue Testing
Current edition approved March 1, 2006. Published April 2006. Originally
of Calcium Phosphate and Metallic Medical and Compos-
approved in 2001. Last previous edition approved in 2001 as F2091 – 01. DOI:
10.1520/F2091-01R06.
ite Calcium Phosphate/Metallic Coatings
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
3
the ASTM website.
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2091 – 01 (2006)
F1185 SpecificationforCompositionofHydroxylapatitefor 3.1.4 flange, n—rim extending from the entry diameter of
Surgical Implants bearing element.
F1377 Specification for Cobalt-28Chromium- 3.1.5 porous coating, n—a r
...

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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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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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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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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

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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).  
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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