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ASTM F1672-95(2011)

(Specification)

Standard Specification for Resurfacing Patellar Prosthesis

Standard Specification for Resurfacing Patellar Prosthesis

ABSTRACT
This specification covers the basic material descriptions, device geometry (axisymmetric and nonsymmetric), and in-vivo performance characteristics of patellar resurfacing prosthetic devices used to provide a functioning articulation between the bones of the patella and the femur. This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001. All devices conforming to this specification shall be fabricated from materials with adequate mechanical strength and durability, corrosion resistance, and biocompatibility. In the evaluation of their safety and efficacy, patella prosthesis shall adhere to the minimum acceptance criteria specified for the following failure modes: dislocation or laterial subluxation; component disassociation; fixation failure; device fracture; and articular surface wear.
SCOPE
1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between the patella and the femur.
1.2 This specification is intended to provide basic descriptions of material and device geometry. Additionally, those characteristics determined to be important to in-vivo performance of the device are defined.  
1.3 This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001.
Note 1—Devices for custom applications are not covered by this specification.

General Information

Status
Historical
Publication Date
28-Feb-2011
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 F1672-95(2005) - Standard Specification for Resurfacing Patellar Prosthesis
Effective Date
01-Mar-2011
Replaced By
ASTM F1672-14 - Standard Specification for Resurfacing Patellar Prosthesis
Effective Date
01-Apr-2014
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Mar-2011

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ASTM F1672-95(2011) - Standard Specification for Resurfacing Patellar ProsthesisASTM F1672-95(2011) - Standard Specification for Resurfacing Patellar Prosthesis
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ASTM F1672-95(2011) - Standard Specification for Resurfacing Patellar Prosthesis
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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:F1672 −95(Reapproved 2011)
Standard Specification for
1
Resurfacing Patellar Prosthesis
This standard is issued under the fixed designation F1672; 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 Applications (UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-
1.1 This specification covers patellar resurfacing devices
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
used to provide a functioning articulation between the patella
for Surgical Implant Applications (UNS R30563) (With-
and the femur.
3
drawn 2005)
1.2 This specification is intended to provide basic descrip-
F603 Specification for High-Purity Dense Aluminum Oxide
tions of material and device geometry. Additionally, those
for Medical Application
characteristics determined to be important to in-vivo perfor-
F648 Specification for Ultra-High-Molecular-Weight Poly-
mance of the device are defined.
ethylene Powder and Fabricated Form for Surgical Im-
1.3 This specification does not cover the details for quality
plants
assurance, design control, and production control contained in
F732 Test Method for Wear Testing of Polymeric Materials
21 CFR 820 and ISO 9001.
Used in Total Joint Prostheses
NOTE 1—Devices for custom applications are not covered by this F745 Specification for 18Chromium-12.5Nickel-
specification.
2.5Molybdenum Stainless Steel for Cast and Solution-
Annealed Surgical Implant Applications (Withdrawn
2. Referenced Documents
3
2012)
2
2.1 ASTM Standards:
F746 Test Method for Pitting or Crevice Corrosion of
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
Metallic Surgical Implant Materials
Alloy Castings and Casting Alloy for Surgical Implants
F748 PracticeforSelectingGenericBiologicalTestMethods
(UNS R30075)
for Materials and Devices
F86 Practice for Surface Preparation and Marking of Metal-
F799 Specification for Cobalt-28Chromium-6Molybdenum
lic Surgical Implants
Alloy Forgings for Surgical Implants (UNS R31537,
F90 Specification for Wrought Cobalt-20Chromium-
R31538, R31539)
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
F981 Practice for Assessment of Compatibility of Biomate-
tions (UNS R30605)
rials for Surgical Implants with Respect to Effect of
F136 Specification for Wrought Titanium-6Aluminum-
Materials on Muscle and Bone
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
F983 Practice for Permanent Marking of Orthopaedic Im-
Implant Applications (UNS R56401)
plant Components
F138 Specification for Wrought 18Chromium-14Nickel-
F1044 Test Method for Shear Testing of Calcium Phosphate
2.5Molybdenum Stainless Steel Bar andWire for Surgical
Coatings and Metallic Coatings
Implants (UNS S31673)
F1108 Specification for Titanium-6Aluminum-4Vanadium
F451 Specification for Acrylic Bone Cement
Alloy Castings for Surgical Implants (UNS R56406)
F562 Specification for Wrought 35Cobalt-35Nickel-
F1147 Test Method for Tension Testing of Calcium Phos-
20Chromium-10Molybdenum Alloy for Surgical Implant
phate and Metallic Coatings
2.2 Government Document:
1
This specification is under the jurisdiction of ASTM Committee F04 on
21 CFR 820 Good Manufacturing Practice for Medical
Medical and Surgical Materials and Devices and is under the direct responsibility of
4
Devices
Subcommittee F04.22 on Arthroplasty.
Current edition approved March 1, 2011. Published April 2011. Originally
approved in 1995. Last previous edition approved in 2005 as F1672 – 95 (2005).
DOI: 10.1520/F1672-95R11.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.astm.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from Superintendent of Documents, U.S. Government Printing
the ASTM website. Office, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1672−95 (2011)
2.3 ISO Standard: 3.1.5 W —maximummedial-lateralwidthofthearticulating
1
ISO 9001 Quality Systems Model for Quality Assurance in surface in the frontal plane.
Design/Development, Production, Installation, and Ser-
3.1.6 W —maximum medial-lateral width of the metal back
2
5
vicing
in the frontal plane.
3.1.7 H —articulating surface superior-inferior height in the
3. Terminology 1
frontal plane.
3.1 Definitions—Dimensions defined as follows are mea-
3.1.8 H —metal back superior-inferior height in the frontal
2
sured in whole o
...

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SCOPE
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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.
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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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1.6 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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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