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ASTM F1672-95(2000)

(Specification)

Standard Specification for Resurfacing Patellar Prosthesis

Standard Specification for Resurfacing Patellar Prosthesis

SCOPE
1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between the bones of 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
31-Dec-1999
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 F1672-95e1 - Standard Specification for Resurfacing Patellar Prosthesis
Effective Date
01-Jan-2000
Replaced By
ASTM F1672-95(2005) - Standard Specification for Resurfacing Patellar Prosthesis
Effective Date
01-Oct-2005
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Jan-2000

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ASTM F1672-95(2000) - Standard Specification for Resurfacing Patellar ProsthesisASTM F1672-95(2000) - Standard Specification for Resurfacing Patellar Prosthesis
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ASTM F1672-95(2000) - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 1672 – 95 (Reapproved 2000)
Standard Specification for
1
Resurfacing Patellar Prosthesis
This standard is issued under the fixed designation F 1672; 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 Molybdenum-Tungsten-Iron Alloy for Surgical Implant
2
Applications
1.1 This specification covers patellar resurfacing devices
F 603 Specification for High-Purity Dense Aluminum Ox-
used to provide a functioning articulation between the bones of
2
ide for Surgical Implant Applications
the patella and the femur.
F 648 Specification for Ultra-High-Molecular-Weight Poly-
1.2 This specification is intended to provide basic descrip-
ethylene Powder and Fabricated Form for Surgical Im-
tions of material and device geometry. Additionally, those
3
plants
characteristics determined to be important to in-vivo perfor-
F 732 Practice for Reciprocating Pin-on-Flat Evaluation of
mance of the device are defined.
Friction and Wear Properties of Polymeric Materials for
1.3 This specification does not cover the details for quality
2
Use in Total Joint Prostheses
assurance, design control, and production control contained in
F 745 Specification for 18 Chromium-12.5 Nickel-2.5 Mo-
21 CFR 820 and ISO 9001.
lybdenumStainlessSteelforCastandSolution—Annealed
NOTE 1—Devices for custom applications are not covered by this 2
Surgical Implant Applications
specification.
F 746 Test Method for Pitting or Crevice Corrosion of
2
Metallic Surgical Implant Materials
2. Referenced Documents
F 748 Practice for Selecting Generic Biological Test Meth-
2.1 ASTM Standards:
2
ods for Materials and Devices
F75 SpecificationforCastCobalt-Chromium-Molybdenum
F 799 Specification for Cobalt-28 Chromium-6 Molybde-
2
Alloy for Surgical Implant Applications
2
num Alloy Forgings for Surgical Implants
F86 Practice for Surface Preparation and Marking of Me-
F 981 Practice for Assessment of Compatibility of Bioma-
2
tallic Surgical Implants
terials for Surgical Implants with Respect to Effect of
F90 Specification for Wrought Cobalt-Chromium-Nickel-
2
Materials on Muscle and Bone
2
Tungsten Alloy for Surgical Implant Applications
F 983 Practice for Permanent Marking of Orthopaedic Im-
F 136 Specification for Wrought Titanium 6Al-4V ELI
2
plant Components
2
Alloy for Surgical Implant Applications
F 1044 Test Method for Shear Testing of Porous Metal
F 138 Specification for Stainless Steel Bar and Wire for
2
Coatings
2
Surgical Implants (Special Quality)
F 1108 Specification for Ti6Al4VAlloy Castings for Surgi-
2
F 451 Specification for Acrylic Bone Cement
2
cal Implants
F 562 Specification for Wrought Cobalt-35 Nickel 20-
F 1147 Test Method for Tension Testing of Porous Metal
Chromium 10-Molybdenum Alloy for Surgical Implant
2
Coatings
2
Applications
2.2 Government Document:
F 563 Specification for Wrought Cobalt-Nickel-Chromium-
21 CFR 820-Good Manufacturing Practice for Medical
4
Devices
2.3 ISO Standard:
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is under the direct responsibility of
3
Subcommittee F04.22 on Arthroplasty. Discontinued; see 1994 Annual Book of ASTM Standards, Vol 13.01.
4
Current edition approved Nov. 10, 1995. Published May 1996. Available from Superintendent of Documents, U.S. Government Printing
2
Annual Book of ASTM Standards, Vol 13.01. Office, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 1672 – 95 (2000)
ISO 9001-Quality Systems-Model for Quality Assurance in 3.1.5 W —maximum medial-lateral width of the articulat-
1
Design/Development, Production, Installation, and Ser- ing surface in the frontal plane.
5
vicing 3.1.6 W —maximum medial-lateral width of the metal back
2
in the frontal plane.
3. Terminology
3.1.7 H —articulatingsurfacesuperior-inferiorheightinthe
1
frontal plane.
3.1 Definitions—Dimensions defined as follows are mea-
3.1.8 H —metal back superior-inferior height in the frontal
sured in whole or in part in the sagittal, transverse, and coronal
2
plane.
(or frontal) planes as appropriate. See Fig. 1 and Fig. 2.
3.1.9 Rc—radius of curvature for single radius axisymmet-
ric domes only.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 dome—a style of axisymmetric prosthesis that has a
single uniform radius of curvature (that is, button).
3.2.2 fixation element—any peg, keel, or other protrusion
from the nonarticulating side of the patellar component in-
tended to increase the surface contact
...

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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

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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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SIGNIFICANCE AND USE
A1.1 Significance and Use
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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