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ASTM F 732 : 2017 : REDLINE

Current

Current

The latest, up-to-date edition.

Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

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PDF

Language(s)

English

Published date

01-09-2017

CONTAINED IN VOL. 13.01, 2017 Specifies a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses.

Committee
F 04
DocumentType
Redline
Pages
15
PublisherName
American Society for Testing and Materials
Status
Current

1.1This test method describes a laboratory method for evaluating the wear properties of combinations of materials that are being considered for use as bearing surfaces of human total joint prostheses. The body of this test method contains general methods which apply to all types of prosthesis wear applications while individual annexes describe specific wear test methods and clinical validation criteria tailored to each distinct wear application (for example, linear reciprocating motion, ball-cup (“hip-type”) wear, delamination wear, and so forth). It is the intent of this test method to rank materials, within each wear application, for polymer wear rates under simulated physiological conditions. It must be recognized, however, that contact geometries and wear motions are simplified using such methods. This test method, therefore, represents only an initial stage in the full wear characterization of a candidate material.

1.2All candidate materials should be tested in an appropriate joint simulator apparatus using prototype prostheses before being used in clinical trials in patients. The tests described in this test method are used to quickly and reliably screen material combinations for wear performance in different orthopaedic wear applications prior to committing them to more expensive and time-consuming joint simulator testing. In addition, these simplified tests can be used to relate material, surface finish, or other parameters to wear behavior on a more practical basis than is possible in joint simulator tests.

1.3The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

1.4This 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.

S.R. CWA 17253-2:2018 JOINT IMPLANTS - PART 2: TIERED TOOLKIT APPROACH TO EVALUATE THE BIOLOGICAL IMPACT OF WEAR PARTICLES FROM JOINT REPLACEMENTS AND RELATED DEVICES
ASTM F 1714 : 1996 : R2013 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
DD ISO/TS 10993-19:2006 Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
ASTM F 2665 : 2009 Standard Specification for Total Ankle Replacement Prosthesis
ASTM F 1715 : 2000 Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices
ASTM F 2694 : 2016 : REDLINE Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
ASTM F 2665 : 2009 : R2014 Standard Specification for Total Ankle Replacement Prosthesis
ASTM F 1714 : 1996 : R2008 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
ASTM F 1877 : 2016 : REDLINE Standard Practice for Characterization of Particles
ASTM F 1672 : 2014 : REDLINE Standard Specification for Resurfacing Patellar Prosthesis
ASTM F 2887 : 2017 : REDLINE Standard Specification for Total Elbow Prostheses
ASTM G 115 : 2010 : R2013 Standard Guide for Measuring and Reporting Friction Coefficients
ASTM F 1714 : 1996 : R2002 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
ASTM F 2759 : 2011 : REDLINE Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
ASTM G 132 : 1996 Standard Test Method for Pin Abrasion Testing
ANSI/AAMI/ISO TIR10993-19:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
ASTM G 132 : 1996 : R2007 Standard Test Method for Pin Abrasion Testing
ASTM F 1714 : 1996 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
ASTM G 132 : 1996 : R2013 Standard Test Method for Pin Abrasion Testing
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ASTM F 2025 : 2006 : R2012 Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
ASTM F 2025 : 2006 Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
ASTM G 190 : 2015 Standard Guide for Developing and Selecting Wear Tests (Withdrawn 2021)
ASTM G 115 : 2010 Standard Guide for Measuring and Reporting Friction Coefficients
ASTM G 132 : 1996 : R2018 Standard Test Method for Pin Abrasion Testing
ASTM F 2083 : 2012 : REDLINE Standard Specification for Knee Replacement Prosthesis
ASTM G 132 : 1996 : R2001 Standard Test Method for Pin Abrasion Testing

ASTM F 86 : 2013 : REDLINE Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
ASTM F 1537 : 2011 : REDLINE Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
ASTM F 799 : 2011 : REDLINE SPECIFICATION FOR COBALT-28CHROMIUM-6MOLYBDENUM ALLOY FORGINGS FOR SURGICAL IMPLANTS (UNS R31537, R31538, R31539)
ASTM F 648 : 2014 : REDLINE Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

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