ASTM F1875-98(2004)
Historical Standard: ASTM F1875-98(2004) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
SUPERSEDED (see Active link, below)
ASTM F1875
1. Scope
1.1 This practice describes the testing, analytical, and characterization methods for evaluating the mechanical stability of the bore and cone interface of the head and stem junction of modular hip implants subjected to cyclic loading by measurements of fretting corrosion. (1-5) Two test methods described are as follows:
1.1.1 Method I-The primary purpose of this method is to provide a uniform set of guidelines for long-term testing to determine the amount of damage by measurement of the production of corrosion products and particulate debris from fretting and fretting corrosion. Damage also is assessed by characterization of the damage to the bore and cone surfaces. (4,5)
1.1.2 Methods II-This method provides for short-term electrochemical evaluation of the fretting corrosion of the modular interface. It is not the intent of this method to produce damage nor particulate debris but rather to provide a rapid method for qualitative assessment of design changes which do not include material changes. (1-4)
1.2 This practice does not provide for judgment or prediction of in vivo implant performance, but rather, provides for a uniform set of guidelines for evaluating relative differences in performance between differing implant designs, constructs, or materials with performance defined in the context of the amount of fretting and fretting corrosion. Also, this practice should permit direct comparison of fretting corrosion data between independent research groups, and thus, provide for building of a data base on modular implant performance.
1.3 This practice provides for comparative testing of manufactured hip femoral heads and stems and for coupon type specimen testing where the male taper portion of the modular junction does not include the entire hip implant, with the taper portion of the coupon identical in design, manufacturing, and materials to the taper of the final hip implant. (4,5)
1.4 Method I of this practice has been provided in a manner to permit simultaneous evaluation of the fatigue strength of a femoral hip stem (in accordance with Practice F1440) and the mechanical stability and debris generated by fretting and fretting corrosion of the modular interface.
1.5 The general concepts and methodologies described in this practice could be applied to the study of other modular interfaces in total joint prostheses.
1.6 This standard may involve 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
E4 Practices for Force Verification of Testing Machines
E466 Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F897 Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
F1440 Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
F1636 Specification for Bores and Cones for Modular Femoral Heads
G3 Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing
G5 Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements
G15 Terminology Relating to Corrosion and Corrosion Testing
G40 Terminology Relating to Wear and Erosion
G61 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements for Localized Corrosion Susceptibility of Iron-, Nickel-, or Cobalt-Based Alloys
G102 Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements
ISO Standards
ISO 7206-7 Endurance Performance of Stemmed Femoral Components Without Application of Torsion Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.Keywords
bore and cone; debris; fretting corrosion; modular total hips; Corrosion--surgical implants; Damage assessment--surgical applications; Fretting corrosion testing; Hip replacement prosthesis; Modular prostheses;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F1875-98R04
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