ASTM F1814-97a(2003)
Historical Standard: ASTM F1814-97a(2003) Standard Guide for Evaluating Modular Hip and Knee Joint Components
SUPERSEDED (see Active link, below)
ASTM F1814
1. Scope
1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.
1.2 This guide does not attempt to define all test methods associated with modular device evaluation.
1.3 This guide does not cover intentional intraoperative diassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads.
1.4 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
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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
F1800 Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Keywords
arthroplasty; disassembly; hip arthroplasty; knee arthroplasty; modular; orthopaedic medical devices; Arthroplasty; Corrosion--surgical implants; Disassembly; Hip replacement prosthesis--specifications; Knee replacement prosthesis--specifications; Modular prostheses; Orthopaedic medical devices--specifications; Sterilization;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F1814-97AR03
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