ASTM-F1800 › Historical Revision Information
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
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Scope
1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements. This standard covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover both the medial and lateral plateaus of the tibia. This test method may require modifications to accommodate other tibial tray designs.
1.2 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with one unsupported condyle.
1.3 The values stated in SI units are regarded as the standard. The inch-pound units given in parentheses are for information only.
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.
Keywords
arthroplasty; orthopaedic medical devices; tibial components; total knee arthroplasty; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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13.01 (Medical and Surgical Materials and Devices)
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Document Number
ASTM-F1800-97(2003)
Revision Level
1997 R03 EDITION
Status
Superseded
Modification Type
Reapproval
Publication Date
April 10, 2003
Document Type
Test Method
Page Count
5 pages
Committee Number
F04.22