1.1 This practice covers two procedures for burst testing of ceramic femoral components used in total knee replacements (TKR). This practice covers the procedures for the performance of ultimate strength on ceramic femoral knee components using a constant stroke rate. It applies to cruciate retaining (CR) femoral components which cover both the medial and lateral condyles and the patellar surface of the femur. This practice may require modifications to accommodate other femoral component designs. 1.2 This practice is intended to provide useful, consistent, and reproducible information about the ultimate strength performance of ceramic femoral components. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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.
This NEW standard includes two test methods intended to assess the ultimate strength of ceramic femoral knee components. This information can be used for evaluation of different component designs or for series production control.
The title and scope are in draft form and are under development within this ASTM Committee.
Date Initiated: 03-18-2019
Technical Contact: Roman Preuss
Item: 001
Ballot: F04.22 (21-01)
Status: Will Reballot Item
Item: 007
Ballot: F04 (22-02)
Status: Will Reballot Item
Item: 001
Ballot: F04.22 (19-02)
Status: Will Reballot Item
Item: 001
Ballot: F04.22 (20-03)
Status: Will Reballot Item
Item: 008
Ballot: F04 (21-08)
Status: Will Reballot Item
Item: 004
Ballot: F04 (22-07)
Status: In Balloting