| ASTM F1160-14 (Reapproved 2017)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| Recognition Number | Materials |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 8-380 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Materials |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This test method covers the procedure for determining the shear and bending fatigue performance of calcium phosphate coatings and of porous and nonporous metallic coatings and for determining the bending fatigue performance of metallic coatings over sprayed with calcium phosphate. This test method has been established based on plasma-sprayed titanium and plasma-sprayed hydroxylapatite coatings. The efficacy of this test method for other coatings has not been
established. In the shear fatigue mode, this test method evaluates the adhesive and cohesive properties of the coating on a metallic substrate. In the bending fatigue mode, this test method evaluates both the adhesion of the coating as well as the effects that the coating may have on the substrate material. These methods are limited to testing in air at ambient temperature. These test methods are not intended for application in fatigue tests of components or devices; however, the test method which most closely replicates the actual loading configuration is preferred.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3565 | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class 2 | MBH |
| §888.3358 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class 2 | LPH |
| §888.3358 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class 2 | MBL |
| Guidance Document for Testing Orthopaedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement, Issued April 1994. |