| ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 8-404 |
| 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 method2 covers the determination of fatigue crack growth rates from near-threshold to Kmax controlled instability. Results are expressed in terms of the crack-tip stress-intensity factor range (ΔK), defined by the theory of linear elasticity.
1.2 Several different test procedures are provided, the optimum test procedure being primarily dependent on the magnitude of the fatigue crack growth rate to be measured.
1.3 Materials that can be tested by this test method are not limited by thickness or by strength so long as specimens are of sufficient thickness to preclude buckling and of sufficient planar to remain predominantly elastic during testing.
1.4 A range of specimen s with proportional planar dimensions is provided, but is variable to be adjusted for yield strength and applied force. Specimen thickness may be varied independent of planar .
1.5 The details of the various specimens and test configurations are shown in Annex A1 - Annex A3. Specimen configurations other than those contained in this method may be used provided that well-established stress-intensity factor calibrations are available and that specimens are of sufficient planar to remain predominantly elastic during testing.
1.6 Residual stress/crack closure may significantly influence the fatigue crack growth rate data, particularly at low stress-intensity factors and low stress ratios, although such variables are not incorporated into the computation of ΔK.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3810 | Prosthesis, Wrist, Hemi-, Ulnar | Class 2 | KXE |
| §888.3800 | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | Class 2 | JWI |
| §888.3800 | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Class 2 | JWJ |
| §888.3800 | Prosthesis, Wrist, Semi-Constrained | Class 2 | KWM |
| §888.3670 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | MBF |
| §888.3660 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Class 2 | PAO |
| §888.3660 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class 2 | KWS |
| §888.3650 | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class 2 | KWT |
| §888.3410 | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented | Class 3 | OCG |
| §888.3560 | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | NPJ |
| §888.3560 | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | Class 2 | MBV |
| §888.3560 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class 2 | OIY |
| §888.3560 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | JWH |
| §888.3540 | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | KRR |
| §888.3535 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | Class 2 | NJD |
| §888.3530 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | HRY |
| §888.3530 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing | Class 2 | LGE |
| §888.3520 | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class 2 | HSX |
| §888.3510 | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class 2 | KRO |
| §888.3500 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite | Class 2 | KYK |
| §888.3490 | Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented | Class 2 | KTX |
| §888.3490 | Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented | Class 2 | KMB |
| §888.3390 | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | KWY |
| §888.3358 | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class 2 | OQG |
| §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 |
| §888.3353 | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class 2 | OQI |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Class 2 | MAY |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | LZO |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class 2 | MEH |
| §888.3350 | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Class 2 | OQH |
| §888.3350 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class 2 | JDI |
| §888.3340 | Prosthesis, Hip, Semi-Constrained, Composite/Metal | Class 2 | KMC |
| §888.3310 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class 2 | KWZ |
| §888.3310 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | Class 2 | PBI |
| §888.3160 | Prosthesis, Elbow, Semi-Constrained, Cemented | Class 2 | JDB |
| There is no relevant guidance developed at this time. |