FDA-recognized standard · Materials
ASTM E647: Standard Test Method for Measurement of Fatigue Crack Growth Rates
Yes. FDA recognizes ASTM E647-15 as recognition 8-404, entered 2016-04-04.
Recognized editions of ASTM E647
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-404 | ASTM E647-15 | 2016-04-04 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM E647: 21 CFR 888.3160, 21 CFR 888.3310, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3390, 21 CFR 888.3410, 21 CFR 888.3490, 21 CFR 888.3500, 21 CFR 888.3510, 21 CFR 888.3520, 21 CFR 888.3530, 21 CFR 888.3535, 21 CFR 888.3540, 21 CFR 888.3560, 21 CFR 888.3650, 21 CFR 888.3660, 21 CFR 888.3670, 21 CFR 888.3800, 21 CFR 888.3810.
Product codes that cite ASTM E647
36 FDA product codes cite ASTM E647, including HRY, HSX, JDB, JDI, JWH.
- HRY
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- JDB
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- JWI
- JWJ
- KMB
- KMC
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- KRR
- KTX
- KWM
- KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWZ
- KXE
- KYK
- LGE
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- MBL
- MBV
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- NJD
- NPJ
- OCG
- OIY
- OQG
- OQH
- OQI
- PAO
- PBI
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.