FDA-recognized standard · Orthopedic
ISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
Yes. FDA recognizes ISO 14242-1 Third edition 2014-10-15 as recognition 11-352, entered 2019-07-15.
Recognized editions of ISO 14242-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-352 | ISO 14242-1 Third edition 2014-10-15 | 2019-07-15 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 14242-1: 21 CFR 888.3300, 21 CFR 888.3310, 21 CFR 888.3320, 21 CFR 888.3330, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3360, 21 CFR 888.3390, 21 CFR 888.3410.
Product codes that cite ISO 14242-1
23 FDA product codes cite ISO 14242-1, including JDI, JDL, KMC, KWA, KWY.
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDL
- KMC
- KWA
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWZ
- KXB
- KXD
- LPF
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJ
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBL
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MRA
- NXT
- OCG
- OQG
- OQH
- OQI
- OVO
- 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.