FDA-recognized standard · Materials
ISO 11542-2: Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
Yes. FDA recognizes ISO 11542-2 First edition 1998-11-15 as recognition 8-379, entered 2014-07-09.
Recognized editions of ISO 11542-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-379 | ISO 11542-2 First edition 1998-11-15 | 2014-07-09 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 11542-2: 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 ISO 11542-2
36 FDA product codes cite ISO 11542-2, 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.