FDA-recognized standard · ObGyn/Gastroenterology/Urology
ISO 23500-3: Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
Yes. FDA recognizes ISO 23500-3 Second edition 2024-04 as recognition 9-154, entered 2026-05-25. FDA also lists ISO 23500-3 First edition 2019-02 (recognition 9-135, transition period ending 2028-07-02).
Recognized editions of ISO 23500-3
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 9-154 | ISO 23500-3 Second edition 2024-04 | 2026-05-25 | Complete | — |
| 9-135 | ISO 23500-3 First edition 2019-02 also ANSI AAMI ISO 23500-3:2019 | 2021-06-07 | Complete | 2028-07-02 |
Regulations
FDA lists these classification regulations against ISO 23500-3: 21 CFR 876.5630, 21 CFR 876.5665, 21 CFR 876.5820, 21 CFR 876.5860.
Product codes that cite ISO 23500-3
18 FDA product codes cite ISO 23500-3, including FIF, FII, FIJ, FIK, FIL.
- FIF
- FII
- FIJ
- FIK
- FIL
- FIP Subsystem, Water Purification
- FKH
- FKO
- FKP
- FKR
- FLB
- KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- MNV
- NHV
- NIH
- NII
- NNG
- NTZ
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.