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FDA-recognized standard · ObGyn/Gastroenterology/Urology

ISO 23500-1: Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements

Yes. FDA recognizes ISO 23500-1 Second edition 2024-08 as recognition 9-152, in part, entered 2026-05-25. FDA also lists ISO 23500-1 First edition 2019-02 (recognition 9-133, transition period ending 2028-07-02).

Recognized editions of ISO 23500-1

FDA recognitions of ISO 23500-1, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
9-152 ISO 23500-1 Second edition 2024-08 2026-05-25 Partial —
9-133 ISO 23500-1 First edition 2019-02
also ANSI AAMI ISO 23500-1:2019		 2021-06-07 Partial 2028-07-02

What FDA does not recognize in ISO 23500-1 Second edition 2024-08

Recognition 9-152 is partial. FDA's statement of the extent, verbatim:

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 7.5 Surveillance of concentrate distribution - Third paragraph, first sentence "There are no published reports of acid concentrate supporting bacterial growth; therefore, it is not necessary to perform routine testing for total viable microbial count and endotoxins on those systems." Section 8.2.3.4 Concentrate distribution systems - Second paragraph, third sentence "As there are no published reports of acid concentrate supporting bacterial growth, the disinfection of acid concentrate distribution systems is not normally required." Section B.5.3.2 Acid concentrate distribution systems - Last two sentences "Even though there are no published reports of acid concentrate supporting microbial growth, every effort should be made to keep the system closed to prevent contamination and evaporation. If the acid system remains intact, no rinsing or disinfection is necessary."

What FDA does not recognize in ISO 23500-1 First edition 2019-02

Recognition 9-133 is partial. FDA's statement of the extent, verbatim:

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 7.6 Surveillance of concentrate distribution - Third paragraph, first sentence "There are no published reports of acid concentrate supporting bacterial growth; therefore, it is not necessary to perform routine testing for total viable microbial count and endotoxins on those systems." Section 8.2.3.4 Concentrate distribution systems - Second paragraph, third sentence "As there are no published reports of acid concentrate supporting bacterial growth, the disinfection of acid concentrate distribution systems is not normally required." Section B.5.3.1 Acid concentrate distribution systems - Last two sentences "Even though there are no published reports of acid concentrate supporting microbial growth, every effort should be made to keep the system closed to prevent contamination and evaporation. If the acid system remains intact, no rinsing or disinfection is necessary."

Regulations

FDA lists these classification regulations against ISO 23500-1: 21 CFR 876.5665, 21 CFR 876.5820, 21 CFR 876.5860.

Product codes that cite ISO 23500-1

18 FDA product codes cite ISO 23500-1, including FIF, FII, FIJ, FIK, FIL.

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.