What is the FDA recognition number for ISO 8637-2?

9-140: ISO 8637-2 First Edition 2018-07 (partial recognition).

FDA-recognized standard · ObGyn/Gastroenterology/Urology

ISO 8637-2: Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers hemodiafilters and hemofilters

Yes. FDA recognizes ISO 8637-2 First Edition 2018-07 as recognition 9-140, in part, entered 2022-12-19.

Recognized editions of ISO 8637-2

FDA recognitions of ISO 8637-2, newest first (FDA database snapshot of 2026-09-01)
Recognition	Edition	Entered	Extent	Transition ends
9-140	ISO 8637-2 First Edition 2018-07 also ANSI AAMI ISO 8637-2:2018	2022-12-19	Partial	—

What FDA does not recognize in ISO 8637-2 First Edition 2018-07

Recognition 9-140 is partial. FDA's statement of the extent, verbatim:

Partial recognition. The following part(s) of the standard is (are) not recognized: The following part(s) of the standard is (are) not recognized: - Clause 4.4.9.1 Integral transducer protectors - Clause 4.4.9.2 Non-integral transducer protectors - Clause 5.5.6.1 Needle access ports - Clause 5.5.9 Transducer protectors - Clause 5.5.10 Blood pathway flow dynamics - Clause 5.5.11 Pump segment performance

Regulations

FDA lists these classification regulations against ISO 8637-2: 21 CFR 876.5820.

Product codes that cite ISO 8637-2

16 FDA product codes cite ISO 8637-2, including FIB, FID, FIF, FJK, FJP.

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.