FDA-recognized standard · ObGyn/Gastroenterology/Urology
ISO 8637-1: Extracorporeal systems for blood purification -- Part 1: Haemodialysers haemodiafilters haemofilters and haemoconcentrators
Yes. FDA recognizes ISO 8637-1 First edition 2017-11 as recognition 9-118, in part, entered 2018-09-17.
Recognized editions of ISO 8637-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 9-118 | ISO 8637-1 First edition 2017-11 also ANSI AAMI ISO 8637-1:2017 | 2018-09-17 | Partial | — |
What FDA does not recognize in ISO 8637-1 First edition 2017-11
Recognition 9-118 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Section 6.2h Labelling on unit containers - a statement of sterility and non-pyrogenicity.
Regulations
FDA lists these classification regulations against ISO 8637-1: 21 CFR 876.5820, 21 CFR 876.5860.
Product codes that cite ISO 8637-1
6 FDA product codes cite ISO 8637-1, including FHS, FJG, FJI, FJJ, FKJ.
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.