US · guidance
CMS SOM App. H, Tag V277
§ 494.40(e) - …The facility must meet all AAMI RD52:2004 requirements for water and
dialysate…
Interpretive Guidance § 494.40(e)
If the facility is using a preconfigured FDA-approved hemodialysis system for in-center
treatments, the facility must meet the requirements of ANSI/AAMI RD52:2004 in the use of that
system.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
9c7aa6e9086f7f1beabebeaf241f1772dc04d560f069c93b39c6435500158769
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