US · guidance
CMS SOM App. H, Tag V206
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
6.2.8 Deionization (chemical analysis: frequency)
When deionization is employed as the primary method for removing inorganic
contaminants (reverse osmosis is not employed), or when deionization is necessary to polish
RO-treated water, chemical analyses to ensure that the requirements of AAMI 4.1.1 (Table
1) are met should be performed when the system is installed and at annual intervals
thereafter.
Interpretive Guidance § 494.40(a)
Samples for chemical analysis should be drawn after the last treatment component; if the water
treatment system includes DI as primary or polish, the routine chemical analysis samples should
be taken after the DI. Taking the sample from the last patient treatment station would also meet
this requirement.
Page 69 of 420
Note: requirements for preconfigured systems, which may include DI, are given at V276.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
41e072f0b359f18d5f50f4d83fd6ab1d9ac4a90510aa9a4e0f0fd3b22c620d3d
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