US · guidance
CMS SOM App. H, Tag V223
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.4 Concentrate preparation
5.4.2 Materials compatibility
All components used in concentrate preparation systems (including mixing and storage
tanks, pumps, valves, and piping) shall be fabricated from materials (e.g., plastics or
appropriate stainless steel) that do not interact chemically or physically with the
concentrate so as to affect its purity, or with the germicides or germicidal procedure used
to disinfect the equipment. The use of materials that are known to cause toxicity in
hemodialysis, such as copper, brass, galvanized material, and aluminum, are specifically
prohibited.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
cc876dc30a11657039ed1132564df6916112279448af1a08fd5402547e9a94c6
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