US · guidance
CMS SOM App. H, Tag V237
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.5 Concentrate distribution:
5.5.1 Materials compatibility
All components used in concentrate distribution systems (including concentrate jugs,
storage tanks, and piping) that contact the fluid shall be fabricated from nonreactive
materials (e.g., plastics or appropriate stainless steel) that do not interact chemically or
physically with the concentrate so as to affect its purity. 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
3e5dffa12a571b2a781cb6eb94cc0140ba36142a65d4f2acea1469606c1f3676
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