US · guidance
CMS SOM App. H, Tag V212
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.3.3 Water distribution systems (no added burden)
Product water distribution systems shall be constructed of materials that do not contribute
chemicals, such as aluminum, copper, lead, and zinc, or bacterial contaminants to the
purified water.
Interpretive Guidance § 494.40(a)
ANSI/AAMI RD52:2004
5.3.3 Water distribution systems
The choice of materials used for a water distribution system will also depend on the proposed
method of disinfection. Whatever material is used, care should be taken to select a product with
properties that provide the least favorable environment for bacterial proliferation, such as
smooth internal surface. [See table below.]
Page 75 of 420
Additional Guidance:
In the event a facility is using piping in the water distribution system which is not indicated as
compatible with the disinfectant in use per Table 2, responsible staff (medical director, chief
technician) should provide evidence that the disinfectant in use has been verified by the
manufacturer of the disinfectant or the 510(k) licensed disinfection device as compatible with
their distribution piping.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
382c96f383cda09a05fa88c5d2ed1a99fecf16c57528e3cfa7fce0853638313a
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