US · guidance
CMS SOM App. H, Tag V217
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.3.4.3 Hot water disinfection systems
Refer to RD62:2001, 4.3.14 Hot water disinfection systems: When used to control bacterial
proliferation in water treatment, storage, and distribution systems, the water heater of a
hot water disinfection system should be capable of delivering hot water at the temperature
and for the exposure time specified by the manufacturer.
5.3.4.3 Hot water disinfection systems
Hot water disinfection systems can be used only in systems constructed from heat-resistant
materials, such as cross-linked polyethylene, polypropylene, and stainless steel (see [AAMI]
5.3.3).
The manufacturer’s instructions for using hot water disinfection systems should be
followed. If no manufacturer’s instructions are available, the effectiveness of the system
can be demonstrated by verifying that the system maintains a specified temperature for a
specified time and by performing ongoing surveillance with bacterial cultures and
endotoxin testing.
Page 81 of 420
Interpretive Guidance § 494.40(a)
ANSI/AAMI RD52:2004
5.3.4.3 Hot water disinfection systems
Hot water (≥80°C) may be used to control bacterial proliferation in water storage and
distribution systems. Bacterial kill studies are not required.
Additional Guidance:
See Table 2 at V212 for acceptable heat-resistant materials.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
3f872615ff05b6a2ec5328bc1fcf8f18b3b20ed0c93ca9978765dbd8c2828c5f
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