US · guidance
CMS SOM App. H, Tag V333
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR §
494.50(b)(1)
11.2 Rinsing/cleaning
11.2.3
Pre-cleaning the dialyzer (rinsing and cleaning) shall be done with a fluid or fluids made
with water that meets the requirements of these regulations related to allowable bacterial
and endotoxin levels.
Interpretive Guidance § 494.50(b)(1)
All water used for rinsing and reprocessing the dialyzer interior must meet the requirements of
AAMI RD52:2004 regarding allowable bacterial and endotoxin levels. Refer to § 494.140(a)
(V178) for details on microbial counts and endotoxin concentration levels . The interior of the
dialyzer should never be exposed to tap water. The facility must monitor the water supply to the
reprocessing station(s) for bacteria and endotoxins.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
ad74332b4347c53304d8c0426971d1371322151d4a0c2f77442fc3ff13eae9e2
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