US · guidance
CMS SOM App. H, Tag V247
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.5.5 Concentrate outlets (designated outlets and labeling)
6.5 Concentrate distribution
5.5.5 Concentrate outlets: separate/labeled/connection safety
To prevent mix-ups with delivery of two or more types of acid concentrate, each
concentrate should have its own outlet. Concentrate outlets should be compatible with the
dialysis machine and have a means of minimizing the risk that the wrong concentrate will
be connected to an outlet. The dispensing outlets should be labeled with the appropriate
symbol (see AAMI Table 3) indicating the proportioning ratio for the dialysis machine and
should be color-coded blue for bicarbonate, red for acid.
6.5 Concentrate distribution
A daily check to ensure that the appropriate acid and bicarbonate concentrate is connected
to the corresponding concentrate delivery line is recommended if the storage tank is not
permanently connected to its distribution piping.
Interpretive Guidance § 494.40(a)
Page 100 of 420
ANSI/AAMI RD52:2004
5.5.5 Concentrate outlets
For piped concentrate distribution systems, each treatment station is equipped with a
concentrate outlet for bicarbonate, one or more outlets for acid concentrate, and a product
water outlet for connection to the inlet line of the dialysis machine.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
2819c524e37dfde6ddd09c691fcec5ae2dc1806414787b8001f24d204cb12a47
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