US · guidance
CMS SOM App. H, Tag V227
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
6.4.1 Mixing systems (self-designed)
If a facility designs its own system, procedures should be developed and demonstrated to
ensure proper mixing of the concentrate, including establishment of acceptable limits for
tests of proper concentration. The adequacy of those procedures must be verified using an
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independent laboratory that is capable of meeting the requirements of ANSI/AAMI
RD61:2000 (see 2.4). Verification can be accomplished by testing a sample from each batch
prepared over a 3-day period.
Interpretive Guidance § 494.40(a)
If a facility designs its own mixing systems, there must be documentation of the verification
testing available for review.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
c310583c15c45ce463c347443de28b166a79bb7ab16911e07c600475189cc0bc
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