US · guidance
CMS SOM App. H, Tag V229
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.4.4.1 Mixing systems (permanent records)
6.4.1 Mixing systems (verification testing)
5.4.4.1 Mixing systems
In addition to container labeling, there should be permanent records of batches produced.
These records should include the concentrate formula produced, the volume of the batch,
the lot numbers of powdered concentrate packages, the manufacturer of the powdered
concentrate, the date and time of mixing, any test results, the person performing the
mixing, the person verifying mixing and test results, and the expiration date (if applicable).
6.4.1 Mixing systems
Acid and bicarbonate concentrates may be tested by using conductivity or by using a
hydrometer.
Concentrates should not be used or transferred to holding tanks or distribution systems
until all tests are completed. The test results and verification that they meet all applicable
criteria should be recorded and signed by the individuals performing the tests.
Interpretive Guidance § 494.40(a)
ANSI/AAMI RD52:2004
6.4.1 Mixing systems
Page 89 of 420
Although not required, some manufacturers may provide allowable ranges for either the
conductivity or the specific gravity of concentrates prepared from their powder. The use of pH as
an indicator of proper dissolution is inappropriate for both acid and bicarbonate concentrates,
because large variations in concentration do not produce significant changes in pH.
Additional Guidance:
The mixing logs should demonstrate complete documentation of this required information. Test
results may include conductivity or specific gravity. Facility policy must stipulate the expected
ranges for the test(s) used to verify correct mixing. Standards used to calibrate the instrument
used to measure conductivity should encompass the expected results; for example, it would be
unacceptable to use a “14” standard for an expected result of “70.” “Verifying mixing and test
results” means the staff member performing this task checks the results against the expected
ranges for the test and does not release mixtures for use that test outside those ranges.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
4d31abd51df4c174092bc66270356a8363538e63de9a6c6c3585e79ae626a1c9
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