US · guidance
CMS SOM App. H, Tag V324
Page 133 of 420
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR § 494.50
(b)(1)
7.2.2 Process control testing: methods established
7.2.2.1 Dialyzer test methods
Dialyzer test methods ([AAMI] 11.3) shall be established before clinical use of the
reprocessed dialyzers.
Verification of tests should be repeated after each significant change in the reprocessing
system. For automated systems, adherence to the manufacturer’s instructions can verify
the tests. For manual systems, confirmation of the accuracy of total cell volume (TCV)
measurement and the membrane integrity test can verify the tests.
Interpretive Guidance § 494.50(b)(1)
Process control enables users to verify that the equipment is functioning correctly. This can be
achieved by testing for the expected parameters (e.g., verifying the accuracy of the TCV
measurement) or by adhering to the manufacturer’s guidelines for automated equipment.
A “significant change” would include a change from a manual to an automated system, a
change from one automated system to another, a change in the germicide, or a major repair of
the reprocessing equipment.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
b6c16ce116ec69c048f1b920526d24bc6e35860882ab79730921c5d5c0ad30cb
The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.
Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.