US · guidance
CMS SOM App. H, Tag V350
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
12.3.1 Presence test of each hemodialyzer
The presence of germicide may be ensured by directly testing each dialyzer for the
presence of germicide. Certain germicide manufacturers require this testing before the
germicide is rinsed from the hemodialyzer, and these instructions should be followed.
Interpretive Guidance § 494.50(b)(1)
Manufacturers of peracetic acid and glutaraldehyde require every dialyzer be tested for
presence of a sufficient concentration of germicide after storage and before use.
The test for germicide presence (at the potency recommended by the germicide manufacturer)
should be done before rinsing and priming.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
54582b827805d21888e8b5dc1fbf1fda39e19e20924da4ae3bc4e7eb2dd181fe
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