US · guidance
CMS SOM App. C, Tag D5405
§493.1251 Standard: Procedure manual
(c) Manufacturer’s test system instructions or operator manuals may be used, when
applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this
section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not
provided by the manufacturer must be provided by the laboratory.
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
1e432220c58c5108a50aaeb677b20feb1e9129de2c1a46df5fa2134ebc23bf8d
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