US · guidance
CMS SOM App. H, Tag V337
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR §
494.50(b)(1)
11.3.3 Blood path integrity test
A membrane integrity test such as an air pressure leak test shall be done between uses.
Interpretive Guidance § 494.50(b)(1)
AAMI Rationale for the Development and Provisions of this Recommended Practice
A.11.3.3 Blood path integrity test
The 1986 edition of the AAMI recommended practice did not include a blood path integrity test.
Following recommendations from the Centers for Disease Control and Prevention (CDC), the
AAMI RDD Committee agreed to add this test to the second edition of the recommended
practice. This test is based on the observation that only a small amount of air leaks through
wetted membranes, resulting in a pressure drop of less than 10% of the test pressure. A
maximum allowable pressure drop is not given because of variations among test systems and
dialyzers.
Additional Guidance:
Recognize that manual reprocessing systems may require each dialyzer be tested separately.
Automated systems must include the pressure leak test in the method and apparatus used for
testing the integrity a dialyzer prior to its reuse.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
8b7b61b243198a10bb78b3dd6f44e0ba0f4dbc36838143e566aa413fb704e89d
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