Standard: AAMI 15676

CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS-REQUIREMENTS FOR SINGLEUSE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)

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Scope:

This document specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (longterm, i.e. >24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”.

This document is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 15676
Publish Date: 2016-09-02
Page Count: 19
Change Type: NEW ADDITION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active
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