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AAMI 15674

2016 Edition, September 2, 2016

Complete Document

Cardiovascular implants and artificial organs - Hard-shell cardiotomy/ venous reservoir systems (with/without filter) and soft venous reservoir bags



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SAME AS ISO 15674
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Description / Abstract:

This document specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.

This document applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.