AAMI 15674
Cardiovascular implants and artificial organs - Hard-shell cardiotomy/ venous reservoir systems (with/without filter) and soft venous reservoir bags
Organization: | AAMI |
Publication Date: | 2 September 2016 |
Status: | active |
Page Count: | 21 |
scope:
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.