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Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
Description
Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags1 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.
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