ISO 15674:2009

Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags ISO 15674:2009

Publication date:   Mar 30, 2009

Scope

ISO 15674:2009 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.
ISO 15674:2009 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.