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.
Status: WithdrawnPublication date: 2009-04
Edition: 2Number of pages: 9
Technical Committee: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems