ISO 15674:2016 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.
It 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 : PublishedPublication date : 2016-08
Edition : 3Number of pages : 11
Technical Committee:Cardiovascular implants and extracorporeal systems
Buy this standard
|PDF + ePub|