90.93 Standard confirmed May 2, 2023
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
Published
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.
WITHDRAWN
ISO 15674:2009
PUBLISHED
ISO 15674:2016
90.93
Standard confirmed
May 2, 2023
PUBLISHED
ISO 15674:2016/Amd 1:2020