ISO 15674:2016Published

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

Implants cardiovasculaires et organes artificiels — Systèmes réservoirs de cardiotomie/veineux à paroi dure (avec/sans filtre) et sacs réservoirs veineux mous

Abstract / scope

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.

Life cycle

Amendments & corrigenda

ISO 15674:2016/Amd 1:2020PublishedCardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: ConnectorsInternational Standard · Published 17 Feb 2020 · ISO/TC 150/SC 2

Replaces

ISO 15674:2009WithdrawnCardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bagsInternational Standard · Published 30 Mar 2009 · ISO/TC 150/SC 2