ISO 15674:2001
Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Standard No.

ISO 15674:2001

Release Date

2001

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 15674:2009

Latest

ISO 15674:2016/Amd 1:2020

Scope

This International Standard specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a Wood reservoir during cardiopulmonary bypass (CPB) surgery. This International Standard applies only to the blood reservoir aspects for multifunctional systems which may have integral components such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.

ISO 15674:2001 history

• 2020 ISO 15674:2016/Amd 1:2020 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: Connectors
• 2016 ISO 15674:2016 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
• 2009 ISO 15674:2009 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
• 2001 ISO 15674:2001 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags