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ISO 15674:2016

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

Publication date:   Aug 15, 2016

General information

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

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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

PREVIOUSLY

WITHDRAWN
ISO 15674:2009

NOW

PUBLISHED
ISO 15674:2016
90.93 Standard confirmed
May 2, 2023

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 15674:2016/Amd 1:2020