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ISO 15676:2016

Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

Publication date:   Aug 15, 2016

General information

90.93 Standard confirmed   May 26, 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 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile".
It is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15676:2005

NOW

PUBLISHED
ISO 15676:2016
90.93 Standard confirmed
May 26, 2023