ISO 15676:2016

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

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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)

PUBLISH DATE 2016
ISO 15676:2016

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.

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