scope:

This International Standard specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This International Standard 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 (shortterm, i.e. duration) CPB surgery, or (long-term, i.e. ) ECMO procedures. The sterility and nonpyrogenicity provisions of this International Standard are applicable to tubing packs labelled as "sterile". This International Standard 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.