ISO 15676:2005 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). ISO 15676:2005 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 ISO 15676:2005 are applicable to tubing packs labelled as "sterile".
ISO 15676:2005 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.
Текущий статус : WithdrawnДата публикации : 2005-07
Версия : 1
Технический комитет:Cardiovascular implants and extracorporeal systems