ISO-15676 › Historical Revision Information
Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
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ISO 15676:2005 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.
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Document Number
ISO 15676:2005
Revision Level
1ST EDITION
Status
Superseded
Publication Date
July 15, 2005
Committee Number
ISO/TC 150/SC 2