Norm

NEN-ISO 15676:2005 en

Cardiovasculaire implantaten en kunstmatige organen - Eisen aan buizenbundels voor eenmalig gebruik voor cardiopulmonale bypass en extracorporale membraan oxygenatie (ECMO)

  • Deze norm is ingetrokken sinds 25-08-2016

48,19

Over deze norm

Status Ingetrokken
Aantal pagina's 8
Commissie Chirurgische implantaten
Gepubliceerd op 01-08-2005
Taal Engels
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.

Details

ICS-code 11.040.40
Nederlandse titel Cardiovasculaire implantaten en kunstmatige organen - Eisen aan buizenbundels voor eenmalig gebruik voor cardiopulmonale bypass en extracorporale membraan oxygenatie (ECMO)
Engelse titel Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
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