Norm

NEN-ISO 15676:2016 en

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

52,53

Over deze norm

Status Definitief
Aantal pagina's 8
Commissie Chirurgische implantaten
Gepubliceerd op 01-08-2016
Taal Engels
NEN-ISO 15676 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”. This document 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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