International Standard
ISO 15676:2016
Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
Reference number
ISO 15676:2016
Edición 2
2016-08
International Standard
Vista previa
ISO 15676:2016
66311
No disponible en español
Publicado (Edición 2, 2016)
Esta norma se revisó y confirmó por última vez en 2023. Por lo tanto, esta versión es la actual.

ISO 15676:2016

ISO 15676:2016
66311
Idioma
Formato
CHF 63
Convertir Franco suizo (CHF) a tu moneda

Resumen

ISO 15676:2016 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".

It 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.

Informaciones generales

  •  : Publicado
     : 2016-08
    : Norma Internacional confirmada [90.93]
  •  : 2
     : 8
  • ISO/TC 150/SC 2
    11.040.40 
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