Aktivní norma | Vydána: 15.08.2016

ISO 15676:2016-ed.2.0

Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
(Implants cardiovasculaires et organes artificiels — Exigences pour les paquets de tubes a usage unique pour pontage cardiopulmonaire et oxygénation des membranes extracorporelles)

Dostupné jazyky: Anglicky

Dostupné provedení: Elektronické PDF, Tištěné

od 2 114.10 CZK zobrazit na eshopu

Podrobné informace

Označení: ISO 15676:2016-ed.2.0

Datum vydání: 15.08.2016

Stran: 8

Země: Mezinárodní technická norma

Kde koupit?

Můžete zakoupit na eshop.normservis.cz

Anotace

Description / Abstract: 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.

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