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BSI BS ISO 15676:2016

Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
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BSI BS ISO 15676:2016

Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

PUBLISH DATE 2016
PAGES 20
BSI BS ISO 15676:2016

This document 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.

SDO BSI: British Standards Institution
Document Number ISO 15676
Publication Date Aug. 31, 2016
Language en - English
Page Count
Revision Level
Supercedes
Committee CH/150/2
Publish Date Document Id Type View
Aug. 31, 2016 BS ISO 15676:2016 Revision