ANSI/AAMI/ISO 15676:2016

ANSI/AAMI/ISO 15676:2016

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

Availability: In stock

€141.00

Details

Specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). 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. 24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as —sterile—. Annex 3

Additional Info

Author Association for the Advancement of Medical Instrumentation (AAMI)
Published by AAMI
Document type Standard
Theme Implants & Artificial Organs
Keyword ANSI/AAMI/ISO 15676:2016