AAMI Products


ANSI/AAMI/ISO 15676:2016 (PDF)

Member Price: $80

Non-Member Price: $143

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”.

Date of Publication: 18 November 2016

Pages: 19

ISBN: 978-1-57020-638-2