AAMI/ISO 7199:2016

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. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”.

Published:

11/18/2016

ISBN(s):

9781570206559

ANSI:

ANSI Approved

Number of Pages:

24

File Size:

1 file , 240 KB

Same As:

AAMI/ISO 7199:2016

Note:

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