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:
- 11/16/2016
- ISBN(s):
- 9781570206382
- ANSI:
- ANSI Approved
- Number of Pages:
- 21
- File Size:
- 1 file , 230 KB
- Note:
- This product is unavailable in Ukraine, Russia, Belarus
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