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AAMI/ISO 7199:2016

Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 11/18/2016

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Full Description

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".
 

Product Details

Published:
11/18/2016
ISBN(s):
9781570206559
ANSI:
ANSI Approved
Number of Pages:
24
File Size:
1 file , 240 KB
Same As:
ISO 7199:2016, BS EN ISO 7199:2017
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 7199:2016

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    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)

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  2. AAMI/ISO 7199:2009


    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)

    • Historical Version

  3. AAMI BG7199


    Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)

    • Historical Version