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  1. Home
  2. ISO 15676:2016

ISO 15676:2016 ✓ Most Recent

1925894  Preview

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

standard by International Organization for Standardization , 08/15/2016

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Identical Versions Available

  • BS ISO 15676:2016

    August 2016
    Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

    • This is the most recent version of this document.

Full Description

ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is 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. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile".

It is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.

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Document History

  1. ISO 15676:2016

    You are currently viewing this product 👀 currently
    viewing

    August 2016
    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

    • Most Recent  Most Recent
  2. ISO 15676:2005

    July 2005
    Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

    • Historical Version

Browse related products from International Organization for Standardization

  • International Organization for Standardization > By ICS Code > 11: Health care technology > 11.040: Medical equipment > 11.040.40: Implants for surgery, prosthetics and orthotics
  • International Organization for Standardization > By Technical Committee > TC 150: Implants for surgery > TC 150/SC 2: Cardiovascular implants and extracorporeal systems

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Published:

08/15/2016

File Size:

1 file

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BS ISO 15676:2016

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This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus
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