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About This Item

 

Full Description

ISO 15674:2016 specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.

It applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.

 

Document History

  1. ISO 15674:2016

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    Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

    • Most Recent
  2. ISO 15674:2009


    Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

    • Historical Version
  3. ISO 15674:2001


    Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 15674:2016/Amd1:2020


    - Amendment 1: Connectors