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ISO 7199:2016

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

standard by International Organization for Standardization , 11/15/2016

📝 Amendments Available

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About This Item

 

Full Description

ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.

ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.

ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.

ISO 7199:2016 does not apply to

- implanted oxygenators,

- liquid oxygenators,

- extracorporeal circuits (blood tubing),

- separate heat exchangers,

- separate ancillary devices, and

- separate arterial line filter.

 

Product Details

Published:
11/15/2016
File Size:
1 file , 520 KB
Same As:
DIN EN ISO 7199
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 7199:2016


    Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

    • Historical Version

  2. ISO 7199:2016

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    Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

    • Most Recent

  3. ISO 7199:2009


    Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

    • Historical Version

  4. ISO 7199:1996


    Cardiovascular implants and artificial organs -- Blood-gas exchangers (oxygenators)

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 7199:2016/Amd1:2020


    - Amendment 1: Connectors