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CEN - EN ISO 7199

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors

active, Most Current
Organization: CEN
Publication Date: 1 January 2017
Status: active
Page Count: 36
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This document 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.

This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.

This document also applies to external equipment unique to the use of the oxygenator.

This document does not apply to

- implanted oxygenators,

- liquid oxygenators,

- extracorporeal circuits (blood tubing),

- separate heat exchangers,

- separate ancillary devices, and

- separate arterial line filter.

Document History

EN ISO 7199
January 1, 2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors
This document 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...
January 1, 2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
This document 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...
August 1, 2014
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
This I nternational Standard specifies r equirements f or sterile, single-use, e xtracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from,...

References

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