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NEN-EN-ISO 7199

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

active, Most Current
Organization: NEN
Publication Date: 1 February 2017
Status: active
Page Count: 35
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

NEN-EN-ISO 7199 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

NEN-EN-ISO 7199
February 1, 2017
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
NEN-EN-ISO 7199 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)
NEN-EN-ISO 7199 + A1 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...

References

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