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Normas DIN – AENOR
DIN EN ISO 7199:2015-06

DIN EN ISO 7199:2015-06

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2015); German and English version prEN ISO 7199:2015 / Note: Date of issue 2015-05-15

Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels (oxygénateurs) (ISO/DIS 7199:2015); Version allemande et anglaise prEN ISO 7199:2015 / Attention: Date de parution 2015-05-15

Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren) (ISO/DIS 7199:2015); Deutsche und Englische Fassung prEN ISO 7199:2015 / Achtung: Erscheinungsdatum 2015-05-15

Fecha Anulación:
2017-05 /Withdrawn
Equivalencias internacionales:

ISO/DIS 7199 (2015-05)

prEN ISO 7199 (2015-05)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 7199:2017-05

Resumen:
This doocument 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 that are integral parts of oxygenators and to external equipment unique to the use of the device. This document does not apply to: implanted oxygenators; liquid oxygenators; extracorporeal circuits (blood tubing); separate heat exchangers; separate ancillary devices.
Keywords:
Artificial organs, Blood, Blood-gas exchangers (oxygenators), Cardiology, Definitions, In vitro, Marking, Medical technology, Oxygenators, Packages, Physical properties, Properties, Surgical implants, Testing, Vascular system
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