DIN EN ISO 7199:2020 Edition

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

Published By	Publication Date	Number of Pages
DIN	2020-10	39

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, DIN

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Description

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 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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2020-10
Pages Count	39
Language	Germany
Descriptors	Artificial organs, Blood, Blood-gas exchangers (oxygenators), Cardiology, CE marking, Connections, Connectors, Definitions, In vitro, Marking, Medical products, Medical technology, Oxygenators, Packages, Physical properties, Properties, Surgical implants, Testing, Vascular system, Medical devices, Lines
File Size	2.9 MB
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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DIN EN ISO 7199:2020 Edition

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