Abstract

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.

Begin

2021-06-22

WI

00205365

Planned document number

DIN EN ISO 7199

Project number

06302092

Responsible national committee

NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 150/SC 2/WG 4 - Blood gas exchangers  

draft standard

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023); German and English version prEN ISO 7199:2023
2023-08
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previous edition(s)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016 + Amd 1:2020); German version EN ISO 7199:2017 + A1:2020
2020-10

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