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Norm
ÖNORM EN ISO 7199
Issue date: 2020 10 01
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016 + Amd 1:2020) (consolidated version)
This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon di...
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Publisher:
Austrian Standards International
Format:
Digital | 40 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 7199
2020 10 01
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016 + ...
Norm
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ÖNORM EN ISO 7199
2017 04 01
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
Norm
ÖNORM EN ISO 7199
2014 12 01
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + ...
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