Resumen
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.
Informaciones generales
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Estado: En desarrolloEtapa: Texto final recibido o FDIS registrado para su aprobación formal [50.00]
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Edición: 4Número de páginas: 22
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Comité Técnico :ISO/TC 150/SC 2ICS :11.040.40
- RSS actualizaciones
Ciclo de vida
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Anteriormente
PublicadoISO 7199:2016
PublicadoISO 7199:2016/Amd 1:2020
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Ahora
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