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  • BSI
    BS EN ISO 7199:2024 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
    Edition: 2024
    $435.35
    / user per year

Description of BS EN ISO 7199:2024 2024

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange. 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 filters.

Standard NumberBS EN ISO 7199:2024
TitleCardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
StatusDefinitive
Publication Date2024-10-25
ReplacesBS EN ISO 7199:2016+A1:2020
Identical National Standard OfISO 7199:2024, EN ISO 7199:2024
DescriptorsOxygen, Performance testing, Circulatory system, Carbon dioxide, Blood, Instructions for use, Heat exchangers, Sterile equipment, Medical equipment, Performance, Artificial organs, Artificial lungs
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 539 18478 5
PublisherBSI
Pages32

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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