ISO 7199:2024

ISO 7199:2024

September 2024
International standard Current

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

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.

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Main informations

Collections

International ISO standards

Publication date

September 2024

Number of pages

22 p.

Reference

ISO 7199:2024

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Print number

1
Sumary
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

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.

Replaced standards (2)
ISO 7199:2016
November 2016
International standard Cancelled
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

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.

ISO 7199/A1:2020
March 2020
International standard Cancelled
Amendment 1 to standard ISO 7199:2016

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