NF EN ISO 7199

NF EN ISO 7199

September 2024
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

National standards and national normative documents

Publication date

September 2024

Number of pages

36 p.

Reference

NF EN ISO 7199

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment
11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S93-300

Print number

1

International kinship

ISO 7199:2024

European kinship

EN ISO 7199:2024
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)
NF EN ISO 7199
December 2017
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.

NF EN ISO 7199/A1
April 2020
Standard Cancelled
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - AMENDMENT 1 : connectors

Le présent document amende et modifie le paragraphe 4.2.4, l'Article 2, l'Annexe A et la Bibliographie.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Essais et mesurages visant à déterminer la conformité au présent document
  • 6 Informations fournies par le fabricant
  • 7 Emballage
  • A Exemples de raccords
  • Bibliographie
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