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SIST EN ISO 7199:2024

(Main)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024)

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.

Kardiovaskuläre Implantate und künstliche Organe - Blut-Gas-Austauscher (Oxygenatoren) (ISO 7199:2024)

Dieses Dokument legt Anforderungen an sterile extrakorporale Blutgasaustauscher (Oxygenatoren) zum Einmalgebrauch fest, die zur Zufuhr von Sauerstoff in und zur Entfernung von Kohlendioxid aus Humanblut während des kardiopulmonalen Bypasses (CPB) für bis zu 6 h, der extrakorporalen Lungenunterstützung (ECLA mit venen-venen (VV)-, venen-arteriell (VAV)- oder Venen-arteriell-venöse (VAV)-Kanülierungsstrategien), der kardiopulmonalen Unterstützung (CPS), der extrakorporalen Lebensunterstützung (ECLS mit VA-Kanülierungsstrategie), der extrakorporalen Kohlendioxidentfernung (ECCO2R) und anderer extrakorporaler Kreislauftechniken, die einen Blut-Gas-Austausch erfordern bestimmt sind.
Dieses Dokument ist auch anwendbar für Wärmeaustauscher und arterielle Filter, die in Oxygenatoren integriert sind.
Dieses Dokument ist auch anwendbar für Außengeräte, die allein für den Gebrauch mit dem Oxygenator bestimmt sind.
Dieses Dokument ist nicht anwendbar für:
-   implantierte Oxygenatoren;
-   Flüssigkeits-Oxygenatoren;
-   extrakorporale Kreisläufe (Blutschlauchsysteme);
-   separate Wärmeaustauscher;
-   separate Hilfsgeräte; und
-   separate arterielle Filterleitungen.

Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang (oxygénateurs) (ISO 7199:2024)

L'ISO 7199:2016 précise les prescriptions relatives aux échangeurs gaz/sang extracorporels stériles (oxygénateurs), à usage unique, destinés à oxygéner le sang des patients et à en éliminer le dioxyde de carbone.
L'ISO 7199:2016 s'applique également aux échangeurs thermiques et aux filtres artériels qui font partie intégrante des oxygénateurs.
Il s'applique aussi à l'équipement externe propre à l'utilisation de l'oxygénateur.
L'ISO 7199:2016 ne s'applique pas aux:
- oxygénateurs implantés,
- oxygénateurs liquides,
- circuits extracorporels (tubulures pour le sang),
- échangeurs thermiques non intégrés,
- dispositifs annexes distincts, et
- filtres de ligne artérielle distincts.

Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov (oksigenatorji) (ISO 7199:2024)

Standard ISO 7199:2016 določa zahteve za sterilne zunajtelesne izmenjevalnike krvnih plinov (oksigenatorje) za enkratno uporabo, ki so namenjeni za dovajanje kisika in odvajanje ogljikovega dioksida iz človeške krvi.
Standard ISO 7199:2016 se uporablja tudi za izmenjevalnike toplote in arterijske filtre, ki so sestavni deli oksigenatorja,
ter za zunanjo opremo, namenjeno izključno za uporabo oksigenatorja.
Standard ISO 7199:2016 se ne uporablja za:
– vsajene oksigenatorje,
– tekoče oksigenatorje,
– zunajtelesne obtoke (cevke za kri),
– ločene izmenjevalnike toplote,
– ločene pomožne pripomočke in
– ločene arterijske filtre.

General Information

Status
Published
Public Enquiry End Date
08-Oct-2023
Publication Date
22-Sep-2024
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Sep-2024
Due Date
24-Nov-2024
Completion Date
23-Sep-2024
Ref Project
EN ISO 7199:2024 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024)

Relations

Replaces
SIST EN ISO 7199:2017 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
Effective Date
01-Nov-2024
Replaces
SIST EN ISO 7199:2017/A1:2020 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)
Effective Date
01-Nov-2024

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SLOVENSKI STANDARD
01-november-2024
Nadomešča:
SIST EN ISO 7199:2017
SIST EN ISO 7199:2017/A1:2020
Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov
(oksigenatorji) (ISO 7199:2024)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO
7199:2024)
Kardiovaskuläre Implantate und künstliche Organe - Blut-Gas-Austauscher
(Oxygenatoren) (ISO 7199:2024)
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang (oxygénateurs)
(ISO 7199:2024)
Ta slovenski standard je istoveten z: EN ISO 7199:2024
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 7199
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 7199:2017
English Version
Cardiovascular implants and artificial organs - Blood-gas
exchangers (oxygenators) (ISO 7199:2024)
Implants cardiovasculaires et organes artificiels - Kardiovaskuläre Implantate und künstliche Organe -
Échangeurs gaz/sang (oxygénateurs) (ISO 7199:2024) Blut-Gas-Austauscher (Oxygenatoren) (ISO 7199:2024)
This European Standard was approved by CEN on 10 August 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7199:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7199:2024) has been prepared by Technical Committee ISO/TC 150 "Implants
for surgery" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2025, and conflicting national standards shall
be withdrawn at the latest by March 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7199:2017.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 7199:2024 has been approved by CEN as EN ISO 7199:2024 without any modification.

International
Standard
ISO 7199
Fourth edition
Cardiovascular implants and
2024-09
artificial organs — Blood-gas
exchangers (oxygenators)
Implants cardiovasculaires et organes artificiels — Échangeurs
gaz/sang (oxygénateurs)
Reference number
ISO 7199:2024(en) © ISO 2024
ISO 7199:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 7199:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 4
4.1 Biological characteristics .4
4.1.1 Sterility and non-pyrogenicity .4
4.1.2 Biocompatibility .4
4.2 Physical characteristics .4
4.2.1 Blood pathway integrity .4
4.2.2 Heat exchanger fluid pathway integrity . .4
4.2.3 Blood volumes .4
4.2.4 Connectors .4
4.3 Performance characteristics .4
4.3.1 Oxygen and carbon dioxide transfer rates .4
4.3.2 Heat exchanger performance factor .5
4.3.3 Integral arterial filtration efficiency .5
4.3.4 Integral arterial filter flow rate capacity .5
4.3.5 Integral arterial filter air handling capability .5
4.3.6 Blood cell damage .5
4.3.7 Time-dependent performance changes .5
4.3.8 Shelf life .5
5 Tests and measurements to determine compliance with this document . 5
5.1 General .5
5.2 Biological characteristics .6
5.2.1 Sterility and non-pyrogenicity .6
5.2.2 Biocompatibility .6
5.3 Physical characteristics .6
5.3.1 Blood pathway integrity .6
5.3.2 Heat exchanger water pathway integrity.6
5.3.3 Blood volumes .7
5.3.4 Connectors .7
5.4 Performance characteristics .7
5.4.1 Oxygen and carbon dioxide transfer rates .7
5.4.2 Heat exchanger performance factor .8
5.4.3 Blood cell damage .8
5.4.4 Shelf life .9
5.4.5 Filtration efficiency.9
5.4.6 Integral arterial filter flow rate .9
5.4.7 Air-handling capability of integral arterial filter .9
6 Information supplied by the manufacturer .11
6.1 Information on the oxygenator .11
6.2 Information on the packaging.11
6.2.1 Unit container .11
6.2.2 Shipping con
...

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