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CEN

prEN ISO 7199

(Main)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023)

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/DIS 7199:2023)

Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang (oxygénateurs) (ISO/DIS 7199:2023)

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/DIS 7199:2023)

General Information

Status
Not Published
Publication Date
11-Nov-2024
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Start Date
06-Mar-2024
Completion Date
06-Mar-2024
Ref Project
oSIST prEN ISO 7199:2023 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023)

Relations

Revises
EN ISO 7199:2017 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
Effective Date
19-Jan-2023
Revises
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
23-Jun-2021

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SLOVENSKI STANDARD
oSIST prEN ISO 7199:2023
01-oktober-2023
Nadomešča:
SIST EN ISO 7199:2017
Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov
(oksigenatorji) (ISO/DIS 7199:2023)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
(ISO/DIS 7199:2023)
Kardiovaskuläre Implantate und künstliche Organe - Blut-Gas-Austauscher
(Oxygenatoren) (ISO/DIS 7199:2023)
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang (oxygénateurs)
(ISO/DIS 7199:2023)
Ta slovenski standard je istoveten z: prEN ISO 7199
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 7199:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 7199:2023

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oSIST prEN ISO 7199:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7199
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-07-19 2023-10-11
Cardiovascular implants and artificial organs — Blood-gas
exchangers (oxygenators)
Implants cardiovasculaires et organes artificiels — Échangeurs gaz/sang extracorporels (oxygénateurs)
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7199:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 3 ----------------------
oSIST prEN ISO 7199:2023
ISO/DIS 7199:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7199
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:

Cardiovascular implants and artificial organs — Blood-gas
exchangers (oxygenators)
Implants cardiovasculaires et organes artificiels — Échangeurs gaz/sang extracorporels (oxygénateurs)
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 7199:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 4 ----------------------
oSIST prEN ISO 7199:2023
ISO/DIS 7199:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references .
...

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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
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1.1 General
This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
1.2 Inclusions
This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:
a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;
c) the reprocessing of dialysers intended for single use where permitted for multiple uses,
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1.3 Exclusions
This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500‑5,
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