SIST EN ISO 7199:2024

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 container .11
6.3 Information in the accompanying documents . 12
6.4 Information in the accompanying documents in a prominent form . 13
7 Packaging.13
Annex A (informative) Examples of connectors . 14
Bibliography .22

iii
ISO 7199:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC
2, Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 7199:2016), which has been technically
revised. It also incorporates the Amendment ISO 7199:2016/Amd.1:2020.
The main changes are as follows:
— circular definitions have been corrected for platelet reduction (3.10), plasma free haemoglobin (3.11)
and white blood cell reduction (3.12);
— the definition of priming volume (3.18) has been added;
— the sampling time point of 5 min has been deleted in Table 2.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 7199:2024(en)
Introduction
This document is intended to ensure that devices designed to affect the exchange of gases in support of,
or as a substitution for, the normal respiratory function of the lungs have been adequately tested for both
their safety and function, and that extracorporeal device characteristics are appropriately disclosed when
labelling the device.
This document therefore contains procedures to be used for the evaluation of extracorporeal blood-gas
exchangers (oxygenators). Type test procedures to determine the gas transfer, blood cell damage and heat
exchanger performance are described, although limits for these characteristics are not specified. Ready
identification of the performance characteristics should, however, assist the user in the selection of an
oxygenator that suits the needs of the patient.
This document also includes minimum reporting requirements that allow the user to compare performance
characteristics of oxygenators of different designs in a standard way.
This document makes reference to other International Standards in which methods for the determination of
characteristics common to medical devices can be found.
No provisions have been made for the quantification of microbubble generation or for the non-formed
elements of bovine blood because there currently is no consensus regarding satisfactorily reproducible test
methods.
Requirements for animal and clinical studies have not been included in this document.
This document contains only those requirements that are specific to oxygenators. Since non-toxicity is
anticipated to be the subject of a future horizontal/level 1 standard, this document does not cover non-
toxicity.
v
International Standard ISO 7199:2024(en)
Cardiovascular implants and artificial organs — Blood-gas
exchangers (oxygenators)
1 Scope
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 (ECCO R), 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming,
sealing and assembly processes
ISO 17665, Sterilization of health care products — Moist heat — Requirements for the development, validation
and routine control of a sterilization process for medical devices

ISO 7199:2024(en)
ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
blood-gas exchanger
oxygenator
extracorporeal device designed to supplement, or be a substitute for, the respiratory function of the lungs
3.2
blood pathway
portion of the oxygenator (3.1) containing blood during intended clinical use
3.3
gas pathway
portion of the oxygenator (3.1) containing the ventilation gas during intended clinical use
3.4
heat exchanger
component that is intended to control the temperature of the circulating blood or priming solution
3.5
heat exchanger performance factor
R
ratio of the difference between the temperature of blood at the outlet of the oxygenator (3.1) and the
temperature of blood at the inlet of the oxygenator to the difference between the temperature of the water
at the inlet of the heat exchanger (3.4) and the temperature of blood at the inlet of the oxygenator
3.6
integral arterial filter
component that is intended to filter particles such as blood clots, debris and gas emboli from the blood
3.7
filtration efficiency
ability of the filter to remove particles from the simulated blood suspension test fluid
Note 1 to entry: Filtration efficiency is expressed as a percentage.
3.8
integral part
part that is connected to the oxygenator (3.1) and cannot normally be separated by the user
3.9
operating variable
setting of controls that affects the function of the device
3.10
platelet reduction
decrease in platelet count in a circuit incorporating an oxygenator (3.1)
Note 1 to entry: Platelet reduction is expressed as a percentage.

ISO 7199:2024(en)
3.11
plasma free haemoglobin
haemoglobin that is released from the red blood cells to the plasma
3.11.1
normalized index of haemolysis
NIH
mass of plasma free haemoglobin (3.11) released after pumping 100 l of blood
100 − Hct
NIH = ΔfV·· ·
Hb
100 Qt·
where
Δf is the increase of plasma free haemoglobin concentration over the sampling time interval, in g/l;
Hb
V is the circuit volume, in l;
Q is the flow rate, in l/min;
Hct is the haematocrit, in %;
t is the sampling time interval, in min
Note 1 to entry: The normalized index of haemolysis is expressed in grams per hectolitre.
3.12
white blood cell reduction
decrease in white blood cell count in a circuit incorporating an oxygenator (3.1)
Note 1 to entry: White blood cell reduction is expressed as a percentage.
3.13
residual blood volume
difference between the priming volume of the unit and the blood volume that can be extracted
3.14
blood analogue
test solution which simulates certain blood characteristics relevant for testing, such as viscosity and salinity
3.15
subject device
device under test
3.16
comparator device
device similar to the subject device (3.15) that is a legally marketed device, recognized-to-be-safe and is used
for the same intended clinical use
3.17
worst-case condition
operating variable (3.9) within those specified by the manufacturer for intended clinical use which represents
the supposed worst-case device operation for the respective test
3.18
priming volume
amount of fluid needed to fill the blood path of the device

ISO 7199:2024(en)
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
The blood pathway shall be sterile and non-pyrogenic.
Compliance shall be verified in accordance with 5.2.1.
4.1.2 Biocompatibility
All parts of the blood pathway shall be biocompatible with respect to their intended use.
Compliance shall be verified in accordance with 5.2.2.
4.2 Physical characteristics
4.2.1 Blood pathway integrity
When tested in accordance with 5.3.1, the blood pathway shall not leak.
4.2.2 Heat exchanger fluid pathway integrity
When tested in accordance with 5.3.2, the heat exchanger fluid pathway shall not leak.
4.2.3 Blood volumes
When tested in accordance with 5.3.3, the volume of the blood pathway shall be within the tolerances
specified by the manufacturer (see 6.3).
4.2.4 Connectors
Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.4, allow a secure
connection.
When tested in accordance with 5.3.4, the gas inlet connection to the gas pathway shall not separate.
NOTE 1 Connectors of a type that allows connection of tubes with an inner diameter of 4,8 mm, 6,3 mm, 9,5 mm
or 12,7 mm, a type that complies with ISO 8637-1:2017, Figure 1, or a type that complies with ISO 80369-7:2021 have
been found satisfactory.
NOTE 2 Connectors with dimensions as given in Annex A and fitting to functional gauges and reference steel
fittings is a way to comply with this requirement.
Performance testing of the connectors shall be performed in accordance with ISO 80369-7:2021, Clause 6.
The reference fittings given in Annex A can be used in the performance testing of the connectors.
Connectors for the heat exchanger fluid pathway shall be capable of being connected to female fast couplings.
NOTE 3 Connectors corresponding to ISO 8637-1:2017, Figure 2 are considered as one way to comply with this
requirement.
4.3 Performance characteristics
4.3.1 Oxygen and carbon dioxide transfer rates
When determined in accordance with 5.4.1, the oxygen and carbon dioxide transfer rates shall be within the
range of values specified by the manufacturer (see 6.3).

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