EN ISO 7199:2014

SLOVENSKI STANDARD
01-oktober-2014
1DGRPHãþD
SIST EN 12022:2000
Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov
(ISO 7199:2009 + Amd 1:2012)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO
7199:2009 + Amd 1:2012)
Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren)
(ISO 7199:2009 + Amd 1:2012)
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels
(oxygénateurs) (ISO 7199:2009 + Amd 1:2012)
Ta slovenski standard je istoveten z: EN ISO 7199:2014
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.

EUROPEAN STANDARD
EN ISO 7199
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2014
ICS 11.040.40 Supersedes EN 12022:1999
English Version
Cardiovascular implants and artificial organs - Blood-gas
exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
Implants cardiovasculaires et organes artificiels - Kardiovaskuläre Implantate und künstliche Organe -
Échangeurs gaz/sang extracorporels (oxygénateurs) (ISO Blutgasaustauscher (Oxygenatoren) (ISO 7199:2009 + Amd
7199:2009 + Amd 1:2012) 1:2012)
This European Standard was approved by CEN on 17 July 2014.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7199:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
Foreword
The text of ISO 7199:2009 + Amd 1:2012 has been prepared by Technical Committee ISO/TC 150 “Implants
for surgery” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 7199:2014 by 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 February 2015, and conflicting national standards shall be withdrawn
at the latest by February 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12022:1999.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7199:2009 + Amd 1:2012 has been approved by CEN as EN ISO 7199:2014 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Clause(s)/sub-clause(s) Essential Requirements (ERs) of
Qualifying remarks/Notes
of this EN Directive 93/42/EEC
4.1.1; 4.1.2; 5.2; 6.2.1; 6.2.2; 6.3 7.2 Some redundancies, but all
these EN sections address
performance and sterility
issues.
4.3.3; 5.2; 5.4.3 7.3
4.2.1; 4.2.2; 4.2.4 7.5
4.1.1; 6.2.1; 6.2.2; 6.3 8.1
6.2.1; 6.2.2; 6.3 8.3
6.2.1; 6.2.2; 6.3 8.4
4.1.1; 5.2.1; 6.2.1; 6.2.2; 6.2.3 8.5
6.2.1 8.6
6.1; 6.2.1 8.7
4.2.4 9.1
6.1; 6.2; 6.3 13
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 7199
Second edition
2009-04-15
Cardiovascular implants and artificial
organs — Blood-gas exchangers
(oxygenators)
Implants cardiovasculaires et organes artificiels — Échangeurs
gaz/sang extracorporels (oxygénateurs)

Reference number
ISO 7199:2009(E)
©
ISO 2009
ISO 7199:2009(E)
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ii © ISO 2009 – All rights reserved

ISO 7199:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Requirements . 3
4.1 Biological characteristics . 3
4.2 Physical characteristics. 3
4.3 Performance characteristics . 3
5 Tests and measurements to determine compliance with this International Standard. 4
5.1 General. 4
5.2 Biological characteristics . 4
5.3 Physical characteristics. 5
5.4 Performance characteristics . 5
6 Information supplied by the manufacturer .8
6.1 Information to be given on the oxygenator. 8
6.2 Information to be given on the packaging . 8
6.3 Information to be given in the accompanying documents. 9
6.4 Information to be given in the accompanying documents in a prominent form. 10
7 Packaging . 10
Bibliography . 11

ISO 7199:2009(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 7199 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 7199:1996), which has been technically revised.

iv © ISO 2009 – All rights reserved

ISO 7199:2009(E)
Introduction
This International Standard 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 labeling the device.
This International Standard therefore contains procedures to be used for evaluation of extracorporeal blood-
gas exchangers (oxygenators). Type test procedures for determination of 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 will suit the needs of the patient.
This International Standard also includes minimum reporting requirements, which will allow the user to
compare performance characteristics of oxygenators of different designs in a standard way.
This International Standard makes reference to other International Standards in which methods for
determination of characteristics common to medical devices can be found.
No provisions have been made for quantification of microbubble generation or for 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 International Standard. Such
studies may be parts of a manufacturer's quality system.
This International Standard contains only those requirements that are specific to oxygenators. Non-specific
requirements are covered by references to other International Standards listed in the normative references
section. Since non-toxicity is anticipated to be the subject of a future horizontal/level 1 standard, this
International Standard does not cover non-toxicity.

INTERNATIONAL STANDARD ISO 7199:2009(E)

Cardiovascular implants and artificial organs — Blood-gas
exchangers (oxygenators)
1 Scope
This International Standard 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.
This International Standard also applies to heat exchangers that are integral parts of oxygenators and to external
equipment unique to the use of the device.
This International Standard does not apply to:
⎯ implanted oxygenators;
⎯ liquid oxygenators;
⎯ extracorporeal circuits (blood tubing);
⎯ separate heat exchangers;
⎯ separate ancillary devices.
2 Normative references
The following referenced documents are indispensable for the application 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
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 11135:1994, Medical devices — Validation and routine control of ethylene oxide sterilization
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 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 7199:2009(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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
paths of the oxygenator containing blood during intended clinical use
3.3
gas pathway
parts of the oxygenator 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 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 and the temperature of blood at the inlet of the oxygenator
3.6
integral part
part that is connected to the oxygenator and cannot normally be separated by the user
3.7
operating variables
settings of controls that affect the function of the device
3.8
platelet reduction
percentage reduction of platelets contained in a circuit incorporating an oxygenator, less the percentage
reduction in an identical control circuit without an oxygenator, as a function of time
3.9
plasma-free haemoglobin level
concentration of plasma-free haemoglobin in a circuit incorporating an oxygenator, less the concentration in
an identical control circuit without an oxygenator, as a function of time
3.10
white blood cell reduction
percentage reduction of white blood cells contained in a circuit incorporating an oxygenator, less the
percentage reduction in an identical control circuit without an oxygenator, as a function of time
3.11
residual blood volume
difference between the priming volume of the unit and the blood volume that can be e
...