SIST EN ISO 7199:2017

SLOVENSKI STANDARD
SIST EN ISO 7199:2017
01-april-2017
1DGRPHãþD
SIST EN ISO 7199:2014
Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov
(oksigenatorji) (ISO 7199:2016)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO
7199:2016)
Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren)
(ISO 7199:2016)
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels
(oxygénateurs) (ISO 7199:2016)
Ta slovenski standard je istoveten z: EN ISO 7199:2017
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 7199:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7199:2017

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SIST EN ISO 7199:2017


EN ISO 7199
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2017
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 7199:2014
English Version

Cardiovascular implants and artificial organs - Blood-gas
exchangers (oxygenators) (ISO 7199:2016)
Implants cardiovasculaires et organes artificiels - Kardiovaskuläre Implantate und künstliche Organe -
Échangeurs gaz/sang extracorporels (oxygénateurs) Blutgasaustauscher (Oxygenatoren) (ISO 7199:2016)
(ISO 7199:2016)
This European Standard was approved by CEN on 6 November 2016.

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, Serbia, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7199:2017 E
worldwide for CEN national Members.

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SIST EN ISO 7199:2017
EN ISO 7199:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered. 5

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SIST EN ISO 7199:2017
EN ISO 7199:2017 (E)
European foreword
This document (EN ISO 7199:2017) 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 July 2017, and conflicting national standards shall be
withdrawn at the latest by July 2017.
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 ISO 7199:2014.
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.
For relationship with EU Directive, 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard "within the
meaning of Annex ZA", the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
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SIST EN ISO 7199:2017
EN ISO 7199:2017 (E)
Table — Correlations between undated normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of
EN ISO
the ISO standard
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 and
Amd 1:2006
ISO 10993-7 EN ISO 10993-7:2008 and ISO 10993-7:2008 and
EN ISO 10993-7:2008/AC:2009 ISO 10993-7:1/Cor 1:2009
ISO 10993-11 EN ISO 10993-11:2009 ISO 10993-11:2006
ISO 11135 EN ISO 11135:2014 ISO 11135:2014
ISO 11137-1 EN ISO 11137-1:2006 and ISO 11137-1:2006 and
EN ISO 11137-1:2006/A1:2013 Amd 1:2013
ISO 11607-1 EN ISO 11607-1:2009 and ISO 11607-1:2006 and
EN ISO 11607-1:2009/A1:2014 Amd 1:2014
ISO 11607-2 EN ISO 11607-2:2006 and ISO 11607-2:2006 and
EN ISO 11607-2:2006/A1:2014 Amd 1:2014
ISO 15675 — ISO 15675:2009
ISO 17665-1 EN ISO 17665-1:2006 ISO 17665-1:2006
Endorsement notice
The text of ISO 7199:2016 has been approved by CEN as EN ISO 7199:2017 without any modification.
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SIST EN ISO 7199:2017
EN ISO 7199:2017 (E)
Annex ZA
(informative)

Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission's standardization request ‘M/023
concerning the development of European standards related to medical devices’ to provide a voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made,
the risk management process needs to be in compliance with Directive 93/42/EEC as amended by
2007/47/EC. This means that risks have to be reduced "as far as possible", "to a minimum", "to the
lowest possible level", "minimized" or "removed", according to the wording of the corresponding
essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Directive 93/42/EEC [OJ L 169]
Essential Requirements
Clause(s)/sub-clause(s) of
(ERs) of Directive Remarks/Notes
this EN
93/42/EEC
7.2 4.1.1; 4.1.2; 5.2; 5.2.1; 5.2.2; 4.1.1 and 4.1.2 address
5.3; 5.3.1; 5.3.1.1; 5.3.1.2; manufacturers’ requirements
5.3.2; 5.3.2.1; 5.3.2.2; 6.2.1 d); to ensure product sterility,
6.2.2 d); 6.3 u) 1) non-pyrogenicity, and
biocompatibility. 5.2 and 5.3
with associated sub-clauses
address testing for the above
to verify compliance that
products are sterile, non-
pyrogenic, and biocompatible.
6.2.1, 6.2.2 and 6.3 with
associated sub-clauses
address labelling to include
the manufacturers’
documentation attesting to
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SIST EN ISO 7199:2017
EN ISO 7199:2017 (E)
the above, which are to be
supplied on the unit
container, shipping container,
and accompanying product
literature, including
«Instructions for Use».
7.3 4.3.6; 4.3.6.1; 4.3.6.2; 5.2; 4.3.6 with associated sub-
5.2.1; 5.2.2; 5.4.3; 5.4.3.1; clauses address blood cell
5.4.3.2 damage when the product is
used for its intended purpose.
5.2 with associated sub-
clauses address biological
characteristics and
manufacturers’ compliance
for verification regarding
sterility, non-pyrogenicity and
biocompatibility. 5.4.3 with
associated sub-clauses
describe specific testing
parameters for documenting
blood cell damage.
The second part of ER 7.3
relating to medicinal products
is not covered.
7.5 4.2.1; 4.2.2; 4.2.4 4.2.1 and 4.2.2 address
minimizing the risk of leakage
by the requirement that blood
pathways (e.g. oxygenator,
heat exchanger) do not leak.
4.2.4 addresses the
requirement that connectors
used for connections to the
blood pathways must be
secure, which also addresses
the minimization of risk of
leakage.
Only the first sentence of ER
7.5 is covered.
8.1 4.1.1; 4.1.2; 6.2.1 d); 6.2.2 d); 4.1.1 and 4.1.2 require
6.3 u) 1) products to be sterile, non-
pyrogenetic, and
biocompatible. 6.2.1, 6.2.2,
and 6.3 with associated sub-
clauses address sterilization
information to be supplied on
labelling for the units,
shipping containers, and in
the accompanying
«Instructions for Use».
Only the first sentence of ER
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SIST EN ISO 7199:2017
EN ISO 7199:2017 (E)
8.1 is covered.
9.1 4.2.4 4.2.4 addresses
manufacturers‘ requirements
that connectors provide for
secure connection of
additional products for
assembly into a system for its
intended use.
4.2.4 covers ER 9.1 in respect
of blood pathway connections
only.
13.1 6.1 a); 6.2.1 a) h); 6.2.2 a); 6.3 6.1, 6.2 and 6.3 with
a) associated sub-clauses
address the manufacturers’
identification, «Instructions
for Use» for the safe use of the
product and any special
handling or storage
conditions.
13.1, first paragraph, last five
words only are covered by 6.1
a), 6.2.1 a), 6.2.2 a) and 6.3 a)
only.
13.2 6.2.1 g) i) Clause 6.2.1 with associated
sub-clauses address use of
approved symbols on the unit
container.
13.2 is covered only is respect
of 'Read Instructions for use'
and 'Single use only'.
13.3 a) 6.2.1 a), 6.2.2 a) and 6.3 a) The standard does not
address a requirement
regarding an authorised
representative when the
manufacturer does not have a
registered place of business in
the Community.
ER 13.3 a) is covered by 6.2.1
a), 6.2.2 a) and 6.3 a) but only
in respect of manufacturer.
13.3 b) 6.2.1 b)-c); 6.2.2 b)-c); 6.3 b) 6.2.1, 6.2.2 and 6.3 with
associated sub-clauses
address identification of the
device and contents of the
packaging.
13.3 c) 6.2.1 d); 6.2.2 d) 6.2.1 and 6.2.2 with
associated sub-clauses
address designation of the
sterility of the product on the
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SIST EN ISO 7199:2017
EN ISO 7199:2017 (E)
unit and shipping containers
and in the «Instructions for
Use».
13.3 d) 6.2.1 f) 6.2.1 with the associated sub-
clause address product batch,
lot or serial number
designations.
ER 13.3 d) is only met if the
batch code is preceded by the
word 'LOT'.
13.3 e) 6.2.2 e) 6.2.2 with the associated sub-
clause address expiry date on
the unit container.
ER 13.3 e) is only met if the
expiry date is given as a year
and month.
13.3 f) 6.2.1 i) 6.2.1 with the associated sub-
clause address one-time
(single) use of the device.
13.3 i) 6.2.1 h); 6.2.2 f) 6.2.1 and 6.2.2 with
associated sub-clauses
address labelling on the unit
and shipping containers
regarding any special
handling or storage
conditions.
13.3 j) 6.3 d) 6.3 and 6.4 with associated
sub-clauses address special or
unique procedures and
limitations during use in
accompanying documents.
ER 13.3 j) is covered by 6.3 d)
only in respect of the
„Instructions for Use».
13.3 k) 6.2.1 g) 6.2.1 with the associated sub-
clause address «Instructions
for Use» containing warnings
and precautions.
ER 13.3 k) is covered by 6.2.1
g) only in respect of the unit
container.
13.4 6.2.1 g); 6.3 6.2.1 with the associated sub-
clause and 6.3 address
«Instructions for Use»
labelling on the unit container
and in accompanying
documents supplied with the
product.
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SIST EN ISO 7199:2017
EN ISO 7199:2017 (E)
13.6 c) 6.3 e)-g) 6.3 with associated sub-
clauses address mounting and
connection of device
components for safe use.
ER 13.6 c) is covered only to
the extent shown in 6.3 e)-g).
13.6 i) 6.3 e) f) The standard addresses
sterile products that do not
require further treatment
before use. 6.3 with
associated sub-clauses
address mounting of the
device and assembly with
other products before use.
ER 13.6 i) is covered only to
the extent shown in 6.3 e)-f).
13.6 p) 4.2.3 4.2.3 addresses testing of
volumetric measurements
and tolerances specified by
the manufacturer.
ER 13.6 p) is only covered for
blood volumes only and only
when the degree of accuracy
is given in the „Instructions
for Use».
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.

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SIST EN ISO 7199:2017

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SIST EN ISO 7199:2017
INTERNATIONAL ISO
STANDARD 7199
Third edition
2016-11-15
Cardiovascular implants and artificial
organs — Blood-gas exchangers
(oxygenators)
Implants cardiovasculaires et organes artificiels — Échangeurs gaz/
sang extracorporels (oxygénateurs)
Reference number
ISO 7199:2016(E)
©
ISO 2016

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SIST EN ISO 7199:2017
ISO 7199:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

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SIST EN ISO 7199:2017
ISO 7199:2016(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
4.1.1 Sterility and non-pyrogenicity . 3
4.1.2 Biocompatibility . 3
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 . 4
4.3.3 Integral arterial filtration efficiency. 4
4.3.4 Integral arterial filter flow rate capacity . 4
4.3.5 Integral arterial filter air handling capability . 4
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 . 5
5.2.1 Sterility and non-pyrogenicity . 5
5.2.2 Biocompatibility . 5
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 . 6
5.3.4 Connectors . 6
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 . 8
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 .10
6.1 Information on the oxygenator .10
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 .11
6.4 Information in the accompanying documents in a prominent form .12
7 Packaging .12
Bibliography .13
© ISO 2016 – All rights reserved iii

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SIST EN ISO 7199:2017
ISO 7199:2016(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.
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 documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following URL: http://www.iso.org/iso/
foreword.html
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This third edition cancels and replaces the second edition (ISO 7199:2009), which has been technically
revised.
It also incorporates the Amendment ISO 7199:2009/Amd.1:2012.
iv © ISO 2016 – All rights reserved

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SIST EN ISO 7199:2017
ISO 7199:2016(E)

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 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 document also includes minimum reporting requirements, which will 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 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 document. Such studies
may be parts of a manufacturer’s quality system.
This document contains only those requirements that are specific to oxygenators. Non-spec
...