SIST EN ISO 7199:2017/A1:2020

SLOVENSKI STANDARD
01-maj-2020
Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov
(oksigenatorji) - Dopolnilo A1: Konektorji (ISO 7199:2016/Amd 1:2020)
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) -
Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)
Kardiovaskuläre Implantate und künstliche Organe - Blut-Gas-Austauscher
(Oxygenatoren) - Änderung 1: Anschlüsse (ISO 7199:2016/Amd 1:2020)
Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels
(oxygénateurs) - Amendement 1 (ISO 7199:2016/Amd 1:2020)
Ta slovenski standard je istoveten z: EN ISO 7199:2017/A1:2020
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 7199:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2020
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Cardiovascular implants and artificial organs - Blood-gas
exchangers (oxygenators) - Amendment 1: Connectors
(ISO 7199:2016/Amd 1:2020)
Implants cardiovasculaires et organes artificiels - Kardiovaskuläre Implantate und künstliche Organe -
Échangeurs gaz/sang extracorporels (oxygénateurs) - Blut-Gas-Austauscher (Oxygenatoren) - Änderung 1:
Amendement 1 (ISO 7199:2016/Amd 1:2020) Anschlüsse (ISO 7199:2016/Amd 1:2020)
This amendment A1 modifies the European Standard EN ISO 7199:2017; it was approved by CEN on 4 March 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7199:2017/A1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7199:2017/A1:2020) 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 October 2020, and conflicting national standards shall
be withdrawn at the latest by October 2020.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 7199:2016/Amd 1:2020 has been approved by CEN as EN ISO 7199:2017/A1:2020
without any modification.
INTERNATIONAL ISO
STANDARD 7199
Third edition
2016-11-15
AMENDMENT 1
2020-03
Cardiovascular implants and artificial
organs — Blood-gas exchangers
(oxygenators)
AMENDMENT 1: Connectors
Implants cardiovasculaires et organes artificiels — Échangeurs gaz/
sang extracorporels (oxygénateurs)
AMENDEMENT 1: Raccords
Reference number
ISO 7199:2016/Amd.1:2020(E)
©
ISO 2020
ISO 7199:2016/Amd.1:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 7199:2016/Amd.1:2020(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 (see 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 (see 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 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.
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.
ISO 7199:2016/Amd.1:2020(E)
Cardiovascular implants and artificial organs — Blood-gas
exchangers (oxygenators)
AMENDMENT 1: Connectors
4.2.4  Connectors
Replace the text of 4.2.4 with the following text:
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 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
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 according to ISO 80369-7:2016, Clause 6. The
reference
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