Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)

DOW = DAV + 36 months

Kardiovaskuläre Implantate und künstliche Organe - Blut-Gas-Austauscher (Oxygenatoren) - Änderung 1: Anschlüsse (ISO 7199:2016/Amd 1:2020)

-No scope available-

Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels (oxygénateurs) - Amendement 1 (ISO 7199:2016/Amd 1:2020)

Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov (oksigenatorji) - Dopolnilo A1: Konektorji (ISO 7199:2016/Amd 1:2020)

General Information

Status
Published
Public Enquiry End Date
24-Jul-2018
Publication Date
23-Apr-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
09-Apr-2020
Due Date
14-Jun-2020
Completion Date
24-Apr-2020

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SLOVENSKI STANDARD
SIST EN ISO 7199:2017/A1:2020
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
SIST EN ISO 7199:2017/A1:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 7199:2017/A1:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 7199:2017/A1:2020
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.
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SIST EN ISO 7199:2017/A1:2020
EN ISO 7199:2017/A1:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 7199:2017/A1:2020
EN ISO 7199:2017/A1:2020 (E)
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.
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SIST EN ISO 7199:2017/A1:2020
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SIST EN ISO 7199:2017/A1:2020
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
---------------------- Page: 7 ----------------------
SIST EN ISO 7199:2017/A1:2020
ISO 7199:2016/Amd.1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 7199:2017/A1:2020
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 2020 – All rights reserved iii
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SIST EN ISO 7199:2017/A1:2020
---------------------- Page: 10 ----------------------
SIST EN ISO 7199:2017/A1:2020
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
...

SLOVENSKI STANDARD
SIST EN ISO 7199:2017/oprA1:2018
01-julij-2018

Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov

(oksigenatorji) - Dopolnilo A1: Konektorji (ISO 7199:2016/DAM 1:2018)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) -

Amendment 1: Connectors (ISO 7199:2016/DAM 1:2018)

Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren)

- Änderung 1 (ISO 7199:2016/DAM 1:2018)

Implants cardiovasculaires et organes artificiels - Échangeurs gaz/sang extracorporels

(oxygénateurs) - Amendement 1 (ISO 7199:2016/DAM 1:2018)
Ta slovenski standard je istoveten z: EN ISO 7199:2017/prA1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 7199:2017/oprA1:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 7199:2017/oprA1:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 7199:2017/oprA1:2018
DRAFT AMENDMENT
ISO 7199:2016/DAM 1
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-05-14 2018-08-06
Cardiovascular implants and artificial organs — Blood-gas
exchangers (oxygenators)
AMENDMENT 1: Connectors

Implants cardiovasculaires et organes artificiels — Échangeurs gaz/sang extracorporels (oxygénateurs)

AMENDEMENT 1: .
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 7199:2016/DAM 1:2018(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 2018
---------------------- Page: 3 ----------------------
SIST EN ISO 7199:2017/oprA1:2018
ISO 7199:2016/DAM 1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
---------------------- Page: 4 ----------------------
SIST EN ISO 7199:2017/oprA1:2018
ISO 7199:2016/DAM 1:2018(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.

Amendment 1 to ISO 7199:2017 was prepared by Technical Committee ISO/TC 150, Implants for surgery,

Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.
© ISO 2018 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST EN ISO 7199:2017/oprA1:2018
---------------------- Page: 6 ----------------------
SIST EN ISO 7199:2017/oprA1:2018
ISO 7199:2016/DAM 1:2018(E)
Cardiovascular implants and artificial organs — Blood-gas
exchangers (oxygenators)
AMENDMENT 1: Connectors
Modify 4.2.4 Connectors to read:
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 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, or 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 the informative Annex A (formerly defined by ISO 594-1/-2)

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, Clause 6, using the

reference fittings given in Annex A.
Connectors for the heat exchanger fluid pathway shall
...

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