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

2019-11-11-JO:  CEN/TC 205 Decision 19/2019 on delinking EN ISO 7199:2017/prA1 from MDD.
DOW = DAV + 36 months

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

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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
Publication Date
31-Mar-2020
Withdrawal Date
30-Oct-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Apr-2020
Completion Date
01-Apr-2020

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Standards Content (Sample)

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.

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SIST EN ISO 7199:2017/A1:2020

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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

2

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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 m
...

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.

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SIST EN ISO 7199:2017/oprA1:2018

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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

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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

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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

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SIST EN ISO 7199:2017/oprA1:2018

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SIST EN ISO 7199:2017/oprA1:2018
ISO 7199:2016/DAM 1:2018(E)
Cardiovascular implants and artificia
...

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