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CEN

EN ISO 7199:2017/A1:2020

(Amendment)

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

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)

-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
Publication Date
31-Mar-2020
Withdrawal Date
30-Oct-2020
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Apr-2020
Completion Date
01-Apr-2020
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 7199:2017/A1:2020 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)

Relations

Amends
EN ISO 7199:2017 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
Effective Date
25-Oct-2017
Revised
prEN ISO 7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023)
Effective Date
23-Jun-2021

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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

---------------------- Page: 4 ----------------------
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
...

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1.2 Inclusions
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