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EN ISO 7199:2017

(Main)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)

ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
-      implanted oxygenators,
-      liquid oxygenators,
-      extracorporeal circuits (blood tubing),
-      separate heat exchangers,
-      separate ancillary devices, and
-      separate arterial line filter.

Kardiovaskuläre Implantate und künstliche Organe - Blutgasaustauscher (Oxygenatoren) (ISO 7199:2016)

Dieses Dokument legt Anforderungen an sterile extrakorporale Blutgasaustauscher (Oxygenatoren) zum Einmalgebrauch fest, die zur Zufuhr von Sauerstoff in das und zur Entfernung von Kohlendioxid aus dem menschliche(n) Blut bestimmt sind.
Dieses Dokument gilt auch für Wärmeaustauscher und arterielle Filter, die in Oxygenatoren integriert sind.
Das vorliegende Dokument gilt auch für Außengeräte, die allein für den Gebrauch mit dem Gerät bestimmt sind.
Dieses Dokument gilt nicht für:
   implantierte Oxygenatoren;
   Flüssigkeits-Oxygenatoren;
   extrakorporale Kreisläufe (Blutschlauchsysteme);
   separate Wärmeaustauscher;
   separate Hilfsgeräte und
   separate arterielle Filterleitungen.

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

L'ISO 7199:2016 précise les prescriptions relatives aux échangeurs gaz/sang extracorporels stériles (oxygénateurs), à usage unique, destinés à oxygéner le sang des patients et à en éliminer le dioxyde de carbone.
L'ISO 7199:2016 s'applique également aux échangeurs thermiques et aux filtres artériels qui font partie intégrante des oxygénateurs.
Il s'applique aussi à l'équipement externe propre à l'utilisation de l'oxygénateur.
L'ISO 7199:2016 ne s'applique pas aux:
- oxygénateurs implantés,
- oxygénateurs liquides,
- circuits extracorporels (tubulures pour le sang),
- échangeurs thermiques non intégrés,
- dispositifs annexes distincts, et
- filtres de ligne artérielle distincts.

Vsadki (implantati) za srce in ožilje ter umetni organi - Izmenjevalniki krvnih plinov (oksigenatorji) (ISO 7199:2016)

Ta dokument določa zahteve za sterilne zunajtelesne izmenjevalnike krvnih plinov za enkratno uporabo, ki so namenjeni za dovajanje kisika in odvajanje ogljikovega dioksida iz človeške krvi.
Ta dokument se uporablja tudi za izmenjevalnike toplote in arterijske filtre, ki so sestavni deli
oksigenatorja.
Ta dokument se uporablja tudi za zunanjo opremo, edinstveno za uporabo oksigenatorja.
Ta dokument se ne uporablja za
– vsajene oksigenatorje,
– tekoče oksigenatorje,
– zunajtelesne obtoke (cevke za kri),
– ločene izmenjevalnike toplote,
– ločene pomožne pripomočke in
– ločene arterijske filtre.

General Information

Status
Published
Publication Date
24-Jan-2017
Withdrawal Date
30-Jul-2017
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
25-Jan-2017
Completion Date
25-Jan-2017
Directive
2006/42/EC - Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)
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 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)

Relations

Replaces
EN ISO 7199:2014 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
Effective Date
01-Feb-2017
Amended By
EN ISO 7199:2017/A1:2020 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/Amd 1:2020)
Effective Date
25-Oct-2017
Revised
prEN ISO 7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023)
Effective Date
19-Jan-2023

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Standards Content (Sample)

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.

---------------------- Page: 1 ----------------------

SIST EN ISO 7199:2017

---------------------- Page: 2 ----------------------

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.

---------------------- Page: 3 ----------------------

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

2

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

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
...

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ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
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1.1 General
This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
1.2 Inclusions
This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:
a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;
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d) the reprocessing of dialysers not specifically marked as intended for single use.
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