EN ISO 8637-2:2024
(Main)Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blut- und Flüssigkeitskreislauf bei Hämodialysatoren, Hämodiafiltern, Hämofiltern und Hämokonzentratoren (ISO 8637‑2:2024)
Dieses Dokument legt Anforderungen an extrakorporale Blut- und Flüssigkeitskreisläufe und Zubehör für den einmaligen Gebrauch fest, die in Kombination mit Hämodialysegeräten für extrakorporale Blutbehandlungstherapien wie z. B. Hämodialyse, Hämodiafiltration und Hämofiltration verwendet werden, jedoch nicht darauf beschränkt sind.
Dieses Dokument gilt nicht für:
Hämodialysatoren, Hämodiafilter oder Hämofilter;
Plasmafilter;
Hämoperfusionsgeräte;
Geräte für den vaskulären Zugang.
ANMERKUNG 1 Die Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren sind in ISO 8637 1 spezifiziert.
ANMERKUNG 2 Die Anforderungen an Plasmafilter sind in ISO 8637 3 spezifiziert.
Systèmes extracorporels pour la purification du sang - Partie 2: Circuits sanguins extracorporels et liquidiens pour les hémodialyseurs, les hémodiafiltres, les hémofiltres et les hémoconcentrateurs (ISO 8637-2:2024)
Le présent document spécifie les exigences relatives aux circuits sanguins extracorporels et liquidiens jetables et aux accessoires utilisés conjointement avec un appareil d’hémodialyse destiné aux thérapies avec traitement du sang extracorporel, notamment, entre autres, l’hémodialyse, l’hémodiafiltration et l’hémofiltration.
Le présent document ne s’applique pas aux:
— hémodialyseurs, hémodiafiltres ou hémofiltres;
— filtres pour plasma;
— dispositifs d’hémoperfusion;
— dispositifs d’accès vasculaire.
NOTE 1 Les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs sont spécifiées dans l’ISO 8637-1.
NOTE 2 Les exigences relatives aux filtres pour plasma sont spécifiées dans l’ISO 8637-3.
Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni in tekočinski obtok za hemodializatorje, hemodiafiltre, hemofiltre in hemokoncentratorje (ISO 8637-2:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8637-2:2024
01-junij-2024
Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni in
tekočinski obtok za hemodializatorje, hemodiafiltre, hemofiltre in
hemokoncentratorje (ISO 8637-2:2024)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid
circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO
8637-2:2024)
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blut- und
Flüssigkeitskreislauf bei Hämodialysatoren, Hämodiafiltern, Hämofiltern und
Hämokonzentratoren (ISO 8637-2:2024)
Systèmes extracorporels pour la purification du sang - Partie 2: Circuits sanguins
extracorporels et liquidiens pour les hémodialyseurs, les hémodiafiltres, les hémofiltres
et les hémoconcentrateurs (ISO 8637-2:2024)
Ta slovenski standard je istoveten z: EN ISO 8637-2:2024
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8637-2:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8637-2:2024
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SIST EN ISO 8637-2:2024
EN ISO 8637-2
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8637-2:2018
English Version
Extracorporeal systems for blood purification - Part 2:
Extracorporeal blood and fluid circuits for haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators
(ISO 8637-2:2024)
Systèmes extracorporels pour la purification du sang - Extrakorporale Systeme zur Blutreinigung - Teil 2:
Partie 2: Circuits sanguins extracorporels et liquidiens Extrakorporaler Blut- und Flüssigkeitskreislauf bei
pour les hémodialyseurs, les hémodiafiltres, les Hämodialysatoren, Hämodiafiltern, Hämofiltern und
hémofiltres et les hémoconcentrateurs (ISO 8637- Hämokonzentratoren (ISO 8637-2:2024)
2:2024)
This European Standard was approved by CEN on 15 December 2023.
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, 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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8637-2:2024 E
worldwide for CEN national Members.
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SIST EN ISO 8637-2:2024
EN ISO 8637-2:2024 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 8637-2:2024
EN ISO 8637-2:2024 (E)
European foreword
This document (EN ISO 8637-2:2024) 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 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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.
This document supersedes EN ISO 8637-2:2018.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations
...
SLOVENSKI STANDARD
oSIST prEN ISO 8637-2:2023
01-januar-2023
Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni in
tekočinski obtok za hemodializatorje, hemodiafiltre, hemofiltre in
hemokoncentratorje (ISO/DIS 8637-2:2022)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid
circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
(ISO/DIS 8637-2:2022)
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei
Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO/DIS 8637-2:2022)
Systèmes extracorporels pour la purification du sang - Partie 2: Circuits sanguins
extracorporels et liquidiens pour les hémodialyseurs, les hémodiafiltres, les hémofiltres
et les hémoconcentrateurs (ISO/DIS 8637-2:2022)
Ta slovenski standard je istoveten z: prEN ISO 8637-2
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8637-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 8637-2:2023
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oSIST prEN ISO 8637-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8637-2
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-10-24 2023-01-16
Extracorporeal systems for blood purification —
Part 2:
Extracorporeal blood and fluid circuits for haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 2: Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
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ISO/DIS 8637-2:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 8637-2:2023
ISO/DIS 8637-2:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8637-2
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
Extracorporeal systems for blood purification —
Part 2:
Extracorporeal blood and fluid circuits for haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 2: Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 8637-2:2023
ISO/DIS 8637-2:2022(E)
Contents Page
Foreword .
...
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