EN ISO 8637-2:2018

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.
This document does not apply to:
—          haemodialysers, haemodiafilters or haemofilters;
—          plasmafilters;
—          haemoperfusion devices;
—          vascular access devices;
—          blood pumps;
—          pressure monitors for the extracorporeal blood circuit;
—          air detection devices;
—          systems to prepare, maintain or monitor dialysis fluid;
—          systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE 1    Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3.
NOTE 2    Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8637-2:2018)

WARNUNG - Für Produkte, die unter den Anwendungsbereich dieses Dokuments fallen, können andere Anforderungen und andere EU-Richtlinien anwendbar sein.
Dieses Dokument spezifiziert die Anforderungen an den Blutkreislauf für Geräte, die in extrakorporalen Blutfiltrationstherapien wie Hämodialyse, Hämodiafiltration, Hämofiltration, Schutzvorrichtungen für Messwandler (integral und nicht integral) oder ähnlichen Verfahren verwendet werden und die für den Gebrauch in derartigen Kreisläufen vorgesehen sind.
Dieses Dokument gilt nicht für
- Hämodialysatoren, Hämodiafilter, Hämofilter,
- Plasmafilter,
- Hämoperfusionsgeräte,
- Geräte für den vaskulären Zugang,
- Blutpumpen,
- Druckaufzeichnungsgeräte für extrakorporale Blutkreisläufe,
- Luftnachweisgeräte,
- Systeme für die Herstellung, Aufbewahrung oder Überwachung der Dialyseflüssigkeit,
- Systeme oder Vorrichtungen für die Durchführung von Hämodialyse, Hämodiafiltration, Hämofiltration oder Hämokonzentration.
ANMERKUNG 1 Die Anforderungen an Hämodialysatoren, Hämodiafilter Hämofilter und Hämokonzentratoren sind in ISO 8637-1 spezifiziert, und Anforderungen an Plasmafilter sind in ISO 8637-3 spezifiziert.
ANMERKUNG 2 Extrakorporale Blutschlauchsets können auch für andere extrakorporale Therapien wie Hämoperfusion, Plasmafiltration und Plasmaadsorption verwendet werden.

Systèmes extracorporels pour la purification du sang - Partie 2: Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8637-2:2018)

Le présent document spécifie les exigences relatives au circuit sanguin des dispositifs utilisés dans le cadre de thérapies avec filtration du sang extracorporelle, notamment, entre autres, pour l'hémodialyse, l'hémodiafiltration et l'hémofiltration, et pour les protecteurs de transducteur (intégrés et non intégrés) destinés à être utilisés dans de tels circuits.
Le présent document ne s'applique pas aux:
—          hémodialyseurs, hémodiafiltres ou hémofiltres;
—          filtres pour plasma;
—          dispositifs d'hémoperfusion;
—          dispositifs d'accès vasculaire;
—          pompes sanguines;
—          moniteurs de pression du circuit sanguin extracorporel;
—          dispositifs de détection d'air;
—          systèmes de préparation, de conservation ou de contrôle du liquide de dialyse;
—          systèmes ou à l'équipement destinés à effectuer une hémodialyse, une hémodiafiltration, une hémofiltration ou une hémoconcentration.
NOTE 1    Les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs sont spécifiées dans l'ISO 8637‑1, et les exigences concernant les filtres pour plasma sont indiquées dans l'ISO 8637‑3.
NOTE 2    Des tubulures de transfusion extracorporelles peuvent également être utilisées pour d'autres thérapies extracorporelles telles que l'hémoperfusion, la plasmafiltration et l'adsorption de plasma.

Zunajtelesni pretočni sistemi za čiščenje krvi - 2. del: Zunajtelesni krvni obtok za hemodializatorje, hemodiafiltre in hemofiltre (ISO 8637-2:2018)

OPOZORILO: Za proizvode, ki sodijo na področje uporabe tega dokumenta, lahko veljajo tudi druge zahteve in druge direktive EU.
Ta dokument določa zahteve za krvni obtok za pripomočke, ki se uporabljajo pri zdravljenjih z zunajtelesnimi pretočnimi sistemi za čiščenje krvi, ki med drugim vključujejo hemodializo, hemodiafiltracijo, hemofiltracijo in pretvorniška varovala (integrirana in neintegrirana), ki se uporabljajo v takšnih obtokih.
Ta dokument se ne uporablja za:
– hemodializatorje, hemodiafiltre in hemofiltre;
– plazmafiltre;
– hemoperfuzijske pripomočke;
– žilne dostopovne pripomočke;
– črpalke krvi;
– monitorje tlaka za zunajtelesni obtok;
– pripomočke za zaznavanje prisotnosti zraka;
– sisteme za pripravo, ohranjanje in spremljanje dializne tekočine;
– sisteme ali opremo za izvajanje hemodialize, hemodiafiltracije, hemofiltracije ali hemokoncentracije.
OPOMBA 1: Zahteve za hemodializatorje, hemodiafiltre, hemofiltre in hemokoncentratorje so podane v standardu ISO 8637-1, zahteve za plazmafiltre pa v standardu ISO 8637-3.
OPOMBA 2: Sklopi cevk za zunajtelesni obtok se lahko uporabljajo za druga zunajtelesna zdravljenja, kot so hemoperfuzija ter filtracija in absorpcija plazme.

General Information

• Status: Withdrawn
• Publication Date: 21-Aug-2018
• Withdrawal Date: 16-Apr-2024
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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: 22-Aug-2018
• Completion Date: 22-Aug-2018
• 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 8637-2:2018 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

Relations

• Replaces: EN ISO 8638:2014 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
• Effective Date: 02-Mar-2016
• Replaced By: EN 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)
• Effective Date: 25-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8637-2:2018
01-december-2018
1DGRPHãþD
SIST EN ISO 8638:2014
=XQDMWHOHVQLSUHWRþQLVLVWHPL]DþLãþHQMHNUYLGHO=XQDMWHOHVQLNUYQLREWRN]D
KHPRGLDOL]DWRUMHKHPRGLDILOWUHLQKHPRILOWUH,62
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei
Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8637-2:2018)
Systèmes extracorporels pour la purification du sang - Partie 2: Circuit sanguin
extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8637-
2:2018)
Ta slovenski standard je istoveten z: EN ISO 8637-2:2018
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8637-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8637-2:2018

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SIST EN ISO 8637-2:2018


EN ISO 8637-2
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2018
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 8638:2014
English Version

Extracorporeal systems for blood purification - Part 2:
Extracorporeal blood circuit for haemodialysers,
haemodiafilters and haemofilters (ISO 8637-2:2018)
Systèmes extracorporels pour la purification du sang - Kardiovaskuläre Implantate und extrakorporale
Partie 2: Circuit sanguin extracorporel pour les Système - Teil 2: Extrakorporaler Blutkreislauf bei
hémodialyseurs, les hémodiafiltres et les hémofiltres Hämodialysatoren, Hämodiafiltern und Hämofiltern
(ISO 8637-2:2018) (ISO 8637-2:2018)
This European Standard was approved by CEN on 17 June 2018.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 26 September 2018.

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 NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8637-2:2018 E
worldwide for CEN national Members.

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SIST EN ISO 8637-2:2018
EN ISO 8637-2:2018 (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 . 4
2

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SIST EN ISO 8637-2:2018
EN ISO 8637-2:2018 (E)
European foreword
This document (EN ISO 8637-2:2018) 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 February 2019, and conflicting national standards
shall be withdrawn at the latest by August 2021.
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 8638:2014.
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
...