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
• 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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
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 Directive(s).
For the relationship with EU Directive(s) 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, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8637-2:2018 has been approved by CEN as EN ISO 8637-2:2018 without any
modification.
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request M/023
concerning the development of European standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements (ERs) Clause(s)/sub-clause(s) of Qualifying remarks/Notes
of Directive 93/42/EEC this European Standard
7.1 4.1, 4.2, 4.3, 5.2, 5.3, 5.4

7.2 4.1, 4.2, 4.3, 5.2, 5.3, 5.4 Clauses 4.1 and 5.2, cover ER
7.2 in relation to Biological
safety only.
Clauses 4.2 and 5.3, cover ER
7.2 in relation to sterility only.
Clauses 4.3 and 5.4, cover ER
7.2 in relation to Non-
pyrogenenicity only.
7.3 Not applicable
7.4 Not applicable
7.5 5.2, 5.5 Clause 5.2, cover ER 7.5 in
relation to Biological safety
only.
Essential Requirements (ERs) Clause(s)/sub-clause(s) of Qualifying remarks/Notes
of Directive 93/42/EEC this European Standard
7.6 Not applicable
8.1 4.1, 4.2, 4.3, 5.2, 5.3, 5.4 Clauses 4.1 and 5.2, cover ER
8.1 in relation to Biological
safety only.
Clauses 4.2 and 5.3, cover ER
8.1 in relation to sterility only.
Clauses 4.3 and 5.4, cover ER
8.1 in relation to Non-
pyrogenenicity only.
8.2 Not applicable
8.3 6.2h
8.4 5.3,5.4
8.5 Not applicable
8.6 Not applicable
8.7 Not applicable
9.1 6.4 ER 9.1 is covered by clause
6.4, but only in respect of the
provision of the information
specified in the standard.
9.2 Not applicable
9.3 Not applicable
10 Not applicable
11 Not applicable
12 Not applicable
13.1 6.1, 6.2, 6.3,6.4 ER 13.1 is covered by
standard clause 6.1, but only
in respect of the labelling on
the device and only in respect
of:
- The red and blue markings
at patient connection ends;
- The level markings for the
air-capture chamber – if
appropriate.
ER 13.1 is covered by clause
6.2, but only in respect of the
labelling on the unit container
and only in respect of the
information specified in the
standard
ER 13.1 is covered by clause
6.3, but only in respect of the
Essential Requirements (ERs) Clause(s)/sub-clause(s) of Qualifying remarks/Notes
of Directive 93/42/EEC this European Standard
labelling on the outer
container and only in respect
of the information specified in
the standard
13.2 6.1c to i, 6.2,6.3,6.4
13.3a 6.2a Clause 6.2a, ER 13.3a in
respect of the manufacturer
only, and only in respect of
the labelling on the unit
container.
13.3b 6.2b, 6.2c, 6.2d, 6.2k Clauses 6.2a, 6.2b, 6.2c and
6.2k cover ER 13.3b in respect
of the labelling on the unit
container.
13.3c 6.2e Clause 6.2e covers ER 13.3c in
respect of the labelling on the
unit container only.
13.3d 6.2, 6.3, 6.4 Clause 6.2d covers ER 13.3d
in respect of the labelling on
the unit container only and
only if the lot number is
preceded with the word
"LOT" (or the harmonized
symbol).
13.3e 6.2,6.3 Clause 6.2f covers ER 13.3e in
respect of the labelling on the
unit container only and only if
the expiry date is expressed in
the format year and month.
13.3f 6.2,6.3,6.4 Clause 6.2g covers ER 13.3f in
respect of the labelling on the
unit container only.
13.3g Not applicable
13.3h Not applicable
13.3i 6.3 Clause 6.3h covers ER 13.3i in
respect of the labelling on the
outer container only.
13.3j 6.2, 6.4 Clause 6.2 ER 13.3j but only in
respect of the labelling on the
unit container and only to the
extent given in the standard.
13.3k 6.4
13.3l Not applicable
Essential Requirements (ERs) Clause(s)/sub-clause(s) of Qualifying remarks/Notes
of Directive 93/42/EEC this European Standard
13.3m 6.2,6.3 Clause 6.2i covers ER 13.3m
but only in respect of the
labelling on the unit
container.
13.3n Not applicable
13.4 6.4
13.5 Not applicable
13.6a 6.4 Clause 6.4 covers ER 13.6a in
respect of all relevant clauses
of 13.3 except g, h and i.
13.6b 6.4 Clause 6.4 covers ER 13.6b to
the extent shown in the
standard.
Clause 6.4 does not cover
Directive Annex 1, ER 13.6b in
respect of undesirable side
effects.
13.6c 6.4 Clause 6.4f covers ER 13.6c to
the extent shown in the
standard.
13.6d Not applicable
13.6e Not applicable
13.6f Not applicable
13.6g Not applicable
13.6h Not Applicable
13.6i 6.2
13.6j Not applicable
13.6k Not applicable
13.6l Not applicable
13.6m 6.2 (exception i),6.4 Clause 6.2i does not cover, ER
13.6m.
13.6n Not applicable
13.6o Not applicable
13.6p Not applicable
13.6q Not applicable
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
The referenced documents shown in Table ZA.2 are indispensable for the application of this document.
For undated references, the latest edition of the referenced document (including any amendments)
applies. For dated references, only the edition cited applies. However, for any use of this standard
‘within the meaning of Annex ZA, the user should always check that any referenced document has not
been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table ZA.2 — Correlations between undated normative references and dated EN and ISO
standards
Normative references as
Equivalent dated standard
listed in Clause 2
EN ISO
ISO 7864 EN ISO 7864:2016 ISO 7864:2016
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-4 EN ISO 10993-4:2017 ISO 10993-4:2017
ISO 10993-7 EN ISO 10993-7:2008 ISO 10993-7:2008
ISO 10993-11 EN ISO 10993-11:2009 ISO 10993-11:2017
ISO 80369-7 EN ISO 80369-7:2017 ISO 80369-7:2016

INTERNATIONAL ISO
STANDARD 8637-2
First edition
2018-07
Extracorporeal systems for blood
purification —
Part 2:
Extracorporeal blood circuit for
haemodialysers, haemodiafilters and
haemofilters
Systèmes extracorporels pour la purification du sang —
Partie 2: Circuit sanguin extracorporel pour les hémodialyseurs, les
hémodiafiltres et les hémofiltres
Reference number
ISO 8637-2:2018(E)
©
ISO 2018
ISO 8637-2:2018(E)
© 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 other
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