EN ISO 8637-1:2020

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
-      extracorporeal blood circuits;
-      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;
-      reprocessing procedures and equipment.
NOTE       Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.

Extrakorporale Systeme für die Blutreinigung - Teil 1: Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren (ISO 8637-1:2017)

WARNUNG — Für Produkte, die unter den Anwendungsbereich dieser Norm fallen, können andere Anforderungen und andere EU Richtlinien anwendbar sein.
Dieses Dokument legt Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzen-tratoren, nachstehend zusammenfassend als „das Gerät“ bezeichnet, für die Anwendung beim Menschen fest.
Dieses Dokument gilt nicht für:
—   extrakorporale Blutkreisläufe;
—   Plasmafilter;
—   Hämoperfusionsgeräte;
—   Geräte für den vaskulären Zugang;
—   Blutpumpen;
—   Druckaufzeichnungsgeräte für extrakorporale Blutkreisläufe;
—   Luftnachweisgeräte;
—   Systeme für die Herstellung, Aufbewahrung oder Überwachung der Dialyseflüssigkeit;
—   Systeme und Geräte für die Durchführung von Hämodialyse, Hämodiafiltration, Hämofiltration oder Hämokonzentration;
—   Verfahren und Ausrüstung für die Wiederaufbereitung.
ANMERKUNG   Anforderungen an den extrakorporalen Blutkreislauf für Hämodialysatoren, Hämodiafilter und Hämo¬filter sind in ISO 8637 2 festgelegt.

Systèmes extracorporels pour la purification du sang - Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs (ISO 8637-1:2017)

L'ISO 8637-1:2017 spécifie les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs, collectivement appelés ci-après «dispositifs», utilisables chez l'homme.
L'ISO 8637-1:2017 ne s'applique pas:
-      aux circuits sanguins extracorporels;
-      aux filtres pour plasma;
-      aux dispositifs d'hémoperfusion;
-      aux dispositifs d'accès vasculaire;
-      aux pompes sanguines;
-      aux moniteurs de pression du circuit sanguin extracorporel;
-      aux dispositifs de détection d'air;
-      aux systèmes de préparation, de conservation ou de contrôle du liquide de dialyse;
-      aux systèmes ou à l'équipement destinés à effectuer une hémodialyse, une hémodiafiltration, une hémofiltration ou une hémoconcentration;
-      aux modes opératoires et au matériel de retraitement.
NOTE       Les exigences relatives au circuit sanguin extracorporel pour les hémodialyseurs, hémodiafiltres et hémofiltres sont spécifiées dans l'ISO 8637‑2.

Zunajtelesni pretočni sistemi za čiščenje krvi - 1. del: Hemodializatorji, hemodiafiltri, hemofiltri in hemokoncentratorji (ISO 8637-1:2017)

General Information

• Status: Published
• Publication Date: 14-Apr-2020
• 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: 15-Apr-2020
• Completion Date: 15-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 8637-1:2020 - Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

Relations

• Replaces: EN ISO 8637:2014 - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
• Effective Date: 22-Apr-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2020
Nadomešča:
SIST EN ISO 8637:2014
Zunajtelesni pretočni sistemi za čiščenje krvi - 1. del: Hemodializatorji,
hemodiafiltri, hemofiltri in hemokoncentratorji (ISO 8637-1:2017)
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators (ISO 8637-1:2017)
Kardiovaskuläre Implantate und extrakorporale Système - Teil 1: Hämodialysatoren,
Hämodiafilter, Hämofilter und Hämokonzentratoren (ISO 8637-1:2017)
Systèmes extracorporels pour la purification du sang - Partie 1: Hémodialyseurs,
hémodiafiltres, hémofiltres et hémoconcentrateurs (ISO 8637-1:2017)
Ta slovenski standard je istoveten z: EN ISO 8637-1:2020
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 8637-1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2020
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 8637:2014
English Version
Extracorporeal systems for blood purification - Part 1:
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators (ISO 8637-1:2017)
Systèmes extracorporels pour la purification du sang - Kardiovaskuläre Implantate und extrakorporale
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres Système - Teil 1: Hämodialysatoren, Hämodiafilter,
et hémoconcentrateurs (ISO 8637-1:2017) Hämofilter und Hämokonzentratoren (ISO 8637-
1:2017)
This European Standard was approved by CEN on 8 April 2020.

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, 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 8637-1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8637-1:2020) 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 April 2023.
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 8637:2014.
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 8637-1:2017 has been approved by CEN as EN ISO 8637-1:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 8637-1
First edition
2017-11
Extracorporeal systems for blood
purification —
Part 1:
Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et
hémoconcentrateurs
Reference number
ISO 8637-1:2017(E)
©
ISO 2017
ISO 8637-1:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 8637-1:2017(E)
Contents  Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  Requirements . 4
4.1 Biological safety . 4
4.2 Sterility . 4
4.3 Non-pyrogenicity . 4
4.4 Mechanical characteristics. 4
4.4.1 Structural integrity . 4
4.4.2 Blood compartment integrity . 5
4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports . 5
4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports . 8
4.4.5 Haemofilter filtrate ports . 8
4.4.6 Haemoconcentrator blood and filtrate ports . 8
4.5 Performance characteristics. 8
4.5.1 Solute clearance of haemodialysers and haemodiafilters . 8
4.5.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators . 9
4.5.3 Ultrafiltration coefficient . 9
4.5.4 Volume of the blood compartment . 9
4.5.5 Pressure drop of the blood compartment . 9
4.6 Expiry date. 9
5 Test methods . 9
5.1 General . 9
5.2 Biological safety .10
5.3 Sterility .10
5.4 Non-pyrogenicity .10
5.5 Mechanical characteristics.10
5.5.1 Structural integrity .10
5.5.2 Blood compartment integrity .11
5.5.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports .11
5.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports .11
5.5.5 Haemofilter filtrate ports .11
5.5.6 Haemoconcentrator blood and filtrate ports .11
5.6 Performance characteristics.13
5.6.1 Clearance .13
5.6.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators .15
5.6.3 Ultrafiltration coefficient .16
5.6.4 Volume of the blood compartment .17
5.6.5 Pressure drop of the blood compartment .17
5.7 Expiry date.17
6  Labelling .17
6.1 Labelling on the device .17
6.2 Labelling on unit containers .18
6.3 Labelling on the outer containers.18
6.4 Information to be given in the accompanying documentation .19
Bibliography .
...