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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Apr-2020
Completion Date
15-Apr-2020

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SLOVENSKI STANDARD
SIST EN ISO 8637-1:2020
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
SIST EN ISO 8637-1:2020 en

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

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SIST EN ISO 8637-1:2020
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SIST EN ISO 8637-1:2020
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.
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SIST EN ISO 8637-1:2020
EN ISO 8637-1:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 8637-1:2020
EN ISO 8637-1:2020 (E)
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.
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SIST EN ISO 8637-1:2020
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SIST EN ISO 8637-1:2020
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
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© 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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 8637-1:2020
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 .............................................................................................................................................................................................................................22

© ISO 2017 – All rights reserved iii
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: www.iso.org/iso/foreword.html.

This document was prepared by Technical committee ISO/TC 150, Implants for surgery, Subcommittee

SC 2, Cardiovascular implants and extracorporeal systems.

This first edition of ISO 8637-1:2017 cancels and replaces the third edition of ISO 8637:2010 and

ISO 8637:2010/Amd1:2013, which has been technically revised. The following changes have been done:

— Figure 1, Figure 2, and Figure 3 have been revised.
A list of all the parts in the ISO 8637 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)
Introduction

This document is concerned with devices intended for haemodialysis, haemodiafiltration,

haemofiltration and haemoconcentration in humans. The requirements specified in this document will

help to ensure safety and satisfactory function.

It was not found practicable to specify materials of construction. This document therefore requires

only that materials which have been used have been tested and that the methods and results are

made available upon request. There is no intention to specify, or to set limits on, the performance

characteristics of the devices because such restrictions are unnecessary for the qualified user and

would limit the alternatives available when choosing a device for a specific application.

The dimensions of the blood ports and the dialysis fluid or filtrate ports have been specified to ensure

compatibility of the device with the extracorporeal blood circuit specified in ISO 8637-2. The design and

dimensions have been selected in order to minimize the risk of leakage of blood and the ingress of air.

This document reflects the consensus of physicians, manufacturers and other interested parties for

devices that are approved for clinical use. Conformance with this document is voluntary and it does not

supersede any national regulation.
© ISO 2017 – All rights reserved v
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SIST EN ISO 8637-1:2020
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SIST EN ISO 8637-1:2020
INTERNATIONAL STANDARD ISO 8637-1:2017(E)
Extracorporeal systems for blood purification —
Part 1:
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
1 Scope

WARNING — Other requirements and other EU Directives may be applicable to the product(s)

falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and

haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document 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.
2  Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

© ISO 2017 – All rights reserved 1
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)

ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors

for intravascular or hypodermic applications
3  Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
blood compartment

part of a haemodialyser (3.12), haemodiafilter (3.10), haemofilter (3.14) or haemoconcentrator (3.9)

through which blood is intended to pass

Note 1 to entry: For hollow-fibre devices, the blood compartment includes the volume of the hollow fibres plus

the headers.
3.2
clearance
volume of a solution from which a solute is completely removed per unit time
3.3
convection

transport of solutes across a semipermeable membrane, along with filtered fluid, caused by a pressure

gradient or pressure differential across the membrane
3.4
dialysis fluid

aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange

solutes with blood during haemodialysis (3.13) or haemodiafiltration (3.11)

Note 1 to entry: The term “dialysis fluid” is used throughout this document to mean the fluid (made from dialysis

water and concentrates) which is delivered to the haemodialyser or haemodiafilter by a dialysis fluid delivery

system. Phrases such as “dialysate”, “dialysis solution” or “dialysing fluid” can be used in place of dialysis fluid.

Note 2 to entry: The dialysis fluid entering the haemodialyser or haemodiafilter is referred to as “fresh dialysis

fluid”, while the fluid leaving the haemodialyser or haemodiafilter is referred to as “spent dialysis fluid”.

Note 3 to entry: Dialysis fluid does not include pre-packaged parenteral fluids used in some renal replacement

therapies, such as haemodiafiltration and haemofiltration.
3.5
dialysis fluid compartment

part of a haemodialyser (3.12) or haemodiafilter (3.10) through which dialysis fluid (3.4) is intended to pass

3.6
diffusion

transport of solutes across a semipermeable membrane, caused by a concentration gradient

3.7
filtrate

fluid removed from the blood across the semipermeable membrane into the dialysis fluid or filtrate

compartment of a haemodialyser (3.12), haemodiafilter (3.10), haemofilter (3.14) or haemoconcentrator

(3.9), due to a pressure gradient (including the contributions of both hydrostatic and oncotic pressures)

across the semipermeable membrane
2 © ISO 2017 – All rights reserved
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)
3.8
haemoconcentration

process whereby plasma water and electrolytes are removed from diluted blood across a semipermeable

membrane
3.9
haemoconcentrator
device intended to perform haemoconcentration (3.8)
3.10
haemodiafilter
device intended to perform haemodiafiltration (3.11)
3.11
haemodiafiltration

form of renal replacement therapy in which the waste solutes are removed from blood by a combination

of diffusion and enhanced convection through a high flux or high permeability membrane

Note 1 to entry: Diffusive solute removal is achieved using a dialysis fluid stream as in haemodialysis. Enhanced

convective solute removal is achieved by adding ultrafiltration in excess of that needed to achieve the desired

weight loss; fluid balance is maintained by the infusion of a replacement solution into the blood circuit either

before (predilution haemodiafiltration) or after (post-dilution haemodiafiltration) or a combination of the two

(mixed dilution haemodiafiltration).
3.12
haemodialyser
device intended to perform haemodialysis (3.13)
3.13
haemodialysis

form of renal replacement therapy in which waste solutes from the blood are removed primarily by

diffusion across a semi permeable membrane contained in a haemodialyser in which the blood flows on

one side of the membrane and dialysis fluid flowing on the other

Note 1 to entry: Fluid removal that is sufficient to achieve the desired weight loss is achieved by a hydrostatic

pressure gradient across the membrane. This fluid removal provides some additional solute removal particularly

for higher molecular weight compounds.
3.14
haemofilter
device intended to perform haemofiltration (3.15)
3.15
haemofiltration

a form of renal replacement therapy in which waste solutes are removed from the blood by convection

Note 1 to entry: Convective transport is achieved by ultrafiltration across a high flux membrane. Fluid balance

is maintained by the infusion of a replacement solution into the blood either before the haemofilter (predilution

haemofiltration) or after the haemofilter (post-dilution haemofiltration) or a combination of the two (mixed

dilution haemofiltration).
Note 2 to entry: In haemofiltration there is no dialysis fluid stream.
3.16
labelling

written, printed, graphic or electronic matter that is affixed to a medical device or any of its containers

or wrappers, or accompanies a medical device and which is related to identification, technical

description and use of that medical device, but excluding shipping documents
© ISO 2017 – All rights reserved 3
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)
3.17
sieving coefficient

ratio of a solute concentration in the filtrate to the simultaneous concentration of the same solute in

the plasma
3.18
transmembrane pressure
TMP
mean pressure exerted across a semipermeable membrane

Note 1 to entry: For practical reasons, the mean TMP is generally expressed as either:

— the difference between arithmetic means of inlet and outlet pressures of the blood and dialysis fluid

compartments of a haemodialyser or a haemodiafilter

— the difference between the arithmetic mean of the inlet and outlet pressures of the blood compartment and

the filtrate pressure of a haemofilter or a haemoconcentrator
3.19
ultrafiltration coefficient

permeability of membrane to water, generally expressed in millilitres per hour per millimetre of mercury

4  Requirements
4.1  Biological safety

Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated

for freedom from biological hazards, in accordance with 5.2. If the device is labelled for reuse, testing

shall be performed after reprocessing following the manufacturer's instructions for use.

Attention is drawn to the need to establish whether national regulations or national standards

governing toxicology and biocompatibility testing exist in the country in which the device is produced

and, if applicable, in the countries in which the device is to be marketed.
4.2  Sterility

The blood pathway of the device shall be sterile. Compliance shall be verified in accordance with 5.3.

4.3  Non-pyrogenicity

The blood pathway of the device shall be non-pyrogenic. Compliance shall be verified in accordance

with 5.4.
4.4  Mechanical characteristics
4.4.1  Structural integrity

The device shall be capable of withstanding a positive pressure of 1,5 times the manufacturer's

recommended maximum pressure above atmospheric pressure and a negative pressure not exceeding

700 mmHg (93,3 kPa) below atmospheric pressure, when tested according to 5.5.1.
NOTE This requirement refers to the external case integrity of the device.
4 © ISO 2017 – All rights reserved
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)
4.4.2  Blood compartment integrity

When exposing the blood compartment to a validated test procedure performed at 1,5 times the

manufacturer's maximum recommended transmembrane pressure, the blood compartment shall not

leak. Compliance with this requirement shall be verified in accordance with 5.5.2.

4.4.3  Haemodialyser, haemodiafilter and haemofilter blood compartment ports

Except where the haemodialyser, haemodiafilter or haemofilter and the extracorporeal blood circuit

are designed as an integral system, the dimensions of the blood ports shall be as given in Figure 1.

Compliance with this requirement shall be verified in accordance with 5.5.3.
© ISO 2017 – All rights reserved 5
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)
6 © ISO 2017 – All rights reserved
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SIST EN ISO 8637-1:2020
ISO 8637-1:2017(E)
Key
Symbol Designation Dimension in mm Comments
α Angle of thread 15° —
β Angle of thread 15° —
γ Dimension taper rate 6:100 —
E Length of thread 10 or more —
F Length of tapered region 9 or more —
The superscript “a” of G means
G Thread pitch 8
double thread.
H Root diameter 13 or more —
...

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