SIST EN ISO 8637:2014
(Main)Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This International Standard is not applicable 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 used 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 8638.
Kardiovaskuläre Implantate und extrakorporale Systeme - Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren (ISO 8637:2010, einschließlich Änderung 1 2013-04-01)
Diese Internationale Norm legt Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren, nachstehend zusammenfassend als „das Gerät“ bezeichnet, für die Anwendung beim Menschen fest.
Die vorliegende Internationale Norm ist nicht anwendbar auf:
- 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 für die Durchführung von Hämodialyse, Hämodiafiltration, Hämofiltration oder Hämokonzent-ration;
- Verfahren und Ausrüstung für die Wiederaufbereitung.
ANMERKUNG Anforderungen an den extrakorporalen Blutkreislauf für Hämodialysatoren, Hämodiafilter und Hämofilter sind in ISO 8638 festgelegt.
Implants cardiovasculaires et systèmes extracorporels - Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs (ISO 8637:2010, Amendement 1 2013-04-01 inclus)
L'ISO 8637:2010 spécifie les exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs, collectivement appelés ci-après «dispositifs», utilisables chez l'homme.
Vsadki (implantati) za srce in ožilje ter zunajtelesni pretočni sistemi - Hemodializatorji, hemodiafiltri, hemofiltri in hemokoncentratorji (ISO 8637:2010, vključno z dopolnilom A1 2013-04-01)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8637:2014
01-april-2014
1DGRPHãþD
SIST EN 1283:2000
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMHWHU]XQDMWHOHVQLSUHWRþQLVLVWHPL
+HPRGLDOL]DWRUMLKHPRGLDILOWULKHPRILOWULLQKHPRNRQFHQWUDWRUML ,62
YNOMXþQR]GRSROQLORP$
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-
01)
Kardiovaskuläre Implantate und extrakorporale Systeme - Hämodialysatoren,
Hämodiafilter, Hämofilter und Hämokonzentratoren (ISO 8637:2010, einschließlich
Änderung 1 2013-04-01)
Implants cardiovasculaires et systèmes extracorporels - Hémodialyseurs, hémodiafiltres,
hémofiltres et hémoconcentrateurs (ISO 8637:2010, Amendement 1 2013-04-01 inclus)
Ta slovenski standard je istoveten z: EN ISO 8637:2014
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 8637:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 8637:2014
---------------------- Page: 2 ----------------------
SIST EN ISO 8637:2014
EUROPEAN STANDARD
EN ISO 8637
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2014
ICS 11.040.40 Supersedes EN 1283:1996
English Version
Cardiovascular implants and extracorporeal systems -
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators (ISO 8637:2010, including Amendment 1
2013-04-01)
Implants cardiovasculaires et systèmes extracorporels - Kardiovaskuläre Implantate und extrakorporale Systeme -
Hémodialyseurs, hémodiafiltres, hémofiltres et Hämodialysatoren, Hämodiafilter, Hämofilter und
hémoconcentrateurs (ISO 8637:2010, Amendement 1 Hämokonzentratoren (ISO 8637:2010, einschließlich
2013-04-01 inclus) Änderung 1 2013-04-01)
This European Standard was approved by CEN on 1 December 2013.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8637:2014 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 8637:2014
EN ISO 8637:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
2
---------------------- Page: 4 ----------------------
SIST EN ISO 8637:2014
EN ISO 8637:2014 (E)
Foreword
The text of ISO 8637:2010, including Amendment 1 2013-04-01 has been prepared by Technical Committee
ISO/TC 150 “Implants for surgery” of the International Organisation for Standardization (ISO) and has been
taken over as EN ISO 8637:2014 by 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 July 2014, and conflicting national standards shall be withdrawn at the
latest by July 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1283:1996.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8637:2010 has been approved by CEN as EN ISO 8637:2014 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 8637:2014
EN ISO 8637:2014 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices (1 of 2)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
4.1, 4.2, 4.3 7.2
4.1 7.3
4.1 7.4 Addressed only in general terms.
Blood-contacting surfaces
incorporating medicinal
products, such as heparin, are
not specifically addressed.
4.1, 6.4(n) 7.5 Addressed only in general terms.
Typically, these devices do not
incorporate materials containing
phthalates.
4.2, 4.3, 6.1(h), 6.1(i), 6.2(e), 8.1
6.2(f), 6.2(h), 6.3(f), 6.3(g),
6.4(c), 6.4(f), 6.4(g), 6.4(i)
4.2, 5.3 8.3 Addressed only in general terms.
4.2, 5.3 8.4
4.4.3, 4.4.4, 4.4.5, 4.4.6 9.1 Connectors are specified to
match tubing connectors
specified in ISO 8638 for the
blood compartment.
4.4.4 12.7.4
6 13.1
6.1, 6.2, 6.3, 6.4 13.2 The NOTE at the end of each
clause allows the use of symbols
from Harmonized Standards.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 8637:2014
EN ISO 8637:2014 (E)
Table ZA.1 (2 of 2)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6.1(a), 6.2(a), 6.3(a), 6.3(b), 13.3 (a)
6.4(a)
6.1(b), 6.1(c), 6.2(b), 6.2(c), 13.3 (b)
6.3(c), 6.3(d), 6.4(b), 6.4(e)
6.2(e), 6.3(f), 6.4(f) 13.3 (c)
6.1(d), 6.2(d), 6.3(e) 13.3 (d)
6.1(g), 6.2(g), 6.3(h) 13.3 (e)
6.1(i), 6.2(h), 6.4(g) 13.3 (f)
6.3(g) 13.3 (i)
6.4(c), 6.4(d), 6.4(i) 13.3 (j)
6.2(j), 6.4(d) 13.3 (k)
6.1(h), 6.2(f), 6.4(f) 13.3 (m)
6.4(a), 6.4(b), 6.4(e), 6.4(f), 13.6 (a) There is no requirement for the
6.4(g), 6.4(i), 6.4(f) information in 13.3 (i) in the
instructions for use. Instead, that
information is required to be
given on the outer container in
which the device is sold.
6.4(h) 13.6 (b)
6.4(l), 6.4(m) 13.6 (c)
6.2(h), 6.4(g), 6.4(i) 13.6 (h)
6.4(c), 6.4(d) 13.6 (i)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
---------------------- Page: 7 ----------------------
SIST EN ISO 8637:2014
---------------------- Page: 8 ----------------------
SIST EN ISO 8637:2014
INTERNATIONAL ISO
STANDARD 8637
Third edition
2010-07-01
Cardiovascular implants and
extracorporeal systems —
Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
Implants cardiovasculaires et systèmes extracorporels —
Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
Reference number
ISO 8637:2010(E)
©
ISO 2010
---------------------- Page: 9 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2010 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(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
4.5 Performance characteristics .6
4.6 Expiry date .7
5 Test methods .7
5.1 General .7
5.2 Biological safety.7
5.3 Sterility.7
5.4 Non-pyrogenicity .8
5.5 Mechanical characteristics.8
5.6 Performance characteristics .9
5.7 Expiry date .14
6 Labelling.14
6.1 Labelling on the device.14
6.2 Labelling on the unit containers .14
6.3 Labelling on the outer containers.15
6.4 Accompanying documentation.15
Bibliography.18
© ISO 2010 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 8637 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This third edition cancels and replaces the second edition (ISO 8637:2004), which has been technically
revised.
iv © ISO 2010 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(E)
Introduction
This International Standard is concerned with devices intended for haemodialysis, haemodiafiltration,
haemofiltration and haemoconcentration in humans. The requirements specified in this International Standard
will help to ensure safety and satisfactory function.
It was not found practicable to specify materials of construction. This International Standard therefore requires
only that materials 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 8638. The design and
dimensions have been selected in order to minimize the risk of leakage of blood and the ingress of air.
This International Standard reflects the consensus of physicians, manufacturers and other interested parties
for devices that are approved for clinical use. Conformance with this International Standard is voluntary and it
does not supersede any national regulation.
© ISO 2010 – All rights reserved v
---------------------- Page: 13 ----------------------
SIST EN ISO 8637:2014
---------------------- Page: 14 ----------------------
SIST EN ISO 8637:2014
INTERNATIONAL STANDARD ISO 8637:2010(E)
Cardiovascular implants and extracorporeal systems —
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
1 Scope
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This International Standard is not applicable 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 used 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 8638.
2 Normative references
The following referenced documents are indispensable for the application 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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
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 2010 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(E)
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 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 The term “dialysis fluid” is used throughout this International Standard to mean the fluid (made from dialysis
water and concentrates) which is delivered to the haemodialyser or haemodiafilter by the dialysis fluid delivery system.
Such phrases as “dialysate”, “dialysis solution” or “dialysing fluid” can be used in place of dialysis fluid.
NOTE 2 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 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
3.8
haemoconcentration
process whereby plasma water and electrolytes are removed from diluted blood across a semipermeable
membrane
2 © ISO 2010 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(E)
3.9
haemoconcentrator
device intended to perform haemoconcentration (3.8)
3.10
haemodiafilter
device intended to perform haemodiafiltration (3.11)
3.11
haemodiafiltration
process whereby solute imbalances in a patient's blood are corrected by means of simultaneous convection
and diffusion across a semipermeable membrane, and by replacement with an appropriate physiological fluid
NOTE Normally, the process also includes a net fluid removal.
3.12
haemodialyser
device intended to perform haemodialysis (3.13)
3.13
haemodialysis
process whereby solute imbalances in a patient's blood are corrected, mainly by diffusion across a
semipermeable membrane
NOTE Normally, the process also includes a net fluid removal.
3.14
haemofilter
device intended to perform haemofiltration (3.15)
3.15
haemofiltration
process whereby solute imbalances in a patient's blood are corrected, mainly by convection across a
semipermeable membrane and replacement with an appropriate physiological fluid
NOTE Normally, the process also includes a net fluid removal.
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
3.17
sieving coefficient
ratio of a solute concentration in the filtrate to the simultaneous concentration of the same solute in the plasma
© ISO 2010 – All rights reserved 3
---------------------- Page: 17 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(E)
3.18
transmembrane pressure
TPM
p
TM
mean pressure exerted across a semipermeable membrane
NOTE 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
or
⎯ 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 × the manufacturer's recommended
maximum pressure and a negative pressure not exceeding 700 mmHg (93,3 kPa below atmospheric
pressure) or the highest obtainable negative pressure if at high elevation, when tested according to 5.5.1.
NOTE This requirement refers to the external case integrity of the device.
4.4.2 Blood compartment integrity
When exposing the blood compartment to a validated test procedure performed at 1,5 × 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 © ISO 2010 – All rights reserved
---------------------- Page: 18 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(E)
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.
Dimensions in millimetres
a
Double thread.
Figure 1 — Main fitting dimensions of blood inlet and outlet ports
4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports
Except where the haemodialyser or haemodiafilter and the dialysis fluid circuit are designed as an integral
system, the dimensions of the dialysis fluid compartment ports shall be as given in Figure 2. Compliance with
this requirement shall be verified in accordance with 5.5.4.
4.4.5 Haemofilter filtrate ports
Except where the haemofilter and the filtrate circuit are designed as an integral system, the filtrate ports of
haemofilters shall comply either with Figure 2 or with the requirements of the Luer lock fitting of ISO 594-2.
Compliance with this requirement shall be verified in accordance with 5.5.5.
4.4.6 Haemoconcentrator blood and filtrate ports
The blood and filtrate ports of haemoconcentrators shall allow for a secure connection to the tubing which is to
be used with the device. Compliance with this requirement shall be verified in accordance with 5.5.6.
© ISO 2010 – All rights reserved 5
---------------------- Page: 19 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(E)
Dimensions in millimetres
Figure 2 — Main fitting dimensions of dialysis fluid inlet and outlet ports
4.5 Performance characteristics
4.5.1 Clearance of haemodialysers and haemodiafilters
The clearance of urea, creatinine, phosphate and vitamin B shall be determined in accordance with 5.6.1.
12
Blood and dialysis fluid flow rates shall cover the manufacturer's specified range.
NOTE As a supplement, K A results can be included.
0
4.5.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators
The sieving coefficient for albumin, inulin and myoglobin or β -microglobulin shall be determined in
2
accordance with 5.6.2.
4.5.3 Ultrafiltration coefficient
The ultrafiltration coefficient shall be determined in accordance with 5.6.3. Testing shall be conducted over the
manufacturer's specified range of transmembrane pressures and blood flow rates.
4.5.4 Volume of the blood compartment
The volume of the blood compartment shall be determined in accordance with 5.6.4 over the specified range
of transmembrane pressures.
NOTE If the blood compartment is noncompliant, it is acceptable to determine the volume at one transmembrane
pressure.
6 © ISO 2010 – All rights reserved
---------------------- Page: 20 ----------------------
SIST EN ISO 8637:2014
ISO 8637:2010(E)
4.5.5 Pressure drop of the blood compartment
The pressure drop of the blood compartment shall be determined in accordance with 5.6.5.
4.6 Expiry date
The biological safety, sterility and mechanical integrity of the device shall be proven after storage for a period
corresponding to the expiry date. Compliance shall be in acc
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.