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)
ISO 8637:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
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
01-april-2014
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SIST EN 1283:2000
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
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.
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.
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
ISO 8637:2010(E)
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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
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