EN ISO 8638:2014
(Main)Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
ISO 8638:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
Kardiovaskuläre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8638:2010)
Diese Internationale Norm legt Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren (nachstehend als 'das Gerät' bezeichnet) sowie (integrale und nicht integrale) Schutzvorrichtungen für Messwandler ('Transducer-Protector') für die Anwendung bei Hämodialyse, Hämodiafiltration und Hämofiltration fest.
Die vorliegende Internationale Norm ist nicht anwendbar auf:
- Hämodialysatoren, Hämodiafilter oder 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 Ausrüstungen für die Durchführung von Hämodialyse, Hämodiafiltration, Hämofiltration oder Hämokonzent¬ration.
ANMERKUNG Anforderungen an Hämodialysatoren, Hämodiafilter, Hämofilter und Hämokonzentratoren sind in ISO 8637 festgelegt.
Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8638:2010)
L'ISO 8638:2010 spécifie des exigences relatives aux hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs (appelés ci-après «dispositifs») et aux dispositifs de protection des capteurs (intégrés et non intégrés) utilisables dans le cadre d'opérations d'hémodialyse, d'hémodiafiltration et d'hémofiltration.
Vsadki (implantati) za srce in ožilje ter zunajtelesni pretočni sistemi - Zunajtelesni krvni obtok za hemodializatorje, hemodiafiltre in hemofiltre (ISO 8638:2010)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2014
1DGRPHãþD
SIST EN 1283:2000
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMHWHU]XQDMWHOHVQLSUHWRþQLVLVWHPL=XQDMWHOHVQL
NUYQLREWRN]DKHPRGLDOL]DWRUMHKHPRGLDILOWUHLQKHPRILOWUH ,62
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
Kardiovaskuläre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf
bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8638:2010)
Implants cardiovasculaires et systèmes extracorporels - Circuit sanguin extracorporel
pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8638:2010)
Ta slovenski standard je istoveten z: EN ISO 8638:2014
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 8638
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2014
ICS 11.040.40 Supersedes EN 1283:1996
English Version
Cardiovascular implants and extracorporeal systems -
Extracorporeal blood circuit for haemodialysers, haemodiafilters
and haemofilters (ISO 8638:2010)
Implants cardiovasculaires et systèmes extracorporels - Kardiovaskuläre Implantate und extrakorporale Systeme -
Circuit sanguin extracorporel pour les hémodialyseurs, les Extrakorporaler Blutkreislauf bei Hämodialysatoren,
hémodiafiltres et les hémofiltres (ISO 8638:2010) Hämodiafiltern und Hämofiltern (ISO 8638:2010)
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 8638:2014 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 8638:2010 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 8638:2014 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 1283:1986.
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 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8638:2010 has been approved by CEN as EN ISO 8638:2014 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
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, 6.3(q) 7.5 Addressed only in general terms.
Although these devices can
incorporate materials containing
phthalates, there is no specific
requirement that the presence of
phthalates be indicated in the
labelling.
4.4.1, 4.4.9 7.6
4.2, 4.4.1, 4.4.6, 4.4.9, 6.2(e), 8.1
6.2(j), 6.4(f), 6.4(i), 6.4(n)
4.2, 5.3 8.3 Addressed only in general terms.
4.2, 5.3 8.4
4.4.2, 4.4.3, 4.4.4, 4.4.9.2 9.1 Connectors are specified to
match tubing connectors
specified in ISO 8637 for the
blood compartment.
4.4.6.1, 4.4.10, 4.6 9.2
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.
6.2(a), 6.3(a), 6.3(b), 6.4(a) 13.3 (a)
6.2(b), 6.2(c), 6.3(c), 6.3(d), 13.3 (b)
6.4(b), 6.4(c)
6.2(e), 6.3(f), 6.4(d) 13.3 (c)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6.2(d), 6.3(e) 13.3 (d)
6.2(f), 6.3(g) 13.3 (e)
6.2(g), 6.4(e) 13.3 (f)
6.3(h) 13.3 (i)
6.2(j), 6.4(g), 6.4(i), 6.4(l), 13.3 (j)
6.4(m), 6.4(o)
6.2(j), 6.4(f) 13.3 (k)
6.2(i) 13.3 (m)
6.4(a), 6.4(b), 6.4(c), 6.4(d), 13.6 (a) There is no requirement for the
6.4(e), 6.4(f), 6.4(g), 6.4(i), 6.4(l), information in 13.3(i) in the
instructions for use. Instead, that
6.4(m), 6.4(o)
information is required to be
given on the outer container in
which the device is sold.
6.4(r) 13.6 (c)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 8638
Third edition
2010-07-01
Cardiovascular implants and
extracorporeal systems — Extracorporeal
blood circuit for haemodialysers,
haemodiafilters and haemofilters
Implants cardiovasculaires et systèmes extracorporels — Circuit
sanguin extracorporel pour les hémodialyseurs, les hémodiafiltres et les
hémofiltres
Reference number
ISO 8638:2010(E)
©
ISO 2010
ISO 8638:2010(E)
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ISO 8638:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Requirements.2
4.1 Biological safety.2
4.2 Sterility.3
4.3 Non-pyrogenicity .3
4.4 Mechanical characteristics.3
4.5 Expiry date .5
4.6 Tubing compliance.5
5 Test methods .5
5.1 General .5
5.2 Biological safety.6
5.3 Sterility.6
5.4 Non-pyrogenicity .6
5.5 Mechanical characteristics.6
5.6 Expiry date .9
5.7 Tubing compliance.9
6 Labelling.10
6.1 Labelling on the device.10
6.2 Labelling on the unit container .10
6.3 Labelling on the outer container.10
6.4 Accompanying documentation.11
Bibliography.13
...
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