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SIST EN ISO 8637-2:2018
01-december-2018
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SIST EN ISO 8638:2014
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Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
Extrakorporale Systeme zur Blutreinigung - Teil 2: Extrakorporaler Blutkreislauf bei
Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8637-2:2018)
Systèmes extracorporels pour la purification du sang - Partie 2: Circuit sanguin
extracorporel pour les hémodialyseurs, les hémodiafiltres et les hémofiltres (ISO 8637-
2:2018)
Ta slovenski standard je istoveten z: EN ISO 8637-2:2018
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8637-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8637-2:2018
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SIST EN ISO 8637-2:2018
EN ISO 8637-2
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2018
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 8638:2014
English Version
Extracorporeal systems for blood purification - Part 2:
Extracorporeal blood circuit for haemodialysers,
haemodiafilters and haemofilters (ISO 8637-2:2018)
Systèmes extracorporels pour la purification du sang - Kardiovaskuläre Implantate und extrakorporale
Partie 2: Circuit sanguin extracorporel pour les Système - Teil 2: Extrakorporaler Blutkreislauf bei
hémodialyseurs, les hémodiafiltres et les hémofiltres Hämodialysatoren, Hämodiafiltern und Hämofiltern
(ISO 8637-2:2018) (ISO 8637-2:2018)
This European Standard was approved by CEN on 17 June 2018.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 26 September 2018.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8637-2:2018 E
worldwide for CEN national Members.
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SIST EN ISO 8637-2:2018
EN ISO 8637-2:2018 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 4
2
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SIST EN ISO 8637-2:2018
EN ISO 8637-2:2018 (E)
European foreword
This document (EN ISO 8637-2:2018) 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 February 2019, and conflicting national standards
shall be withdrawn at the latest by August 2021.
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 8638:2014.
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
...