EN ISO 8637:2014

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

• Status: Withdrawn
• Publication Date: 14-Jan-2014
• Withdrawal Date: 14-Apr-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 15-Apr-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 8637:2014 - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)

Relations

• Replaces: EN 1283:1996 - Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 8637-1:2020 - Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
• Effective Date: 22-Apr-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8637:2014
01-april-2014
1DGRPHãþD
SIST EN 1283:2000
9VDGNLLPSODQWDWL]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.

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SIST EN ISO 8637:2014

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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.

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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

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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 th
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