EN ISO 8638:2014

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

• Status: Withdrawn
• Publication Date: 14-Jan-2014
• Withdrawal Date: 21-Aug-2018
• 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: 22-Aug-2018
• 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 8638:2014 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)

Relations

• Replaces: EN 1283:1996 - Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 8637-2:2018 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
• Effective Date: 02-Mar-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8638:2014
01-april-2014
1DGRPHãþD
SIST EN 1283:2000
9VDGNLLPSODQWDWL]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
SIST EN ISO 8638:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8638:2014

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SIST EN ISO 8638:2014

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.

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SIST EN ISO 8638:2014
EN ISO 8638:2014 (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 8638:2014
EN ISO 8638:2014 (E)
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
...