EN ISO 1135-4:2011
(Main)Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
ISO 1135-4:2010 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of ISO 1135-4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2010.
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur einmaligen Verwendung (ISO/FDIS 1135-4:2011)
Dieser Teil von ISO 1135 legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische
Transfusionsgeräte fest, um sicherzustellen, dass sie zur Verwendung mit Behältern für Blut und Blutbestandteile
und Geräten zur intravenösen Punktion geeignet sind.
Zweitrangige Ziele dieses Teils von ISO 1135 sind die Schaffung einer Anleitung zu Spezifikationen der
Qualität und Leistungsfähigkeit von Werkstoffen, die für Transfusionsgeräte verwendet werden, und die
Angabe von Benennungen für Einzelteile von Transfusionsgeräten.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und
haben Vorrang vor diesem Teil von ISO 1135.
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non réutilisables (ISO 1135-4:2010)
L'ISO 1135-4:2010 sp�cifie les exigences applicables aux appareils de transfusion � usage m�dical, non r�utilisables, afin d'assurer leur compatibilit� avec les conteneurs renfermant du sang et des composants du sang, ainsi qu'avec les appareils intraveineux.
Le deuxi�me objectif de l'ISO 1135-4:2010 est de donner des directives sur les sp�cifications relatives � la qualit� et aux performances des mat�riaux utilis�s dans les appareils de transfusion, et de proposer une terminologie relative aux composants de ces derniers.
Dans certains pays, la pharmacop�e nationale ou d'autres r�glementations nationales sont l�galement contraignantes et priment sur l'ISO 1135-4:2010.
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za enkratno uporabo (ISO 1135-4:2010)
Ta del ISO 1135 opredeljuje zahteve za transfuzijske garniture za enkratno uporabo v medicini, da se zagotovi njihova združljivost z vsebniki za kri in krvne sestavine ter z intravenozno opremo. Drugotni cilji tega dela ISO 1135 so zagotoviti napotke glede specifikacij, ki se nanašajo na kakovost in delovanje materialov, ki se uporabljajo v transfuzijskih garniturah, in predstaviti oznake za sestavne dele transfuzijskih garnitur. V nekaterih državah so farmakopeja države ali drugi predpisi države pravno zavezujoči in imajo prednost pred tem delom ISO 1135.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 1135-4:2012
01-januar-2012
1DGRPHãþD
SIST EN ISO 1135-4:2010
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2010)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO
1135-4:2010)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2010)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2010)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2011
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 1135-4:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 1135-4:2012
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SIST EN ISO 1135-4:2012
EUROPEAN STANDARD
EN ISO 1135-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2011
ICS 11.040.20 Supersedes EN ISO 1135-4:2010
English Version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2010)
Matériel de transfusion à usage médical - Partie 4: Transfusionsgeräte zur medizinischen Verwendung - Teil 4:
Appareils de transfusion non réutilisables (ISO 1135- Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-
4:2010) 4:2010)
This European Standard was approved by CEN on 20 September 2011.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2011: E
worldwide for CEN national Members.
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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2011 (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 1135-4:2012
EN ISO 1135-4:2011 (E)
Foreword
This document (EN ISO 1135-4:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection equipment for medical and pharmaceutical use" 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 April 2012, and conflicting national standards shall be withdrawn at the
latest by April 2012.
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 ISO 1135-4:2010.
This new edition contains a revised Annex ZA.
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.
For relationship with EU Directive, 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, France, Germany, Greece, Hungary, Iceland, Ireland
...
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