EN ISO 1135-4:2012

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)

ISO 1135-4:2011 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 1135-4:2011 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 1135-4:2011.

Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-4:2012)

Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non réutilisables (ISO 1135-4:2012)

L'ISO 1135-4:2012 spécifie les exigences applicables aux appareils de transfusion à usage médical, non réutilisables, afin d'assurer leur compatibilité avec les conteneurs renfermant du sang et des composants du sang, ainsi qu'avec les appareils intraveineux.
Les objectifs secondaires de l'ISO 1135-4:2012 sont de donner des lignes directrices sur les spécifications relatives à la qualité et aux performances des matériaux utilisés dans les appareils de transfusion, et de proposer une terminologie relative aux composants de ces derniers.
Dans certains pays, la pharmacopée nationale ou d'autres réglementations nationales sont légalement contraignantes et priment sur l'ISO 1135-4:2012.

Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za enkratno uporabo (ISO 1135-4:2012)

Ta del standarda ISO 1135 določa 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. Druga cilja tega dela standarda ISO 1135 sta zagotoviti navodila za specifikacije v zvezi s kakovostjo in učinkovitostjo materialov, uporabljenih za transfuzijske garniture, ter predstaviti oznake za sestavne dele transfuzijskih garnitur. V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 1135.

General Information

• Status: Withdrawn
• Publication Date: 29-Feb-2012
• Withdrawal Date: 22-Dec-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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: 23-Dec-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 1135-4:2012 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)

Relations

• Replaces: EN ISO 1135-4:2011 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
• Effective Date: 08-Oct-2011
• Replaced By: EN ISO 1135-4:2015 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 1135-5:2015 - Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 1135-4:2012
01-maj-2012
1DGRPHãþD
SIST EN ISO 1135-4:2012
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2012)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO
1135-4:2012)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2012)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2012)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2012
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
March 2012
ICS 11.040.20 Supersedes EN ISO 1135-4:2011
English Version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2012)
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-
4:2012) 4:2012)
This European Standard was approved by CEN on 29 February 2012.

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, Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2012: E
worldwide for CEN national Members.

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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2012 (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

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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2012 (E)
Foreword
This document (EN ISO 1135-4:2012) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection, and blood processing 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 September 2012, and conflicting national standards shall be
withdrawn at the latest by September 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 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, Italy, Latvi
...