EN ISO 1135-4:2015

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)

ISO 1135-4:2015 specifies requirements for single use transfusion gravity 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 1135-4:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.

Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für Schwerkrafttransfusionen zur einmaligen Verwendung (ISO 1135-4:2015)

Dieser Teil von ISO 1135 legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische Transfusionsgeräte für Schwerkrafttransfusionen fest, um sicherzustellen, dass sie zur Verwendung mit Behältern für Blut und Blutbestandteile und Geräten zur intravenösen Punktion geeignet sind.
Weitere Ziele dieses Teils von ISO 1135 sind die Bereitstellung einer Anleitung zu Spezifikationen der Qualität und Leistungsfähigkeit von Werkstoffen, die für Transfusionsgeräte verwendet werden, die Angabe von Benennungen für Einzelteile von Transfusionsgeräten und die Sicherstellung der Kompatibilität der Geräte mit einer Reihe von Zell- und Blutplasmabestandteilen.
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 à alimentation par gravité (ISO 1135-4:2015)

ISO 1135-4:2015 spécifie les exigences relatives aux appareils de transfusion non réutilisables à alimentation par gravité à usage médical, afin d'assurer leur compatibilité avec les conteneurs de sang et de composants sanguins, ainsi qu'avec les dispositifs intraveineux.
Les objectifs secondaires de l'ISO 1135-4:2015 consistent à fournir des préconisations concernant les spécifications de qualité et de performance des matériaux utilisés dans les appareils de transfusion, de proposer des désignations pour les composants de ces appareils de transfusion, et d'assurer la compatibilité de ces appareils avec un large éventail de produits cellulaires et plasmiques du sang.
Dans certains pays, la pharmacopée ou d'autres règlements nationaux sont légalement obligatoires et ont donc préséance sur l'ISO 1135-4:2015.

Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za enkratno uporabo, delujoče na osnovi gravitacije (ISO 1135-4:2015)

Ta del standarda ISO 1135 določa zahteve za transfuzijske garniture za enkratno uporabo, delujoče na osnovi gravitacije, 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, predstaviti oznake za sestavne dele transfuzijskih garnitur, ter zagotoviti združljivost garnitur z naborom celičnih in plazemskih krvnih sestavin.
V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 1135.

General Information

• Status: Published
• Publication Date: 22-Dec-2015
• Withdrawal Date: 29-Jun-2016
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Dec-2015
• 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 1135-4:2016 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)

Relations

• Replaces: EN ISO 1135-4:2012 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)
• Effective Date: 08-Jun-2022
• Revised: prEN ISO 1135-4 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO/DIS 1135-4:2023)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 1135-4:2016
01-marec-2016
1DGRPHãþD
SIST EN ISO 1135-4:2012
7UDQVIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO7UDQVIX]LMVNHJDUQLWXUH]D
HQNUDWQRXSRUDERGHOXMRþHQDRVQRYLJUDYLWDFLMH,62
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity
feed (ISO 1135-4:2015)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für
Schwerkrafttransfusionen zur einmaligen Verwendung (ISO 1135-4:2015)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables à alimentation par gravité (ISO 1135-4:2015)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 1135-4:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 1135-4:2016

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SIST EN ISO 1135-4:2016


EN ISO 1135-4
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2015
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 1135-4:2012
English Version

Transfusion equipment for medical use - Part 4:
Transfusion sets for single use, gravity feed (ISO 1135-
4:2015)
Matériel de transfusion à usage médical - Partie 4: Transfusionsgeräte zur medizinischen Verwendung -
Appareils de transfusion non réutilisables à Teil 4: Transfusionsgeräte für
alimentation par gravité (ISO 1135-4:2015) Schwerkrafttransfusionen zur einmaligen Verwendung
(ISO 1135-4:2015)
This European Standard was approved by CEN on 24 July 2015.

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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2015 E
worldwide for CEN national Members.

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SIST EN ISO 1135-4:2016
EN ISO 1135-4:2015 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices . 5
2

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SIST EN ISO 1135-4:2016
EN ISO 1135-4:2015 (E)
European foreword
This document (EN ISO 1135-4:2015) 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
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.
Together with EN ISO 1135-5:2015 this document supersedes EN ISO 1135-4:2012.
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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, th
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