EN ISO 15747:2011

Plastic containers for intravenous injections (ISO 15747:2010)

ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2010 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2010)

Diese Internationale Norm legt Anforderungen zur sicheren Handhabung sowie die physikalische, chemische
und biologische Prüfung von Kunststoffbehältnissen für parenterale Injektionen fest.
Diese Internationale Norm gilt für Kunststoffbehältnisse für parenterale Injektionen mit einer oder mehreren
Kammern und einer Gesamt-Nennfüllmenge zwischen 50 ml und 5 000 ml, wie Beutel aus Folie oder durch
Spritzguss gefertigte Flaschen aus Kunststoff für Lösungen zur direkten Infusion (Injektion).

Récipients en plastique pour injections intraveineuses (ISO 15747:2010)

L'ISO 15747:2010 contient des exigences relatives à la manipulation sûre et aux essais physiques, chimiques et biologiques des récipients en plastique pour préparations parentérales.
L'ISO 15747:2010 s'applique aux récipients en plastique pour préparations parentérales, munis d'une ou de plusieurs chambres et ayant une capacité nominale totale comprise entre 50 ml et 5 000 ml, tels que les poches souples en feuille de polymère ou les flacons en plastique extrudé-soufflé pour l'administration directe en perfusion (injection) des solutions.

Plastični zbiralniki za intravenske injekcije (ISO 15747:2010)

ISO 15747:2010 vsebuje zahteve, povezane z varnim ravnanjem in fizikalnim, kemijskim in biološkim preskušanjem polimernih vsebnikov za parenteralne raztopine. ISO 15747:2010 velja za polimerne vsebnike za parenteralne raztopine z eno ali več komorami ter skupno nazivno kapaciteto v razponu med 50 ml in 5000 ml, kot so filmske vrečke ali pihane polimerne steklenice za neposredno dajanje raztopin za infundiranje (injiciranje).

General Information

• Status: Withdrawn
• Publication Date: 18-Oct-2011
• Withdrawal Date: 05-Mar-2019
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S03 - Syringes
• Drafting Committee: CEN/SS S03 - Syringes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 06-Mar-2019
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 15747:2012 - Plastic containers for intravenous injections (ISO 15747:2010)

Relations

• Replaces: EN ISO 15747:2010 - Plastic containers for intravenous injections (ISO 15747:2010)
• Effective Date: 08-Oct-2011
• Replaced By: EN ISO 15747:2019 - Plastic containers for intravenous injections (ISO 15747:2018)
• Effective Date: 13-Mar-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15747:2012
01-januar-2012
1DGRPHãþD
SIST EN ISO 15747:2010
3ODVWLþQL]ELUDOQLNL]DLQWUDYHQVNHLQMHNFLMH,62
Plastic containers for intravenous injections (ISO 15747:2010)
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2010)
Récipients en plastique pour injections intraveineuses (ISO 15747:2010)
Ta slovenski standard je istoveten z: EN ISO 15747:2011
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 15747:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15747:2012

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SIST EN ISO 15747:2012


EUROPEAN STANDARD
EN ISO 15747

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2011
ICS 11.040.20 Supersedes EN ISO 15747:2010
English Version
Plastic containers for intravenous injections (ISO 15747:2010)
Récipients en plastique pour injections intraveineuses (ISO Kunststoffbehältnisse für intravenöse Injektionen (ISO
15747:2010) 15747:2010)
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 15747:2011: E
worldwide for CEN national Members.

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SIST EN ISO 15747:2012
EN ISO 15747:2011 (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 15747:2012
EN ISO 15747:2011 (E)
Foreword
This document (EN ISO 15747:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection equipment for medical and pharmaceutical use".
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 15747:2010.
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, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15747:2010 has been approved by CEN as EN ISO 15747:2011 without any modification.
3

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SIST EN ISO 15747:2012
EN ISO 15747:2011 (E)
Annex ZA
(informative)

Relationship between this Europea
...