EN ISO 15747:2011
(Main)Plastic containers for intravenous injections (ISO 15747:2010)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
Only chemical toxicity is
4.2, 4.3.2 7.1
addressed (in clause 4.2).
Only pyrogenic and toxic effects
are addressed (in clause 4.3.2).
4.1.4, 4.1.6, 4.2 7.2 The part of ER 7.2 regarding the
packaging is not addressed.
4.1.2, 4.1.5, 4.2 7.3 Only the first half sentence of ER
7.3 is addressed.
4.1.2, 4.1.5, 4.2, 4.3.2 7.5 Only the first sentence of ER 7.5
is covered.
4.1.7 to 4.1.10, 4.3.1 7.6
4.1.7 to 4.1.11, 4.3.1 8.1
4.1.7 to 4.1.11 9.1 Restrictions indicated on the
label or in the instructions for
use are not addressed.
4.1.2, 4.1.3 12.7.1 Only resistance to mechanical
stress is addressed.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 15747
Second edition
2010-04-15
Plastic containers for intravenous
injections
Récipients en plastique pour injections intraveineuses
Reference number
ISO 15747:2010(E)
©
ISO 2010
ISO 15747:2010(E)
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ii © ISO 2010 – All rights reserved
ISO 15747:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Requirements.2
4.1 Physical requirements .2
4.2 Chemical requirements.3
4.3 Biological requirements.4
5 Identification .5
6 Application of tests .5
Annex A (normative) Physical tests.6
Annex B (normative) Chemical tests .9
Annex C (normative) Biological tests .12
Bibliography.14
ISO 15747:2010(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15747 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 15747:2003), which has been technically
revised. Especially Annex C was totally revised in order to refer to the International Standards of the
ISO 10993 series, which specifies the biological assessment of medical products.
iv © ISO 2010 – All rights reserved
ISO 15747:2010(E)
Introduction
In some countries, national or regional pharmacopoeias or other government regulations are legally binding
and these requirements take precedence over this International Standard.
INTERNATIONAL STANDARD ISO 15747:2010(E)
Plastic containers for intravenous injections
1 Scope
This International Standard contains requirements that relate to the safe handling and the physical, chemical
and biological testing of plastic containers for parenterals.
This International Standard 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 10993 (all parts), Biological evaluation of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
access port
area of the infusion container consisting of the insertion point and the injection point, if applicable
3.2
cover
part that protects the access port during storage and also provides evidence that the infusion container has
been ta
...
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