EN ISO 15747:2019
(Main)Plastic containers for intravenous injections (ISO 15747:2018)
Plastic containers for intravenous injections (ISO 15747:2018)
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document 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.
NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2018)
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).
In einigen Ländern sind nationale oder regionale Arzneibücher oder sonstige staatliche Vorschriften rechts¬verbindlich und deren Anforderungen haben Vorrang gegenüber dieser Internationalen Norm.
Récipients en plastique pour injections intraveineuses (ISO 15747:2018)
Le présent document spécifie les exigences relatives à la manipulation sûre et aux essais physiques, chimiques et biologiques des récipients en plastique pour préparations parentérales.
Le présent document s'applique aux récipients en plastique pour préparations parentérales, munis d'un ou de plusieurs compartiments 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.
NOTE Dans certains pays, la pharmacopée nationale ou régionale ou autres réglementations gouvernementales ont force de loi et ces exigences ont priorité sur le présent document.
Plastični zbiralniki za intravenske injekcije (ISO 15747:2018)
Ta dokument določa zahteve za varno ravnanje ter fizično, kemično in biološko
preskušanje plastičnih zbiralnikov za parenteralne izdelke.
Ta dokument se uporablja za plastične zbiralnike za parenteralne izdelke z enim ali več predelki in
skupno nazivno prostornino v razponu od 50 ml do 5000 ml, kot so vrečke iz folije ali pihane
plastenke za neposredno apliciranje infuzijskih (injekcijskih) raztopin.
OPOMBA: V nekaterih državah so nacionalne ali regionalne farmakopeje in drugi vladni predpisi zakonsko
zavezujoči ter imajo te zahteve prednost pred tem dokumentom.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2019
1DGRPHãþD
SIST EN ISO 15747:2012
3ODVWLþQL]ELUDOQLNL]DLQWUDYHQVNHLQMHNFLMH ,62
Plastic containers for intravenous injections (ISO 15747:2018)
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2018)
Récipients en plastique pour injections intraveineuses (ISO 15747:2018)
Ta slovenski standard je istoveten z: EN ISO 15747:2019
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.
EN ISO 15747
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 15747:2011
English Version
Plastic containers for intravenous injections (ISO
15747:2018)
Récipients en plastique pour injections intraveineuses Kunststoffbehältnisse für intravenöse Injektionen (ISO
(ISO 15747:2018) 15747:2018)
This European Standard was approved by CEN on 28 February 2019.
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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15747:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
European foreword
This document (EN ISO 15747:2019) 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 CCMC.
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 2019, and conflicting national standards
shall be withdrawn at the latest by September 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15747:2011.
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 the relationship with EU Directive(s) see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA”, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated ISO or
IEC standard, as listed below.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between normative references and dated EN and ISO standards
Equivalent dated standard
Normative references as listed in
Clause 2 of the ISO standard
EN ISO or IEC
ISO 2768-1 — ISO 2768-1:1989
ISO 2768-2 — ISO 2768-2:1989
ISO 8536-4 EN ISO 8536-4:2013 + ISO 8536-4:2010 +
A1:2013 Amd 1:2013
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-5 EN ISO 10993-5:2009 ISO 10993-5:2009
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15747:2018 has been approved by CEN as EN ISO 15747:2019 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission's standardization request [M/295
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169]
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”,
“minimized” or “removed”, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/subclause(s) of this
Remarks/Notes
Directive 93/42/EEC EN
7.2 4.1.6, 4.2 The part of ER 7.2 relating to
packaging is not addressed.
4.1.6 covers ER 7.2 only in
respect of particulate
contamination.
4.2 covers ER 7.2 only in respect
of the substances specified in the
Standard.
7.3 4.1.5, 4.2 Only the first half sentence of ER
7.3 is addressed.
4.1.5 covers ER 7.3 first part only
in respect of water permeability.
4.2 covers ER 7.3 first part only
in respect of the substances
specified in the Standard.
7.5 4.1.5, 4.2, 4.3.2 Only the first sentence of ER 7.5
is covered.
4.1.5 covers ER 7.5 first
sentence, first paragraph only in
respect of water permeability.
4.2 covers ER 7.5 first sentence,
first paragraph only in respect of
the substances specified in the
Standard.
4.3.2 covers ER 7.5 first
sentence, first paragraph only in
respect of the substances that
may have a pyrogenic effect.
7.6 4.1.7, 4.3.1 4.1.7 covers ER 7.6 only in
respect of preventing the ingress
of substances to the access port.
8.1 4.1.7 to 4.1.10, 4.3.1 4.1.7 covers ER 8.1 only in
respect of preventing the ingress
of substances to the access port.
4.3.1 covers ER 8.1 only in
respect of impermeability for
microorganisms into the
infusion container.
9.1 4.1.7 to 4.1.11 Restrictions indicated on the
label or in the instructions for
use are not addressed.
4.1.7 covers ER 9.1 only in
respect of the access port cover.
4.1.11 covers ER 9.1 only in
respect of the suspension hanger
and only if the hanger is not an
integral part of the device.
12.7.1 4.1.2, 4.1.3 Only resistance to mechanical
stress is addressed.
4.1.2 covers ER 12.7.1 only in
respect of temperature and
pressure tolerance.
4.1.3 covers ER 12.7.1 in respect
of resistance to damage by being
dropped.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to the European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 15747
Third edition
2018-09
Plastic containers for intravenous
injections
Récipients en plastique pour injections intraveineuses
Reference number
ISO 15747:2018(E)
©
ISO 2018
ISO 15747:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 15747:2018(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Physical requirements . 2
4.1.1 Manufacturing process compatibility . 3
4.1.2 Resistance to temperature, pressure and leakage . 3
4.1.3 Resistance to dropping . 3
4.1.4 Transparency . 3
4.1.5 Water vapour permeability . 3
4.1.6 Particulate contamination . 3
4.1.7 Cover. 3
4.1.8 Access port — Penetration ability of the insertion point . 3
4.1.9 Access port — Adhesion strength of the infusion device and
impermeability of the insertion point . 3
4.1.10 Access port — Tightness of the injection point . 4
4.1.11 Hanger.
...
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