EN ISO 15747:2010

SLOVENSKI STANDARD
01-junij-2010
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SIST EN ISO 15747:2005
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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 15747:2010
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
April 2010
ICS 11.040.20 Supersedes EN ISO 15747:2005
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 22 March 2010.

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 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 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15747:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

Foreword
This document (EN ISO 15747:2010) 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 October 2010, and conflicting national standards shall be withdrawn at
the latest by October 2010.
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 15747:2005.
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 a EN ISO 15747:2010 without any modification.
Annex ZA
(informative)
Relationship between this International Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
This International 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 International Standard and Directive 93/42/EEC on
medical devices
Clause/subclause(s) of this Essential Requirements (ERs) of Qualifying remarks
International Standard Directive 93/42/EEC
4.1 1, 2, 3, 4, 5, 6, 10, 12.8
4.1.2 7.3, 7.5, 12.7.1
4.1.3 7.1, 12.7.1
4.1.4 7.3
4.1.5 7.3, 7.5
4.1.6 7.2
4.1.7 to 4.1.10 7.6, 8.1, 9.1, 9.2
4.2 7.1, 7.2, 7.3, 7.5, 7.6
4.3.1 7.6, 8.1
4.3.2 7.1, 7.5 The part of ER 7.5 relating to
substances which are
carcinogenic, mutagenic or toxic to
reproduction as well as substances
that contain phthalates is not
specifically addressed in the
clause or in the corresponding
normative Annexes B and C.
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 tampered with
NOTE The cover can also envelop the entire container (e.g. outer bag).
3.3
empty container
raw container with identification, which is suitable for the acce
...