SIST EN ISO 15747:2010

Plastic containers for intravenous injections (ISO 15747:2010)

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.

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 � la manipulation s�re et aux essais physiques, chimiques et biologiques des r�cipients en plastique pour pr�parations parent�rales.
L'ISO 15747:2010 s'applique aux r�cipients en plastique pour pr�parations parent�rales, munis d'une ou de plusieurs chambres et ayant une capacit� nominale totale comprise entre 50 ml et 5 000 ml, tels que les poches souples en feuille de polym�re ou les flacons en plastique extrud�-souffl� pour l'administration directe en perfusion (injection) des solutions.

Plastični zbiralniki za intravenske injekcije (ISO 15747:2010)

Ta mednarodni standard vsebuje zahteve, povezane z varnim ravnanjem in fizikalnim, kemijskim in biološkim preskušanjem polimernih vsebnikov za parenteralne raztopine. Ta mednarodni standard velja za polimerne vsebnike za parenteralne raztopine z eno ali več komorami ter skupno nazivno kapaciteto v razponu med 50 ml in 5 000 ml, kot so filmske vrečke ali pihane polimerne steklenice za neposredno dajanje raztopin za infundiranje (injiciranje).

General Information

• Status: Withdrawn
• Public Enquiry End Date: 09-Aug-2008
• Publication Date: 06-May-2010
• Withdrawal Date: 05-Dec-2011
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 05-Dec-2011
• Due Date: 28-Dec-2011
• Completion Date: 06-Dec-2011
• 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: EN ISO 15747:2010 - Plastic containers for intravenous injections (ISO 15747:2010)

Relations

• Replaced By: SIST EN ISO 15747:2012 - Plastic containers for intravenous injections (ISO 15747:2010)
• Effective Date: 01-Jan-2012
• Replaced By: SIST EN ISO 15747:2012 - Plastic containers for intravenous injections (ISO 15747:2010)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 15747:2005 - Plastics containers for intravenous injection (ISO 15747:2003)
• Effective Date: 01-Jun-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15747:2010
01-junij-2010
1DGRPHãþD
SIST EN ISO 15747:2005
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 15747:2010
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 15747:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15747:2010

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SIST EN ISO 15747:2010


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.

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SIST EN ISO 15747:2010
EN ISO 15747:2010 (E)
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

2

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SIST EN ISO 15747:2010
EN ISO 15747:2010 (E)
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.
3

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SIST EN ISO 15747:2010
EN ISO 15747:2010 (E)
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.
4

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SIST EN ISO 15747:2010

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

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SIST EN ISO 15747:2010
ISO 15747:2010(E)
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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Published in Switzerland

ii © ISO 2010 – All rights reserved

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SIST EN ISO 15747:2010
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 2010 – All rights reserved iii

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SIST EN ISO 15747:2010
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

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SIST EN ISO 15747:2010
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.

© ISO 2010 – All rights reserved v

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SIST EN ISO 15747:2010

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SIST EN ISO 15747:2010
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 acceptance, storage and administration of the
injection solution
3.4
hanger
that part of the container that is used to hang it up
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SIST EN ISO 15747:2010
ISO 15747:2010(E)
3.5
identification
paper or foil label or printing or embossing
3.6
infusion container
container filled to its nominal capacity with parenteral injection product and with identification for the storage
and administration of the parenteral injection product
3.7
injection point
point for injecting pharmaceuticals
NOTE 1 The injection point and the insertion point can be identical.
NOTE 2 Some containers intentionally do not have an injection point.
3.8
insertion point
point which accepts the insertion part of the infusion device
3.9
nominal capacity
intended or declared fluid volume of a container
3.10
raw container
empty container that has not yet been sterilized and has no identification
3.11
sheeting
plastic film, foil or sheeting intended for the production of empty containers
4 Requirements
4.1 Physical requirements
4.1.1 Manufacturing process compatibility
The infusion container shall comply with the requirements given in 4.1.2 to 4.1.5 and 4.1.7 to 4.1.10 after the
manufacturing process (such as sterilization).
4.1.2 Resistance to temperature, pressure and leakage
The infusion container shall withstand alternating thermal stress, shall be resistant to pressure and shall be
leak-free when tested as specified in A.3.
4.1.3 Resistance to dropping
The infusion container shall sustain no damage after being dropped when tested as specified in A.4.
4.1.4 Transparency
The infusion container shall be sufficiently transparent so that suspended particles, turbidity and discoloration
can be recognised when tested as specified in A.5. Alternative procedures may be used.
NOTE Blocking of UV radiation should be considered depending on the content of the container.
2 © ISO 2010 – All rights reserved

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SIST EN ISO 15747:2010
ISO 15747:2010(E)
4.1.5 Water vapour permeability
Unless otherwise defined for specific applications or uses, the packed infusion container shall not lose more
than 5 % of its mass during the period of usability, when tested as specified in A.6.
NOTE Permeability of other gases (e.g. oxygen) should be taken into account depending on the content of the
container.
4.1.6 Particulate contamination
Infusion containers shall be manufactured so that contamination with particles is avoided.
When empty infusion containers are tested as specified in A.7, no more than 25 particles with a diameter
W 10 µm and no more than 3 particles with a diameter W 25 µm shall be found per millilitre of nominal capacity.
Finished parenteral solutions in the infusion containers shall comply with relevant pharmacopoeial
requirements for finished product particulate matter.
4.1.7 Cover
The access port shall be protected by a cover. Its intactness is determined by visual inspection. It shall be
possible to remove the cover without using mechanical aids.
4.1.8 Access port
It shall be possible to pierce the insertion point with the insertion part of an infusion device as specified in
−1
ISO 8536-4. The force shall not exceed 200 N at an insertion rate of 500 mm·min , when tested as specified
in A.8.
4.1.9 Adhesion strength of the infusion device and impermeability of the insertion point
The material and design of the access port shall be suitable for accepting the insertion part of an infusion
device in accordance with ISO 8536-4, for sealing off the insertion point and for holding the insertion part
firmly when subject to tensile load. When tested as specified in A.9 no leakage shall occur and the insertion
part shall not slide out from the insertion point. The removal force shall be greater than 15 N.
4.1.10 Injection point
If the container has an injection point, this shall not leak after puncturing and removal of the cannula when
tested as specified in A.10.
4.1.11 Hanger
It shall be possible to hang the infusion container up when it is in use. The hanger shall withstand a tensile
load when tested as specified in A.11.
4.1.12 Identification
The identification characters shall be clearly legible, and affixed labels shall not become detached when
tested as specified in A.12.
4.2 Chemical requirements
4.2.1 Requirements for the raw container or the sheeting
The sheeting shall fulfil the requirements given in the relevant pharmacopoeias. Alternatively, it may be tested
as described in Table 1.
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SIST EN ISO 15747:2010
ISO 15747:2010(E)
Tabl
...