EN ISO 15747:2005

Plastics containers for intravenous injection (ISO 15747:2003)

This International Standard contains requirements related 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 from to , such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
50 ml 5 000 ml

Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2003)

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 15747:2003)

Plastični zbiralniki za intravenske injekcije (ISO 15747:2003)

General Information

• Status: Withdrawn
• Publication Date: 29-Jun-2005
• Withdrawal Date: 14-Apr-2010
• 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
• Start Date: 15-Apr-2010
• Completion Date: 15-Apr-2010
• 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 15747:2005 - Plastics containers for intravenous injection (ISO 15747:2003)

Relations

• Replaced By: EN ISO 15747:2010 - Plastic containers for intravenous injections (ISO 15747:2010)
• Effective Date: 17-Apr-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15747:2005
01-junij-2005
3ODVWLþQL]ELUDOQLNL]DLQWUDYHQVNHLQMHNFLMH,62
Plastics containers for intravenous injection (ISO 15747:2003)
Kunststoffbehältnisse für intravenöse Injektionen (ISO 15747:2003)
Récipients en plastique pour injections intraveineuses (ISO 15747:2003)
Ta slovenski standard je istoveten z: EN ISO 15747:2005
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 15747:2005 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL ISO
STANDARD 15747
First edition
2003-11-15
Plastics containers for intravenous
injection
Récipients en plastique pour injections intraveineuses
Reference number
ISO 15747:2003(E)
ISO 2003
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ISO 15747:2003(E)
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© ISO 2003

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Published in Switzerland
ii ISO 2003 – All rights reserved
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ISO 15747:2003(E)
Contents Page

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 ........................................................................................................................................ 4

6 Application of tests ............................................................................................................................. 4

Annex A (normative) Physical tests ........................................................................................................... 6

Annex B (normative) Chemical tests .......................................................................................................... 9

Annex C (normative) Biological tests ....................................................................................................... 12

Annex D (informative) Further biological tests ........................................................................................ 15

Bibliography ............................................................................................................................................... 16

ISO 2003 – All rights reserved iii
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ISO 15747:2003(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.
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ISO 15747:2003(E)
Introduction

In some countries, national or regional pharmacopoeia or other government regulations are legally binding and

their requirements take precedence over this International Standard.
ISO 2003 – All rights reserved v
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INTERNATIONAL STANDARD ISO 15747:2003(E)
Plastics containers for intravenous injection
1Scope

This International Standard contains requirements related 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 from 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 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

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 which protects the access port during storage and also provides evidence if 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 which is used to hang it up
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
ISO 2003 – All rights reserved 1
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ISO 15747:2003(E)
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 recognized when tested as specified in A.5.
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.

4.1.6 Particulate contamination

Infusion containers shall be manufactured so that contamination with particles is avoided.

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ISO 15747:2003(E)

When empty infusion containers are tested as specified in A.7, no more than 20 particles with a diameter

� 5,0µm 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

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 up the infusion container 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.
Table 1
Maximum permissible
Requirements Test as specified in
value
Residue on ignition: B.2
Polyolefins 5 mg/g
Polyvinyl chloride
1 mg/g
containing plasticizers
Metals: Ba, Cd, Cr, Cu, Pb, Sn for each metal, 3 mg/kg B.3
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ISO 15747:2003(E)
4.2.2 Requirements for the test fluid

The test fluid shall be prepared as specified in B.4. No coloration, but weak opalescence of the test fluid is

permissible. It shall fulfil the requirements specified in Table 2.
Table 2
Requirements Maximum permissible value Testing as specified in
Acidity or alkalinity 0,4 ml sodium hydroxide solution B.6
[]c(NaOH)= 0,01 mol/l
0,8 ml hydrochloric acid
[]c(HCl)= 0,01 mol/l
UV absorbance in the range from 230 nm to 360 nm B.7
� 0,25 for infusion containers with a nominal
capacity � 100 ml
� 0,2 for infusion containers with a nominal
capacity > 100 ml
Evaporation residue 5 mg or 50 mg/l B.8
Oxidizable constituents 1,5 ml B.9
Ammonia 0,8 mg/l B.10
Metals: B.11
Ba, Cr, Cu, Pb for each metal, 1 mg/l
Sn, Cd for each metal, 0,1 mg/l
Al 0,05 mg/l
Heavy metals 2 mg/l B.12
4.3 Biological requirements
4.3.1 Impermeability to microorganisms

The infusion container shall be impermeable to microorganisms when tested as specified in C.2.

4.3.2 Migration/tolerance

The materials used for the manufacture of infusion containers (e.g. films, wrappings, adhesives, adhesion

promoters, printing inks) shall not release to the infusion solution any substances in such quantities that they

have a pyrogenic or toxic effect when tested as specified in C.3 and C.4.
5 Identification
Identification shall be in accordance with the relevant laws and specifications.
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ISO 15747:2003(E)
6 Application of tests

A distinction is made between type testing and batch testing. All tests specified in Annexes A to D are type

testing. They shall be repeated if one or more of the following conditions are changed significantly so that the

requirements as specified in Clause 4 might be affected:
— the design;
— the plastic composition;
— the process of manufacturing the infusion container;
— the sterilization process.
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ISO 15747:2003(E)
Annex A
(normative)
Physical tests
A.1 General

Physical testing shall be performed using an infusion container filled to its nominal capacity with infusion

solution or with water.
A.2 Sampling

Take samples required for the tests specified in A.3 to A.12 in accordance with the requirements of statistical

quality control for sampling for the type test, e.g. according to ISO 2859-1.
A.3 Resistance to temperature stability, pressure and leakage
◦ ◦

Store infusion containers for 24 h at (−25± 5)C2 and subsequently for 4h at (50± 5) C, and then subject

them to an internal pressure of 50 kPa between two plane parallel plates at (23± 5) C. Maintain this pressure

for 15 min. An equivalent test method may be used in which an external pressure device, such as a pressure

cuff, is applied to the bag in order to generate an equivalent internal pressure.

The test is passed if no leakage can be determined on visual inspection. The test does not apply to the internal

seals separating chambers within a container.
For infusion containers labelled “protect from freezing”, omit storage at −25 C.
A.4 Resistance to dropping

Drop infusion containers on a hard, rigid, smooth surface at a temperature of . Determine the

(23± 5) C

height of drop in accordance with Table A.1, depending upon the nominal capacity of the infusion container.

Table A.1
Nominal capacity Height of drop
ml m
50 to 749 1,00
750 to 1 499 0,75
1 500 to 2 499 0,5
2 500 and above 0,25

The test is passed if no infusion container is broken and no leakage can be determined on visual inspection.

A.5 Transparency
Prepare a stem suspension as follows.
a) Dissolve 6,0 g hydrazine sulfate for analysis in 400 ml clear water.
b) Dissolve 60,0 g hexamethylenetetramine for analysis in 400 ml clear water.

c) Pour the two solutions consecutively into a 1l measuring flask and fill to 1l with clear water.

d) Leave the solution to stand for 48 h at (20± 2) C so that a formazine suspension can develop.

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ISO 15747:2003(E)

Fill an empty infusion container to nominal capacity with stem suspension prepared as in a) to d) above, diluted

1:100, and fill an additional empty infusion container with clear water. In the case of infusion containers which

have been sterilized, allow them to remain undisturbed for 3h prior to inspection.

The test is passed if, on visual inspection, the turbidity of the formazine suspension in comparison with water is

clearly detectable against a black, dull-finished background. Conduct the inspection at an illumination intensity

in the range from 8 000 lx to 10 000 lx provided by incandescent light sources directly above and below the

container which illuminate the container at an angle of approximately 90 to the axis of observation. The light

sources shall illuminate the infusion container directly, i.e. be shielded from the analyst's eyes.

A.6 Water vapour permeability

Store infusion containers in final packaging at (25± 2) C, with a relative humidity of (40± 5) %, and without

exposure to direct light.

Unless otherwise defined for specific applications or uses, the test is passed if the rate of decrease in mass for

each individual infusion container does not exceed 5% during the period of usability. Suitable methods for

shortening the testing duration are permissible (e.g. accele
...