SIST 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• Status: Withdrawn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: 31-May-2005
• Withdrawal Date: 02-May-2010
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 03-May-2010
• Due Date: 26-May-2010
• Completion Date: 03-May-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: EN ISO 15747:2005 - Plastics containers for intravenous injection (ISO 15747:2003)

Relations

• Replaced By: SIST EN ISO 15747:2010 - Plastic containers for intravenous injections (ISO 15747:2010)
• Effective Date: 01-Jun-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)
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ISO 15747:2003(E)
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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
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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.
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.
vi

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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
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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
−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 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
...