EN ISO 3826-1:2003

SLOVENSKI STANDARD
01-februar-2004
3ODVWLþQL]ORåOMLYLYVHEQLNL]DþORYHãNRNULLQNUYQHNRPSRQHQWH±GHO2ELþDMQL
YVHEQLNL,62
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO 3826-1:2003)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle
Beutel (ISO 3826-1:2003)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles (ISO 3826-1:2003)
Ta slovenski standard je istoveten z: EN ISO 3826-1:2003
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 3826-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2003
ICS 11.040.20
English version
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers (ISO 3826-
1:2003)
Poches en plastique souple pour le sang et les composants Kunststoffbeutel für menschliches Blut und Blutbestandteile
du sang - Partie 1: Poches conventionnelles (ISO 3826- - Teil 1: Konventionelle Beutel (ISO 3826-1:2003)
1:2003)
This European Standard was approved by CEN on 14 November 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-1:2003 E
worldwide for CEN national Members.

CORRECTED 2003-12-17
Foreword
This document (EN ISO 3826-1:2003) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection equipment for medical and pharmaceutical use" in
collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the
secretariat of which is held by BSI.
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 May 2004, and conflicting national standards
shall be withdrawn at the latest by May 2004.
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 relationship with EU Directive(s), see informative Annex ZB, 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, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 3826-1:2003 has been approved by CEN as EN ISO 3826-1:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 3696 1987 Water for analytical laboratory EN ISO 3696 1995
use - Specification and test
methods
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93 /42 / EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission to provide a means of conforming to Essential Requirements of the New Approach
Directive (European Directive 93 / 42 / EEC)
Once this standard is cited in the Official Journal of the European Communities 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 ZB 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 ZB — Correspondence between this European Standard and Directive
(European Directive 93 / 42 / EEC)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
6 Clauses 1 to 6
6.1 Clauses 7 to 13 Clause 7.1
For formulation of the plastic
material reference is given to
National Pharmacopeia.
No reference is given to the
flammability of the device.
6.2 Clauses 7 to 13
6.3 Clauses 7 to 13
6.4 Clauses 7 to 13
7 Clauses 7 to 13
8 Clauses 7 to 13
WARNING— Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
INTERNATIONAL ISO
STANDARD 3826-1
First edition
2003-11-15
Plastics collapsible containers for human
blood and blood components —
Part 1:
Conventional containers
Poches en plastique souple pour le sang et les composants du sang —
Partie 1: Poches conventionnelles

Reference number
ISO 3826-1:2003(E)
©
ISO 2003
ISO 3826-1:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 3826-1:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Dimensions and designation . 2
4.1 Dimensions. 2
4.2 Designation example. 2
5 Design. 2
5.1 General. 2
5.2 Air content. 2
5.3 Emptying under pressure. 2
5.4 Pilot samples. 2
5.5 Rate of collection . 2
5.6 Collection and transfer tube(s). 4
5.7 Blood-taking needle. 4
5.8 Outlet port(s). 4
5.9 Suspension. 5
6 Requirements. 5
6.1 General. 5
6.2 Physical requirements. 5
6.3 Chemical requirements. 7
6.4 Biological requirements. 8
7 Packaging. 8
8 Labelling. 9
8.1 General. 9
8.2 Label on plastics container. 9
8.3 Label on over-package . 9
8.4 Label on shipping box . 10
8.5 Label requirements. 10
9 Anticoagulant and/or preservative solution. 10
Annex A (normative) Chemical tests. 11
Annex B (normative) Physical tests . 16
Annex C (normative) Biological tests. 17
Bibliography . 20

ISO 3826-1:2003(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 3826-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This first edition of ISO 3826-1, together with other parts of ISO 3826 under preparation, cancels and replaces
ISO 3826:1993.
ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human
blood and blood components:
 Part 1: Conventional containers
The following part is under preparation:
 Part 2: Graphical symbols
iv © ISO 2003 — All rights reserved

ISO 3826-1:2003(E)
Introduction
In some countries national pharmacopoeias or other government regulations are legally binding and these
requirements take precedence over this part of ISO 3826.
The manufacturers of the plastics container, or the suppliers, are expected to disclose in confidence to the
national control authority, if requested by them, full details of the plastics material(s) and the components of
the materials and their methods of manufacture, details of manufacture of the plastics containers, including
the chemical names and quantities of any additives, whether incorporated by the manufacturer of the plastics
containers or present in the raw material, as well as full details of any additives that have been used.
Universal leucocyte depletion is mandatory in various countries. This part of ISO 3826 is considered a basic
document for future standards which include technical innovations, e.g. integrated leucocyte filters.
The requirements in this part of ISO 3826 are intended to
a) ensure that the quality of blood and blood components is maintained as high as necessary;
b) make possible efficient and safe collection, identification, storage, separation and transfusion of the
contents, with special attention to reducing or minimizing the risks resulting from
 contamination, in particular microbiological contamination,
 air embolism,
 errors in identification of plastics containers and any representative samples of contents,
 interaction between the plastics container and its contents;
c) ensure functional compatibility when used in combination with transfusion sets as specified in
ISO 1135-4;
d) provide appropriate resistance to breakage and deterioration in a package of minimal mass and volume.

INTERNATIONAL STANDARD ISO 3826-1:2003(E)

Plastics collapsible containers for human blood and blood
components —
Part 1:
Conventional containers
1 Scope
This part of ISO 3826 specifies requirements, including performance requirements, for plastics collapsible,
non-vented, sterile containers complete with collecting tube outlet port(s), integral needle and with optional
transfer tube(s), for the collection, storage, processing, transport, separation and administration of blood and
blood components. The plastics containers may contain anticoagulant and/or preservative solutions,
depending on the application envisaged.
This part of ISO 3826 is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple
or multiple units.
Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastics container as
prepared ready for use.
This part of ISO 3826 is not applicable to plastics containers with an integrated filter.
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 1135-3:1986, Transfusion equipment for medical use — Part 3: Blood-taking set
ISO 1135-4:1998, Transfusion equipment for medical use — Part 4: Transfusion sets for single use
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
plastics container
container, of plastics material, complete with collecting tube and needle, port(s), anticoagulant and/or
preservative solutions and transfer tube(s) and associated container(s), where applicable
3.2
shelf-life
period between the date of sterilization and the expiry date after which the plastics container(s) should not be
used for the collection of blood
ISO 3826-1:2003(E)
4 Dimensions and designation
4.1 Dimensions
Figure 1 illustrates the components of a plastics container. The values of the dimensions shown in Figure 1
are binding and form part of the requirements of this part of ISO 3826; the dimensions given in Table 1 are for
guidance only.
4.2 Designation example
Plastics containers are designated using the descriptor words “Plastics container” followed by the number of
this part of ISO 3826, followed by the nominal capacity of the container, in millilitres. For example, the
designation of a plastics container with a nominal capacity of 500 ml in accordance with this part of ISO 3826
is
Plastics container ISO 3826-1 - 500
5 Design
5.1 General
The design and manufacture of the plastics container shall provide for the safe and convenient collection,
storage, processing, transport, separation and administration of whole blood and blood components. The
plastics container shall permit the collection of blood and the preparation of plasma or centrifuged or
resuspended cellular components with a minimal hazard of contamination by microorganisms. The plastics
container shall be functionally compatible with the transfusion set specified in ISO 1135-4. Its design shall also
ensure that it can be used in a centrifuge cup.
5.2 Air content
5.2.1 The total volume of air contained in the plastics container system divided by the number of containers
shall not exceed 15 ml.
5.2.2 When used in accordance with the manufacturer's instructions, the plastics container shall be capable
of being filled with blood without air being introduced.
5.3 Emptying under pressure
The plastics container, when filled with a volume of water at a temperature of (23 ± 5) °C equal to its nominal
capacity and connected to a transfusion set as specified in ISO 1135-4 inserted in an outlet port (see 5.8),
shall empty without leakage within 2 min when gradually squeezed between two plates to an internal pressure
of 50 kPa above atmospheric pressure.
5.4 Pilot samples
The plastics container shall be designed so that pilot samples of unmistakable identity can be collected for the
performance of appropriate laboratory tests without the closed system of the plastics container being
penetrated. This may be accomplished e.g. by using an unmistakable numbering system on the tubing.
5.5 Rate of collection
The plastics container shall be designed so that it is capable of being filled to its nominal capacity in less than
8 min when tested in accordance with B.2.
2 © ISO 2003 — All rights reserved

ISO 3826-1:2003(E)
Dimensions in millimetres
Key
1 protector 5 tube
2 transfer tube, including means of closure (optional) 6 label area
3 outlet port 7 protective cap
4 eyelets 8 blood-taking needle
a
Length W 200 mm, internal diameter W 2,7 mm, wall thickness W 0,5 mm.
b
Length W 800 mm if used for gravitational collection.
See Table 1 for explanation of symbols.
Figure 1 — Schematic representation of plastics container
ISO 3826-1:2003(E)
Table 1 — Recommended dimensions for plastics containers, label areas and nominal capacity
Dimensions in millimetres
Inside width Inside height Size of label area
Nominal capacity
b h
ml b ± 5 h ± 5
1 1
2 2
100 75 120 60 85
250 120 130 90 85
400 120 170 105 105
500 120 185 105 105
5.6 Collection and transfer tube(s)
5.6.1 The plastics container may be provided with one or more collection or transfer tube(s) to allow the
collection and separation of blood and blood components.
If a transfer tube is present, it shall be fitted with a device which first acts as a seal and then, when broken,
permits the free flow of blood components in either direction.
5.6.2 The tubes shall be such that they can be sealed hermetically and do not collapse under normal use.
5.6.3 The plastics container, filled with water to its nominal capacity and sealed, and the tubes connected
to the plastics container, shall form a hermetic seal and a tight leakproof joint (see Note in 6.2.7) which will
withstand, without leakage occurring, a tensile force of 20 N applied to the tubing for 15 s. The tensile force
shall be applied at right angles to the edge of the joint and along the longitudinal axis of the plane of the
plastics container at a temperature of (23 ± 5) °C.
There shall be no leakage at the junctions and the plastics container shall also conform to the requirements
specified in 6.2.7.
5.6.4 Under visual inspection, the tubing shall not display cracks, blisters, kinks or other defects.
5.7 Blood-taking needle
The blood-taking needle shall be integral with the collection tube and covered by a protective cap. The
protective cap shall prevent leakage of anticoagulant and/or preservative solution from the plastics container
during storage, shall maintain the sterility of the fluid path and shall be readily removable. The protective cap
shall be tamper-evident and manufactured so that either it is impossible to replace or any attempt at
manipulating it is blatantly obvious.
The blood-taking needle, as specified in ISO 1135-3, shall withstand, without working loose from the assembly,
a tensile force of 20 N applied along the longitudinal axis of the tubing for 15 s.
The blood-taking needle may contain an anti-needle-stick device.
5.8 Outlet port(s)
5.8.1 The plastics container shall be provided with one or more outlet ports for the administration of blood
and blood components through a transfusion set. The port(s), which shall have a puncturable non-resealable
closure, shall allow connection of a transfusion set having a closure-piercing device in accordance with
ISO 1135-4 without leakage on insertion or during conditions of use, including emptying under pressure
(see 5.3). Before the closure is pierced by the point of the closure-piercing device, the outlet port(s) shall be
tightly occluded by the closure-piercing device. When used in accordance with manufacturer's instructions, the
piercing device shall not damage the plastic film of the plastics container on insertion.
NOTE For the dimensions of the closure-piercing device, see ISO 1135-4.
4 © ISO 2003 — All rights reserved

ISO 3826-1:2003(E)
5.8.2 Each outlet port shall be fitted with a hermetically sealed, tamper-evident protector to maintain the
sterility of the internal surface.
5.9 Suspension
The plastics container shall have adequate means of suspension or positioning (see for example eyelets in
Figure 1) which do not interfere with use of the plastics container during collection, storage, processing,
transport and administration. The means of suspending or positioning the container shall be capable of
withstanding a tensile force of 20 N applied along the longitudinal axis of the outlet port(s) for 60 min at a
temperature of (23 ± 5) °C without breaking.
6 Requirements
6.1 General
The plastics container shall be transparent, virtually colourless (see 6.2.4), flexible, sterile, non-pyrogenic, free
from toxicity (see 6.4) and non-frangible under conditions of use (see 6.2.5). It shall be compatible with the
contents under normal conditions of storage. The plastics container shall meet the requirements for terminal
sterilization, and shall not become tacky during sterilization and storage for its shelf-life at temperatures not
exceeding 40 °C.
The plastics container shall be stable biologically, chemically and physically with respect to its contents during
its shelf-life, and shall not permit penetration of microorganisms. Any substances leached from the plastics
container by the contained anticoagulant and/or preservative solution, blood and blood components by either
chemical interaction or physical dissolution, shall be within the limits specified.
In many countries, national pharmacopoeias specify formulations of different plastics materials such as
flexible PVC with different plasticizers and other plastics materials, while government regulations or standards
may detail suitable tests for assessing chemical or physical interactions.
6.2 Physical requirements
6.2.1 Conditions of manufacture
All processes involved in the manufacture, assembly and storage of the plastics container shall be carried out
under clean and hygienic conditions in compliance with the appropriate national regulations, in accordance
with relevant legislation and international agreements. Every practicable precaution shall be taken at all
stages to reduce the risk of adventitious contamination by microorganisms or foreign matter.
6.2.2 Sterilization
6.2.2.1 The plastics container shall have been sterilized by autoclaving or any other validated method.
6.2.2.2 The method of sterilization used shall not adversely affect the materials or contents, nor cause
any loosening of joints and deterioration of welds in the plastics material nor any major alteration in the shape
of the plastics container.
6.2.2.3 The manufacturer shall be able to produce evidence acceptable to the national control authority of
the effectiveness of the sterilization process actually used. If required by the national control authority, positive
controls to check the effectiveness of sterilization shall be included in each sterilization lot.
6.2.3 Transparency
When tested as specified in B.1, the opalescence of the suspension shall be perceptible when viewed through
the plastics container as compared with a similar plastics container filled with water.
ISO 3826-1:2003(E)
6.2.4 Coloration
The material of the sterilized plastics container shall not be coloured to such an extent that assessment of the
colour of the blood is adversely affected.
6.2.5 Thermal stability
The plastics container, filled to half of its nominal capacity with water as specified in ISO 3696, shall withstand
a slow freezing to and storage at −80 °C for 24 h, subsequent immersion in water at (37 ± 2) °C for 60 min,
and returning to room temperature. The plastics container shall meet the requirements of 5.6.3, 5.9, 6.2.7 and
6.2.8. Plastics containers intended to be fast-frozen or irradiated shall be validated for those applications.
If a refrigerant solution is used, the plastics container may be enclosed in a protective bag to avoid direct
contact between the refrigerant solution and the plastics container.
6.2.6 Water vapour transmission
The plastics container, without an over-package, shall be filled to its nominal capacity with water as specified
in ISO 3696, sealed and labelled ready for use. The plastics container shall then be capable of being stored
for 42 days at a temperature of (4 ± 2) °C and a relative humidity of (55 ± 5) % without loss of a mass fraction
of more than 2 % of water from the solution.
NOTE The storage of certain blood components, such as platelet concentrates, may require specific gas exchange
rates for oxygen and carbon dioxide.
6.2.7 Resistance to leakage
When filled to nominal capacity with water as specified in ISO 3696 and sealed, the plastics container shall
not develop leaks under conditions of centrifugation at 5 000 g at 37 °C for 10 min. The plastics container is
then squeezed between two plates to an internal pressure equivalent to 50 kPa above atmospheric pressure
at (23 ± 5)°C for 10 min. No leakage is allowed on visual inspection.
For containers of flexible poly(vinyl chloride) (PVC), both tests should be repeated at 4 °C. Plastics containers
that are normally centrifuged without solution shall be subjected to the same centrifugation conditions as
noted above without solution. Following this, the plastics container shall withstand an internal pressure
equivalent to 50 kPa above atmospheric pressure after filling to nominal capacity.
NOTE When the plastics container is filled with anticoagulant solution, such as an ACD solution or other solutions
with similar pH, leakage can be detected by pressing the plastics container against sheets of blue litmus paper and
observing the development of pink spots on the paper. For solutions of other pH, the same method with an appropriate
indicator can be used. Alternative methods affording at least the same degree of sensitivity may be used.
6.2.8 Particulate contamination
Plastics containers shall be manufactured so that contamination with particles is avoided.
When tested as described in B.4, the fluid path within the plastics container should be free from visible
particles.
NOTE Work is in progress to establish a procedure to provide limits on numbers of particles and sizes. For the time
being, limits and test procedures given in pharmacopoeias, for example those specified in the European Pharmacopoeia
for parenteral solutions, might be used.
6 © ISO 2003 — All rights reserved

ISO 3826-1:2003(E)
6.3 Chemical requirements
6.3.1 Requirements for the raw container or sheeting
The sheeting shall fulfil the requirements given in the relevant pharmacopoeias. Alternatively, it may be tested
as described in Table 2.
Table 2 — Ignition residues for polyolefins and PVC
Maximum
Test Plastics material Test as specified in
permissible residue
Polyolefins 0,5 mg/g
Residue on ignition A.2
PVC
1 mg/g
containing plasticizers
6.3.2 Requirements for the test fluid
The limits specified in Table 3 shall not be exceeded when the appropriate tests are carried out on the extract
obtained in accordance with Annex A.
Table 3 — Chemical limits on extracts from plastics container
Characteristics Maximum permissible value Test method in
Oxidizable constituents 1,5 ml A.4.1
Ammonia 0,8 mg/l A.4.2
–
Chloride ions (Cl) 4 mg/l A.4.3
Metals: Ba, Cr, Cu, Pb For each metal: 1 mg/l A.4.4.1
Sn, Cd For each metal: 0,1 mg/l
Al 0,05 mg/l
Heavy metals 2 mg/l A.4.4.2
Acidity or alkalinity 0,4 ml sodium hydroxide solution, c(NaOH) = 0,01 mol/l, or A.4.5
0,8 ml hydrochloric acid, c(HCl) = 0,01 mol/l
Residue on evaporation 5 mg or 50 mg/l A.4.6
Opalescence Slightly opalescent, but not more pronounced than that of reference A.4.7
suspension
Coloration No coloration A.4.8
UV absorbance In the range of 230 nm to 360 nm A.4.9
0,25 for plastics containers with a nominal capacity u 100 ml and
0,2 for plastics containers with a nominal capacity > 100 ml
Extractable plasticizer, e.g. 15 mg/100 ml A.4.10
di(2-ethylhexyl) phthalate
a
(DEHP)
a
Only for flexible PVC containing DEHP.
Materials used in the manufacture of plastics containers for human blood and blood components should be
carefully chosen so as to minimize the risks arising from leaching of chemical constituents into the product.
Particular attention should be given to the toxicity of the materials used and the biological compatibility of the
plastics container with the product.
ISO 3826-1:2003(E)
NOTE National pharmacopoeias have monographs on plastic materials which specify the composition and limit of
different constituents, as well as limits of heavy metals such as Ba, Pb, Cd, Sn, Cr, and e.g. vinyl chloride monomers,
where applicable.
6.4 Biological requirements
6.4.1 General
The plastics container shall not adversely affect the therapeutic effectiveness of blood and blood components
and not release substances which may exhibit toxic, cytotoxic, bacteriostatic, bactericidal, pyrogenic or
haemolytic reactions.
NOTE Typical toxicity tests are given in the ISO 10993 series (see Bibliography).
In many countries, national pharmacopoeias, government regulations or standards detail suitable tests for
assessing biological safety. In addition to the tests specified in C.2 to C.5, the tests given in C.6 may be used
as guidance.
6.4.2 Impermeability for microorganisms
The plastics container shall be impermeable to microorganisms when tested as specified in C.2.
6.4.3 Compatibility
When tested as specified in C.3, C.4 and C.5, the plastics containers shall not release to the anti-
coagulant/preservation solution and/or blood or blood components any substances in such quantities that they
have a pyrogenic, toxic or haemolytic effect.
7 Packaging
7.1 The requirements in 7.2 to 7.6 are related to the plastics container in its sealed over-package.
7.2 The shelf-life (see 3.2) of the plastics container shall be established by the manufacturer on the basis of
stability data. When containing anticoagulant and/or preservative solution, the container shall have a shelf-life
not greater than the time during which the water loss from the container equals a mass fraction of 5 % at
defined storage conditions of temperature and humidity.
7.3 The materials of the overpackage or any treatment to its interior surface should neither interact with the
plastic of the container or its contents nor support mould growth. If chemical fungicides are used, evidence
shall be provided to show there has been no harmful penetration of, or effect on, the plastics container and its
contents.
7.4 The over-package shall be sealed in such a manner as to be tamper-evident and to prevent opening or
reclosing without displaying signs that the seal has been destroyed.
7.5 The over-package shall be strong enough to resist damage under conditions of normal handling and
use.
7.6 The plastics container and components shall be arranged in the over-package in a manner which will
minimize the collecting tube and connecting tube(s) [transfer tube(s)] from kinking and acquiring a permanent
set.
8 © ISO 2003 — All rights reserved

ISO 3826-1:2003(E)
8 Labelling
8.1 General
The labelling of a plastics container shall conform to applicable national regulations. In absence of national
regulations the labelling shall include the requirements as specified in 8.2 to 8.5. Graphical symbols as given
in ISO 15223 may be used.
8.2 Label on plastics container
The label shall, if possible, contain the information specified in a) to i). However, if the available label space is
too small for this purpose, it is permissible to give the information of items d), e), f) and g) in the instructions
for use rather than on the label:
a) description of the contents and intended use;
b) nature, formulation and volume (in millilitres) or mass (in grams) of anticoagulant and/or preservative
solution and any other material introduced, and the volume (in millilitres), or mass (in grams) of blood and
blood components to be collected;
c) a statement defining the conditions of sterility and non-pyrogenicity;
d) an instruction indicating not to use the plastics container if there is any visible sign of deterioration;
e) an instruction indicating not to vent;
f) an instruction that the container is for single use only;
g) a reference to the instructions for use of the plastics container;
h) manufacturer's name and address and/or the name and address of the supplier responsible;
i) lot designation.
If appropriate, the label can also contain information concerning the date after which the container should not
be used to collect blood, and concerning the manufacturer's product code.
8.3 Label on over-package
The over-package label shall contain the following information:
a) manufacturer's name and address and/or the name and address of the supplier responsible;
b) description of the contents;
c) expiry date;
1)
d) an instruction indicating that the plastics container shall not be used more than n days after removal
from the over-package;
e) lot designation.
If a transparent over-package is used, all the information required under 8.2 and 8.3 should appear on the
label of the plastics container.

1) If there are no applicable national regulations, n is determined by the manufacturer.
ISO 3826-1:2003(E)
8.4 Label on shipping box
The label, which should be visible when paletted, shall contain the following information:
a) manufacturer's name and address and/or the name and address of the supplier responsible;
b) description of the contents;
c) storage conditions;
d) lot designation;
e) expiry date;
f) if the transit container functions as an over-package, an instruction indicating that the plastics container
1)
shall not be used more than n days after removal from the over-package.
8.5 Label requirements
The label on the plastics container shall be such that
a) an appropriate label area is reserved for information related to the plastics container manufacturer and
user;
NOTE Usually, 30 % of the label area is intended for entries of the manufacturer and 70 % of the label area is
intended for entries or over-labelling of those who fill the plastics container with blood.
b) by leaving a portion of the plastics container visible and free of markings, the contents can be adequately
inspected visually;
c) there is no diffusion of the print from the label into the material of the plastics container;
d) the printing on the label remains legible at the time of use;
e) any adhesive used on the label shall not support mould growth, evidence shall be provided to show there
has been no harmful effect on the plastics container and its contents;
f) any attempt to peel off the label shall result in the label being destroyed.
g) When tested in accordance with B.3, the label(s) shall not separate from the plastics containers after
removal from water. Printing on the label or on the plastics container shall remain legible.
9 Anticoagulant and/or preservative solution
The quality of the anticoagulant and/or preservative solution, if any, shall satisfy the requirements of the
national pharmacopoeia and national regulations.
10 © ISO 2003 — All rights reserved

ISO 3826-1:2003(E)
Annex A
(normative)
Chemical tests
A.1 General
Take materials for testing from the blood and blood derivatives contact materials of the finished, empty and
sterilized plastics containers, i.e. in the state in which they would be used for transfusion, collection,
separation and administration procedures, including the plastic sheet used for the collecting bag and the
plastic tubings used for the collection tube, transfer tube and any parts that come into contact with blood and
blood components.
A.2 Determination of residue on ignition
Weigh 1,00 g to 2,00 g of the material (in small pieces) into a suitable crucible that has been previously ignited,
cooled and weighed. Heat to 100 °C to 105 °C for 1 h. Then ignite to (550 ± 25) °C. Allow to cool in a
desiccator and weigh. Repeat ignition until constant mass is attained. Calculate mass of residue on ignition
per gram of starting material.
Equivalent methods as described in pharmacopoeias may be used.
A.3 Preparation of the test fluid
Fill the empty container twice to the nominal capacity with water for injection, shake for approximately 1 min
and then empty. After the rinse water has drained off, fill the empty container to the nominal volume with water
for injection. Then compress the container so that the remaining air escapes from the container, and
subsequently close it. Extract the container for at least 30 min in pressurized, saturated steam at (121 ± 2) °C.
Use 250 ml water for injection as a comparative fluid (blank sample). Heating and cooling times are not
included in the 30 min cycle time requirement.
If appropriate, the extraction may be performed on pieces of sheeting or raw container. Use pieces with a total
surface area of 1500 cm which includes both sides of the plastic sheet. Wash this material twice with 100 ml
water for injection and discard the water after use. Drain the pieces, cover them with 250 ml water for injection
and extract for 30 min in pressurized, satura
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