EN ISO 3826-1:2013

SLOVENSKI STANDARD
01-september-2013
1DGRPHãþD
SIST EN ISO 3826-1:2004
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YVHEQLNL,62
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO 3826-1:2013)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle
Beutel (ISO 3826-1:2013)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles (ISO 3826-1:2013)
Ta slovenski standard je istoveten z: EN ISO 3826-1:2013
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
June 2013
ICS 11.040.20 Supersedes EN ISO 3826-1:2003
English Version
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers (ISO 3826-
1:2013)
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 3826-1:2013)
1:2013)
This European Standard was approved by CEN on 22 May 2013.

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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-1:2013: E
worldwide for CEN national Members.

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

Foreword
This document (EN ISO 3826-1:2013) 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 DIN.
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 December 2013, and conflicting national standards shall be withdrawn
at the latest by December 2013.
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 3826-1:2003.
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, 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 3826-1:2013 has been approved by CEN as EN ISO 3826-1:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
This European 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, Medical devices.
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 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 European Standard and Directive 93/42/EEC, Medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6.2.3, 6.2.8, 6.3, 7.5 7.2 Only the protection to the
patients is explicitly addressed.
The part of ER 7.2 regarding the
packaging is not fully addressed.
5.1 to 5.8, 6.2.5 to 6.2.8, 6.3 7.3 Only the first half sentence of ER
7.3 is addressed.
5.6.3, 6.2.6, 6.2.7, 6.3, 6.4.3, 8.1 7.5 (first and second paragraph) The part of ER 7.5 relating to
phthalates is not explicitly
covered.
5.7, 5.8, 6.4.2 7.6
5.7, 5.8, 6.2.2, 6.4.2 8.1 The part of ER 8.1 relating to
easy handling is not addressed.
6.2.2, 7.4, 7.5 8.3
6.2.2 8.4
6.2.1 8.5
5.8, 5.9 9.1 Restrictions indicated on the
label or in the instructions for
use are not addressed.
5.7, 5.8.1 9.2 (first indent)
5.6, 5.9, 6.2.7 12.7.1 Only resistance to mechanical
stress is addressed.
8.2 to 8.5 13.1
8.1 13.2
8.2 to 8.5 13.3 The part of ER 13.3 related to
authorized representative is not
addressed.
8.2 to 8.5 13.4
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
Second edition
2013-06-01
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 3826-1:2013(E)
©
ISO 2013
ISO 3826-1:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO 3826-1:2013(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 . 3
5.6 Collection and transfer tube(s) . 5
5.7 Blood-taking needle . . 5
5.8 Outlet port(s) . 6
5.9 Suspension . 6
6 Requirements . 6
6.1 General . 6
6.2 Physical requirements . 7
6.3 Chemical requirements. 8
6.4 Biological requirements . 9
7 Packaging .10
8 Labelling .10
8.1 General .10
8.2 Label on plastics container .10
8.3 Label on over-package .11
8.4 Label on shipping box .11
8.5 Label requirements .11
9 Anticoagulant and/or preservative solution .12
Annex A (normative) Chemical tests .13
Annex B (normative) Physical tests .18
Annex C (normative) Biological tests .20
Bibliography .23
ISO 3826-1:2013(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, and
blood processing equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 3826-1:2003), of which it constitutes a
minor revision with the following changes:
— Figure 1 on the schematic representation of plastics containers has been updated;
— Table 1 has been amended to include a plastics container with a nominal capacity of 600 ml;
— subclause 5.6.5 on requirements for sterile connection transfer tubing has been added;
— subclause 5.8.1 on the outlet port(s) has been amended by a specification for placement of the
septum and by a Note 2;
— subclauses 5.8.3 and 5.8.4 on further requirements for the outlet port(s) have been added;
— Clause B.5 on a test for sterile connection of tubing has been added;
— Annex C on biological tests has been completely revised and shortened in order to incorporate the
linkage to the ISO 10993 series;
— the Bibliography has been updated;
— minor editorial changes have been made throughout the whole document.
ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human
blood and blood components:
— Part 1: Conventional containers
— Part 2: Graphical symbols for use on labels and instruction leaflets
— Part 3: Blood bag systems with integrated features
The following parts are under preparation:
— Part 4: Aphaeresis blood bag systems with integrated features
iv © ISO 2013 – All rights reserved

ISO 3826-1:2013(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 other standards which include technical innovations.
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 a package with appropriate resistance to breakage and deterioration.
INTERNATIONAL STANDARD ISO 3826-1:2013(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 documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 1135-4:2012, Transfusion equipment for medical use — Part 4: Transfusion sets for single use
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
plastics container
bag, 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
ISO 3826-1:2013(E)
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
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 3826-1:2013, 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.
NOTE Typical plastics container systems are described in ISO 3826-3.
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 compatibility 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.
2 © ISO 2013 – All rights reserved

ISO 3826-1:2013(E)
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.
ISO 3826-1:2013(E)
Dimensions in millimetres
Key
1 tamper evident protector(s) 8 tamper evident protective cap
2 transfer tube 9 blood-taking needle
3 means of closure (optional) 10 needle hub
4 outlet port(s) 11 eyelets
5 collection tube 12 puncturable non-resealable closure(s)
6 tear line of protector 13 side slits
7 label area
a
Length ≥ 200 mm, internal diameter ≥ 2,7 mm, wall thickness ≥ 0,5 mm.
b
Length ≥ 800 mm if used for gravitational collection, internal diameter ≥ 2,7 mm, wall thickness ≥ 0,5 mm.
c
External view.
d
Cross-sectional view.
NOTE See Table 1 for explanation of dimensions.
Figure 1 — Schematic representation of plastics container
4 © ISO 2013 – All rights reserved

ISO 3826-1:2013(E)
Table 1 — Dimensions for plastics containers, label areas, and nominal capacity
Dimensions in millimetres
Size of label area
Nominal capacity Inside width Inside height
ml w h
1 1
w ± 5 h ± 5
2 2
100 75 120 60 85
250 120 130 90 85
400 120 170 105 105
500/600 120 185 105 105
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, and if necessary to avoid unexpected flow between containers, 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.
5.6.5 Requirements for sterile connection of transfer tubing: Tubing design shall allow the efficient
transfer of blood and blood components between packs. Design should also allow the joining of tubes
supplied by a single manufacturer or from different manufacturers using a sterile tube welding device.
Typically, this is to enable the connection of separate satellite packs when preparing blood components
by a ‘secondary process’. Sterile tube welding devices join the two opposing ends of the tube while
maintaining a sterile fluid pathway.
Manufacturers of sterile tube welding devices typically specify acceptable tube dimensions (external
and/or internal diameter and wall thickness) for use on their equipment. Blood bag manufacturers
must specify in their product documentation the material, internal and external diameters, and wall
thickness of all their tubing to allow blood transfusion services to assess the suitability for tube welding.
When a blood transfusion service wishes to weld tubing of different specifications, they should carry
out a validation before proceeding. A protocol is provided (see Clause B.5) as a minimum standard for
[5]
such validations (see also Reference ).
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.
ISO 3826-1:2013(E)
The internal and external surfaces of the blood-taking needle shall be clean and smooth. The bevel of the
needle shall be sharp and free from ridges, burrs, and barbs.
The joint between the blood-taking needle and the needle hub shall withstand a static tensile (pull)
force and compressive (push) force of 20 N for 15 s along the longitudinal axis.
The blood-taking needle may contain a needle-stick protection device in accordance with ISO 3826-3.
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 port septum placed (14 ± 2) mm from the top of the port, 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 1 For the dimensions of the closure-piercing device, see ISO 1135-4.
NOTE 2 When designing the outlet port to ensure good compatibility with closure-piercing devices,
manufacturers should avoid the use of tubing that is highly inflexible. Thin-walled tubing (<1 mm) should also be
avoided as this tends to twist and collapse on insertion.
5.8.2 Each outlet port shall be fitted with a hermetically sealed, tamper-evident protector to maintain
the sterility of the internal surface.
5.8.3 When a closure-piercing device conforming to ISO 1135-4 is inserted into the blood bag port, this
shall resist a pull force of 15 N for 15 s.
5.8.4 When tested in accordance with 5.3, the connection between the closure-piercing device and the
blood bag port shall show no evidence of leakage.
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 the 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, biologically safe (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.
6 © ISO 2013 – All rights reserved

ISO 3826-1:2013(E)
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
[3]
accordance with relevant legislation and international agreements, such as current GMP requirements.
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 steam sterilization 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.
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
This requirement refers primarily to plasma-freezing bags.
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 shock-frozen (blast-frozen) or irradiated
shall be validated for those specific 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
ISO 3826-1:2013(E)
being stored for 42 days at a temperature of (4 ± 2) °C 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 minimized.
When tested as described in B.4, the fluid path within the plastics container should be free from
visible particles.
NOTE 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.
6.3 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 as specified
Test Plastics material permissible
in
residue
Polyolefins 0,5 mg/g
PVC
Residue on ignition A.2
containing plasticiz- 1 mg/g
ers
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.
8 © ISO 2013 – All rights reserved

ISO 3826-1:2013(E)
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 refer- A.4.7
ence 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 ≤ 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 shall
be carefully chosen so as to minimize the risks arising from leaching of chemical constituents into
the product. Particular attention shall be given to the toxicity of the materials used and the biological
compatibility of the plastics container with the product.
NOTE National pharmacopoeias have monographs on plastic materials which specify the composition and
limit of different constituents, as well as limits of 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 undue toxic, cytotoxic, bacteriostatic,
bactericidal, pyrogenic, or haemolytic reactions.
Typical biological safety tests are given in the ISO 10993 series.
6.4.2 Impermeability for microorganisms
The plastics container shall be impermeable to microorganisms when tested as specified in C.3.
6.4.3 Compatibility
When tested as specified in C.4, C.5, and C.6, the plastics containers shall not release to the
anticoagulant/preservative solution and/or blood or blood components any substances in such
quantities that they have a pyrogenic, toxic, or haemolytic effect.
ISO 3826-1:2013(E)
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 over-package 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 transfer tube(s) from kinking and acquiring a permanent set.
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. If graphical
symbols are used, then refer to ISO 3826-2 and ISO 15223-1.
NOTE The European Medical Device Directive (93/42/EEC as amended by 2007/47/EC) requires labelling of
medical devices containing phthalates (see EN 15986).
8.2 Label on plastics container
The label shall, if possible and where applicable, 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
f), g) and h) in the instructions for use rather than on the label:
a) manufacturer’s name and address and/or the name and address of the supplier responsible;
b) description of the contents and intended use;
...