SIST EN ISO 3826-1:2013
(Main)Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
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.
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2013)
Dieser Teil von ISO 3826 legt Anforderungen einschließlich der geforderten Leistungsmerkmale fest für nicht belüftete, sterile Kunststoffbeutel, die mit Entnahmeschlauch, einem oder mehreren Einstechstutzen, integrierter Blutentnahmekanüle und wahlweise mit Überleitungsschlauch oder schläuchen ausgestattet sind und die zur Aufnahme, Lagerung, Aufbereitung, zum Transport, zur Trennung und Verabreichung von Blut und Blutbestandteilen bestimmt sind. Die Kunststoffbeutel können, je nach vorgesehener Verwendung, Antikoagulans und/oder Stabilisatorlösung enthalten.
Dieser Teil von ISO 3826 ist auch anwendbar auf Mehrfachsysteme von Kunststoffbeuteln, die sich z. B. aus zwei, drei, vier oder mehr Einheiten zusammensetzen.
Soweit nichts anderes vorgegeben ist, gelten alle in diesem Teil von ISO 3826 festgelegten Prüfungen für den gebrauchsfertigen Kunststoffbeutel.
Dieser Teil von ISO 3826 gilt nicht für Kunststoffbeutel mit einem integrierten Filter.
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches conventionnelles (ISO 3826-1:2013)
L'ISO 3826-1:2013 spécifie les exigences, y compris les exigences de performance, des poches en plastique souple, sans prise d'air, stériles, présentées complètes avec tubulure de prélèvement à aiguille solidaire, raccord(s) de sortie, et, éventuellement, tubulure(s) de transfert, destinées au prélèvement, au stockage, au traitement, au transport, à la séparation et à la transfusion du sang et des composants du sang. Les poches en plastique peuvent contenir des solutions anticoagulantes et/ou de conservation, selon l'usage prévu.
Les exigences spécifiées dans l'ISO 3826-1:2013 sont également applicables aux poches en plastique multiples, par exemple les poches doubles, triples ou quadruples.
Sauf indication contraire, tous les essais spécifiés dans l'ISO 3826-1:2013 sont applicables aux poches en plastique prêtes à l'emploi.
L'ISO 3826-1:2013 n'est pas applicable aux poches en plastique comportant un filtre intégré.
Plastični zložljivi vsebniki za človeško kri in krvne komponente - 1. del: Običajni vsebniki (ISO 3826-1:2013)
Ta del standarda ISO 3826 določa posebne zahteve, vključno z zahtevami glede zmogljivosti, za plastične zložljive nezračene sterilne vsebnike z izhodnimi priključki zbirne cevke, vdelano iglo in dodatnimi prenosnimi cevkami za zbiranje, shranjevanje, obdelavo, transport, ločevanje in upravljanje krvi in krvnih komponent. Plastični vsebniki lahko vsebujejo antikoagulant in/ali konzervans, odvisno od predvidene uporabe. Ta del standarda ISO 3826 se uporablja tudi za enote z več plastičnimi vsebniki, npr. za dvojne, trojne, četverne ali večje enote. Razen če je navedeno drugače, vsi preskusi, navedeni v tem delu standarda ISO 3826, veljajo za plastične vsebnike, pripravljene za uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 3826-1:2013
01-september-2013
1DGRPHãþD
SIST EN ISO 3826-1:2004
3ODVWLþQL]ORåOMLYLYVHEQLNL]DþORYHãNRNULLQNUYQHNRPSRQHQWHGHO 2ELþDMQL
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
SIST EN ISO 3826-1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 3826-1:2013
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SIST EN ISO 3826-1:2013
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.
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SIST EN ISO 3826-1:2013
EN ISO 3826-1:2013 (E)
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
2
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SIST EN ISO 3826-1:2013
EN ISO 3826-1:2013 (E)
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.
3
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SIST EN ISO 3826-1:2013
EN ISO 3826-1:2013 (E)
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.
4
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SIST EN ISO 3826-1:2013
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
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SIST EN ISO 3826-1:2013
ISO 3826-1:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 3826-1:2013
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 2013 – All rights reserved iii
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SIST EN ISO 3826-1:2013
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
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SIST EN ISO 3826-1:2013
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.
© ISO 2013 – All rights reserved v
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SIST EN ISO 3826-1:2013
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SIST EN ISO 3826-1:2013
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 2013 – All rights reserved 1
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SIST EN ISO 3826-1:2013
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
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SIST EN ISO 3826-1:2013
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 2013 – All rights reserved 3
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SIST EN ISO 3826-1:2013
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
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SIST EN ISO 3826-1:2013
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 3826-1:2010
01-december-2010
3ODVWLþQL]ORåOMLYLYVHEQLNL]DþORYHãNRNULLQNUYQHNRPSRQHQWHGHO 2ELþDMQL
YVHEQLNL ,62',6
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO/DIS 3826-1:2010)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles (ISO/DIS 3826-1:2010)
Ta slovenski standard je istoveten z: prEN ISO 3826-1
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 3826-1:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 3826-1:2010
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oSIST prEN ISO 3826-1:2010
EUROPEAN STANDARD
DRAFT
prEN ISO 3826-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2010
ICS 11.040.20 Will supersede EN ISO 3826-1:2003
English Version
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers (ISO/DIS 3826-
1:2010)
Poches en plastique souple pour le sang et les composants
du sang - Partie 1: Poches conventionnelles (ISO/DIS
3826-1:2010)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 3826-1:2010: E
worldwide for CEN national Members.
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oSIST prEN ISO 3826-1:2010
prEN ISO 3826-1:2010 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 3826-1:2010
prEN ISO 3826-1:2010 (E)
Foreword
This document (prEN ISO 3826-1:2010) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 3826-1:2003.
Endorsement notice
The text of ISO/DIS 3826-1:2010 has been approved by CEN as a prEN ISO 3826-1:2010 without any
modification.
3
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oSIST prEN ISO 3826-1:2010
DRAFT INTERNATIONAL STANDARD ISO/DIS 3826-1
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2010-10-14 2011-03-14
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
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
[Revision of first edition (ISO 3826-1:2003)]
ICS 11.040.20
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©
International Organization for Standardization, 2010
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ISO/DIS 3826-1
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ii ISO 2010 – All rights reserved
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ISO/DIS 3826-1
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DRAFT 2010
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oSIST prEN ISO 3826-1:2010
ISO/DIS 3826-1
Contents Page
Foreword. v
Introduction . vi
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.3
5.5 Rate of collection.3
5.6 Collection and transfer tube(s).4
5.7 Blood-taking needle.5
5.8 Outlet port(s).5
5.9 Suspension.6
6 Requirements.6
6.1 General.6
6.2 Physical requirements.6
6.3 Chemical requirements.8
6.4 Biological requirements.9
7 Packaging.9
8 Labelling.10
8.1 General.10
8.2 Label on plastics container .10
8.3 Label on over-package.10
8.4 Label on shipping box.11
8.5 Label requirements.11
9 Anticoagulant and/or preservative solution .11
Annex A (normative) Chemical tests.12
Annex B (normative) Physical tests.17
Annex C (normative) Biological tests .19
Bibliography .22
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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 second edition cancels and replaces the first edition, which has been technically revised. Especially the
following changes have been made:
⎯ 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;
⎯ a new clause 5.6.5 on requirements for sterile connection transfer tubing has been added;
⎯ 5.7 on the blood-taking needle has been widely aligned with the relevant paragraph in ISO 1135-3;
⎯ 5.8 on the outlet port(s) has been updated regarding a good compatibility with closure piercing-devices in
accordance with ISO 1135-4;
⎯ a new 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 through 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
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ISO/DIS 3826-1
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.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 3826-1
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 1135-4:2010, 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 9626:1991/Amd.1:2010, Stainless steel needle tubing for the manufacture of medical devices;
Amendment 1
ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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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
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 - 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.
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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.
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.
Dimensions in millimetres
Key
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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 inlet port 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.
See Table 1 for explanation of dimensions.
Figure 1 — Schematic representation of plastics container
Table 1 — Dimensions for plastics containers, label areas and nominal capacity
Dimensions in millimetres
Inside width Inside height Size of label area
Nominal capacity
w h
ml w ± 5 h ± 5
1 1
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, 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 whilst 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
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ISO/DIS 3826-1
their product documentation, the material, internal and external diameter 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 (Annex B.5) as a minimum standard for such validations
(see also [11]).
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 not be less than 35 mm in length. The external
diameter shall be 1,6 mm (16 gauge) and the internal diameter shall not be less than 70 % of the external
diameter (see also ISO 9626:1991/Amd.1:2010).
The internal and external surface 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 (see ISO 3826-3 for further details).
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 placed (14 ± 1) 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.
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.
NOTE For the dimensions of the closure-piercing device, see ISO 1135-4.
5.8.2 Each outlet port shall be fitted with a hermetically sealed, tamper-evident protector to ma
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