SIST EN ISO 3826-1:2019

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics 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 can contain anticoagulant and/or preservative solutions, depending on the application envisaged. This document 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 document apply to the plastics container as prepared ready for use. This document is not applicable to plastics containers with an integrated filter.

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2019)

Dieses Dokument legt Anforderungen einschließlich der geforderten Leistungsmerkmale fest für nicht belüftete, sterile Beutel (bekannt als 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 Stabilisatorlösungen enthalten.
Dieses Dokument 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 Dokument festgelegten Prüfungen für den gebrauchsfertigen Kunststoffbeutel.
Dieses Dokument 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 3826-1:2019)

Le présent document spécifie les exigences, y compris les exigences de performance, des poches en plastique souple, sans prise d'air, stériles (appelées poches en plastique), 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 le présent document sont également applicables aux poches en plastique multiples, par exemple les poches doubles, triples ou quadruples.
Sauf indication contraire, tous les essais spécifiés dans le présent document sont applicables aux poches en plastique prêtes à l'emploi.
Le présent document 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 3826-1:2019)

Ta dokument določa zahteve, vključno z zahtevami glede lastnosti, za plastične zložljive nezračene sterilne vsebnike (z drugim imenom plastične vsebnike) z izhodnimi priključki zbirne cevke, vdelano iglo in dodatnimi prenosnimi cevkami za odvzem, shranjevanje, obdelavo, transport, ločevanje ter dovajanje krvi in krvnih komponent. Plastični vsebniki lahko vsebujejo antikoagulant in/ali konzervans, odvisno od predvidene uporabe. Ta dokument se uporablja tudi za enote z več plastičnimi vsebniki, npr. za dvojne, trojne, četverne ali večje enote. Če ni navedeno drugače, se vsi preskusi, navedeni v tem dokumentu, uporabljajo za plastične vsebnike, pripravljene za uporabo. Ta dokument se ne uporablja za plastične vsebnike z vgrajenim filtrom.

General Information

• Status: Published
• Public Enquiry End Date: 24-Jun-2018
• Publication Date: 12-Nov-2019
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 24-Oct-2019
• Due Date: 29-Dec-2019
• Completion Date: 13-Nov-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 3826-1:2019 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

Relations

• Replaces: SIST EN ISO 3826-1:2013 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
• Effective Date: 01-Dec-2019
• Amended By: SIST EN ISO 3826-1:2019/A1:2023 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
• Effective Date: 01-Jun-2023
• Replaces: SIST EN ISO 3826-1:2013 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 3826-1:2019
01-december-2019
Nadomešča:
SIST EN ISO 3826-1:2013
Plastični zložljivi vsebniki za človeško kri in krvne komponente - 1. del: Običajni
vsebniki (ISO 3826-1:2019)
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO 3826-1:2019)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle
Beutel (ISO 3826-1:2019)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles (ISO 3826-1:2019)
Ta slovenski standard je istoveten z: EN ISO 3826-1:2019
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 3826-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 3826-1:2019

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SIST EN ISO 3826-1:2019


EN ISO 3826-1
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2019
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 3826-1:2013
English Version

Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers (ISO 3826-
1:2019)
Poches en plastique souple pour le sang et les Kunststoffbeutel für menschliches Blut und
composants du sang - Partie 1: Poches Blutbestandteile - Teil 1: Konventionelle Beutel (ISO
conventionnelles (ISO 3826-1:2019) 3826-1:2019)
This European Standard was approved by CEN on 25 August 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-1:2019 E
worldwide for CEN national Members.

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SIST EN ISO 3826-1:2019
EN ISO 3826-1:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 3826-1:2019
EN ISO 3826-1:2019 (E)
European foreword
This document (EN ISO 3826-1:2019) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing 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 April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 3826-1:2013.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 3826-1:2019 has been approved by CEN as EN ISO 3826-1:2019 without any
modification.


3

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SIST EN ISO 3826-1:2019

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SIST EN ISO 3826-1:2019
INTERNATIONAL ISO
STANDARD 3826-1
Third edition
2019-09
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 3826-1:2019(E)
©
ISO 2019

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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions . 2
5 Design . 2
5.1 General . 2
5.2 Air content . 3
5.3 Emptying under pressure . 3
5.4 Pilot samples . 3
5.5 Rate of collection . 3
5.6 Collection and transfer tube(s) . 5
5.7 Blood-taking needle . . 6
5.8 Outlet port(s) . 6
5.9 Suspension . 7
6 Requirements . 7
6.1 General . 7
6.2 Physical requirements . 7
6.2.1 Conditions of manufacture . 7
6.2.2 Sterilization . 7
6.2.3 Transparency . 7
6.2.4 Coloration . 8
6.2.5 Thermal stability. 8
6.2.6 Water vapour transmission . 8
6.2.7 Resistance to leakage . 8
6.2.8 Particulate contamination . 8
6.3 Chemical requirements. 9
6.3.1 Requirements for the raw container or sheeting. 9
6.3.2 Requirements for the test fluid . 9
6.4 Biological requirements .10
6.4.1 General.10
6.4.2 Impermeability for microorganisms .10
6.4.3 Compatibility .10
7 Packaging .10
8 Labelling .10
8.1 General .10
8.2 Label on plastics container .11
8.3 Label on over-package .11
8.4 Label on shipping box .12
8.5 Label requirements .12
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 2019 – All rights reserved iii

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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 3826-1:2013), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— in Clause 3 'Terms and definitions' four new entries have been added;
— in Clause 4, the designation example has been removed;
— Clause 5 'Design' has been revised, especially regarding the pilot samples, collection and transfer
tube(s), blood-taking needle and outlet port(s);
— the physical requirements in 6.2 have been slightly amended;
— Clause 8 'Labelling' has been reviewed and amended with barcoding information;
— the normative references in Clause 2 and the Bibliography have been updated.
A list of all parts in the ISO 3826 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)

Introduction
The manufacturers, or the suppliers, of plastics containers are expected to disclose in confidence to
control authorities, 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 document is considered as a basic
for other standards which include technical innovations.
The requirements in this document 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 or ISO 1135-5,
d) provide a package with appropriate resistance to breakage and deterioration.
© ISO 2019 – All rights reserved v

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SIST EN ISO 3826-1:2019

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SIST EN ISO 3826-1:2019
INTERNATIONAL STANDARD ISO 3826-1:2019(E)
Plastics collapsible containers for human blood and blood
components —
Part 1:
Conventional containers
1 Scope
This document specifies requirements, including performance requirements, for plastics collapsible,
non-vented, sterile containers (known as plastics 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 can
contain anticoagulant and/or preservative solutions, depending on the application envisaged.
This document 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 document apply to the plastics container as
prepared ready for use.
This document is not applicable to plastics containers with an integrated filter.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1135-4, Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
ISO 1135-5, Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure
infusion apparatus
ISO 3696, Water for analytical laboratory use — Specification and test methods
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at http: //www .iso .org/obp
© ISO 2019 – All rights reserved 1

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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)

3.1
plastics container
bag, of plastics material, complete with collecting tube and needle, port(s) and where applicable
anticoagulant, preservative solutions, transfer tube(s) and associated container(s)
3.2
shelf life
period between the date of sterilization and the use-by date (expiry date) of the
plastics collapsible container for human blood and blood components after which the plastics container
shall not be used for the collection of blood
3.3
sheeting
plastics material intended for the production of empty containers
[SOURCE: ISO 15747:2018, 3.12]
3.4
raw container
empty container that has not yet been sterilized and has no identification
[SOURCE: ISO 15747:2018, 3.11]
3.5
empty container
raw container with identification, which is suitable for the acceptance and storage of fluids where
applicable and to be used for testing purposes
[SOURCE: ISO 15747:2018, 3.3, modified — "and administration of the injection solution" has been
replaced by "of fluids where applicable and to be used for testing purposes".]
3.6
gauge pressure
pressure zero-referenced against local atmospheric pressure
Note 1 to entry: Container internal gauge pressure is:
— positive when the container is pressurized above the surrounding atmospheric pressure, and is
— negative when the container is subjected to suction.
[SOURCE: ISO 15747:2018, 3.4]
4 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 document; the dimensions given in
Table 1 are for guidance only.
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 or
ISO 1135-5. Its design shall also ensure that it can be used in a centrifuge cup.
2 © ISO 2019 – All rights reserved

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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)

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 or ISO 1135-5 inserted
in an outlet port (see 5.8), shall empty without visual leakage (see 6.2.7) within 2 min when gradually
squeezed between two plates to a gauge pressure of 50 kPa.
5.4 Pilot samples
The plastics container shall be designed so that pilot samples of unmistakable identity can be collected
for the performance of blood tests in the blood centre 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.
The tubing shall be designed so that stripping of the tubing up to 5 times with a tube stripper is possible
and if applicable will not remove the existing numbering system when following the plastics containers
instruction for use concerning tube stripping.
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 2019 – All rights reserved 3

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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(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.
4 © ISO 2019 – All rights reserved

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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)

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
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 opened, permits the free flow of blood
components.
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 tight leakproof connection (see 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 ± 2) °C.
There shall be no leakage at the connection 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 in
...

SLOVENSKI STANDARD
oSIST prEN ISO 3826-1:2018
01-junij-2018
3ODVWLþQL]ORåOMLYLYVHEQLNL]DþORYHãNRNULLQNUYQHNRPSRQHQWHGHO2ELþDMQL
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Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO/DIS 3826-1:2018)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle
Beutel (ISO/DIS 3826-1:2018)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles (ISO/DIS 3826-1:2018)
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 3826-1:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 3826-1:2018

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oSIST prEN ISO 3826-1:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 3826-1
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2018-03-28 2018-06-20
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
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 3826-1:2018(E)
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. ISO 2018

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oSIST prEN ISO 3826-1:2018
ISO/DIS 3826-1:2018(E)

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© ISO 2018
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ii © ISO 2018 – All rights reserved

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oSIST prEN ISO 3826-1:2018
ISO/DIS 3826-1:2018(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Dimensions . 2
5 Design . 2
5.1 General . 2
5.2 Air content . 3
5.3 Emptying under pressure . 3
5.4 Pilot samples . 3
5.5 Rate of collection . 3
5.6 Collection and transfer tube(s) . 5
5.7 Blood-taking needle . . 6
5.8 Outlet port(s) . 6
5.9 Suspension . 7
6 Requirements . 7
6.1 General . 7
6.2 Physical requirements . 7
6.2.1 Conditions of manufacture . 7
6.2.2 Sterilization . 7
6.2.3 Transparency . 8
6.2.4 Coloration . 8
6.2.5 Thermal stability. 8
6.2.6 Water vapour transmission . 8
6.2.7 Resistance to leakage . 8
6.2.8 Particulate contamination . 8
6.3 Chemical requirements. 9
6.3.1 Requirements for the raw container or sheeting. 9
6.3.2 Requirements for the test fluid . 9
6.4 Biological requirements .10
6.4.1 General.10
6.4.2 Impermeability for microorganisms .10
6.4.3 Compatibility .10
7 Packaging .10
8 Labelling .11
8.1 General .11
8.2 Label on plastics container .11
8.3 Label on over-package .11
8.4 Label on shipping box .12
8.5 Label requirements .12
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
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .23
Bibliography .25
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oSIST prEN ISO 3826-1:2018
ISO/DIS 3826-1:2018(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 3826-1:2013), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Clause 'Terms and definitions' has been enhanced by four new entries;
— Clause 'Dimensions' has been reduced by the designation example;
— Clause 'Design' has been reviewed, especially in regard of the pilot samples, collection and transfer
tube(s), blood-taking needle and outlet port(s);
— Clause 'Physical requirements' has been slightly amended;
— Clause 'Labelling' has been reviewed and amended by barcoding information;
— 'Normative references' and 'Bibliography' have been updated.
A list of all parts in the ISO 3826 series can be found on the ISO website.
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oSIST prEN ISO 3826-1:2018
ISO/DIS 3826-1:2018(E)

Introduction
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 document is considered as a basic
for other standards which include technical innovations.
The requirements in this document 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 or ISO 1135-5,
d) provide a package with appropriate resistance to breakage and deterioration.
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oSIST prEN ISO 3826-1:2018

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oSIST prEN ISO 3826-1:2018
DRAFT INTERNATIONAL STANDARD ISO/DIS 3826-1:2018(E)
Plastics collapsible containers for human blood and blood
components —
Part 1:
Conventional containers
1 Scope
This document 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 document 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 document apply to the plastics container as
prepared ready for use.
This document is not applicable to plastics containers with an integrated filter.
NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and
take precedence over this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1135-4, Transfusion equipment for medical use — Part 4: Transfusion sets for single use
ISO 1135-5, Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure
infusion apparatus
ISO 3696, 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
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oSIST prEN ISO 3826-1:2018
ISO/DIS 3826-1:2018(E)

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
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 use by date (expiry date) after which the plastics
container(s) should not be used for the collection of blood
3.3
sheeting
plastics film or foil intended for the production of raw containers
3.4
raw container
unfilled container that has not yet been sterilized and has no base label attached
3.5
empty container
raw container with a base label attached, which is suitable for the acceptance and storage of fluids
where applicable and to be used for testing purposes
3.6
gauge pressure
pressure zero-referenced against local atmospheric pressure
Note 1 to entry: Container internal gauge pressure is positive when the container is pressurized above the
surrounding atmospheric pressure and is negative when the container is subjected to suction.
4 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 document; the dimensions given in
Table 1 are for guidance only.
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 or
ISO 1135-5. Its design shall also ensure that it can be used in a centrifuge cup.
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oSIST prEN ISO 3826-1:2018
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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 or ISO 1135-5 inserted
in an outlet port (see 5.8), shall empty without visual leakage (see Note in 6.2.7) within 2 min when
gradually squeezed between two plates to a gauge pressure of 50 kPa.
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.
The tubing shall be designed so that stripping of the tubing up to 5 times with a tube stripper is possible
and if applicable will not remove the existing numbering system when following the plastics containers
instruction for use concerning tube stripping.
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.
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oSIST prEN ISO 3826-1:2018
ISO/DIS 3826-1:2018(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.
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oSIST prEN ISO 3826-1:2018
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d
Cross-sectional view.
NOTE 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
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 opened, permits the free flow of blood
components.
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 tight leakproof connection (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 ± 2) °C.
There shall be no leakage at the connection and the plastics container shall also conform to the
requirements specified in 6.2.7.
Manufacturers may use an alternative validated dynamic pull test which has been demonstrated to be
at least as stringent as the static pull test described above.
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.
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oSIST prEN ISO 3826-1:2018
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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 B.5) as a minimum requirement for such
validations (see also Reference [5]).
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 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 joint between the needle hub and the connected tubing shall withstand a static tensile (pull) force
of 20 N for 15 s along the longitudinal axis.
Manufacturers may use an alternative validated dynamic pull test which has been demonstrated to be
at least as stringent as the static pull test described above.
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 +1/-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 and 1135-5 without
leakage (see Note in 6.2.7) 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 and ISO 1135-5.
NOTE 2 When designing the outl
...