prEN ISO 3826-2

Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO/DIS 3826‑2:2026)

This document addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users.
The symbols specified in this document do not replace current national regulatory requirements.
Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation.  As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This document proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings.
This document is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling.
This document may also be of assistance to different stages of the blood supply chain, e.g.:
distributors of blood collection devices (manual or automated) or other representatives of manufacturers;
blood centres and distribution centres to simplify and secure the operating procedures.
The use of these symbols is primarily intended for the medical device rather than the therapeutic product.
This document does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing.
Several of the symbols specified in this document may be suitable for application in other areas of medical technology.

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 2: Graphische Symbole zur Verwendung auf Etiketten und Beipackzetteln (ISO/DIS 3826‑2:2026)

Poches en plastique souple pour le sang et les composants du sang - Partie 2: Symboles graphiques à utiliser sur les étiquettes et les notices d'utilisation (ISO/DIS 3826‑2:2026)

L'ISO 3826-2:2008 concerne les symboles qui peuvent être utilisés pour la transmission de certaines informations relatives aux dispositifs médicaux utilisés lors des opérations de collecte ou de conservation de sang. Le symbole peut apparaître sur l'appareil lui-même, au niveau de l'étiquette, il peut aussi être fourni à part. De nombreux pays demandent que les informations figurant sur les dispositifs médicaux soient rédigées dans leur langue, cela pose donc des problèmes aux fabricants et aux futurs utilisateurs de ces appareils.
Les symboles spécifiés dans l'ISO 3826-2:2008 ne remplacent pas les exigences des réglementations nationales en vigueur.
En réduisant ou en uniformisant les variantes, les fabricants de ces dispositifs cherchent à en optimiser l'étiquetage. Cela créé alors un problème de traduction, de présentation et de logistique quand on retrouve plusieurs langues sur une seule étiquette ou notice. Pour les dispositifs utilisés pour le sang, de même que pour d'autres dispositifs médicaux, le fait que les étiquettes soient rédigées en plusieurs langues peut provoquer une certaine confusion et un retard à cause du temps perdu à chercher la langue appropriée. L'ISO 3826-2:2008 propose des solutions à ce type de problèmes en instaurant un système de symboles reconnus à l'échelle internationale et ayant une signification définie de façon précise.
L'ISO 3826-2:2008 est principalement destinée aux fabricants de dispositifs médicaux utilisés pour la collecte de sang, sa conservation et sa distribution, fabricants qui commercialisent des produits identiques dans des pays fixant des exigences linguistiques différentes en matière d'étiquetage des dispositifs médicaux.
L'ISO 3826-2:2008 peut aussi s'avérer utile à divers stades de la chaîne d'approvisionnement du sang, par exemple
pour les distributeurs d'appareils de collecte de sang (manuels ou automatiques) ou pour d'autres représentants des fabricants,
pour les centres de collecte et de distribution du sang dans le but de simplifier et de sécuriser les diverses opérations.
Ces symboles sont principalement destinés aux dispositifs médicaux plutôt qu'aux produits thérapeutiques.

Plastični zložljivi vsebniki za človeško kri in krvne komponente - 3. del: Grafični simboli, ki se uporabljajo na označbah in navodilih (ISO/DIS 3826-2:2026)

General Information

• Status: Not Published
• Publication Date: 06-Sep-2027
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 4060 - Closure of enquiry - Enquiry
• Start Date: 04-May-2026
• Completion Date: 04-May-2026
• Directive: Harmonized Standard2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: oSIST prEN ISO 3826-2:2026 - Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO/DIS 3826-2:2026)

Relations

• Revises: EN ISO 3826-2:2008 - Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)
• Effective Date: 17-Jan-2024

Overview

prEN ISO 3826-2: Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO/DIS 3826‑2:2026) is a draft international standard developed by CEN/ISO. It specifies graphical symbols for use on the labelling and instruction materials of medical devices used in blood collection, processing, and storage.

These symbols provide a standardized, language-independent way to communicate essential information about medical devices, particularly blood bags and related products. This approach addresses challenges that arise due to varying language requirements across different countries, streamlining labelling and reducing the risks and costs associated with translation and multi-language documentation.

Manufacturers, distributors, and blood centers benefit from these universally recognized graphical symbols, which enhance safety, simplify regulatory compliance, and enable easier identification and handling of blood collection devices and components worldwide.

Key Topics

• Standardized Graphical Symbols: The document defines both basic and compound symbols specific to blood collection devices and associated processes. These symbols are designed to be clear, legible, and suitable for labelling on small device surfaces and instruction leaflets.
• Language-Independent Communication: By providing internationally recognized symbols, the standard reduces reliance on translations, minimizing confusion and operational delays, especially in multinational settings.
• Alignment with Regulatory Requirements: While the symbols do not replace national regulatory requirements, their use supports compliance with European and international safety directives, including the EU Medical Device Regulation (EU 2017/745).
• Scope of Application: The symbols are intended for medical devices, not for the therapeutic product itself. They are particularly applicable to labelling plastics collapsible containers for human blood and blood components.
• Types of Symbols:
  • Basic Symbols: Convey core device information (e.g., blood type, presence of anticoagulant, apheresis protocol).
  • Compound Symbols: Communicate more specific information through combinations (e.g., plasma container, pathogen reduction process).
• Legibility and Printing: Symbols are designed for clarity and effective reproduction on typical label spaces and are suitable for both offline and online printing.

Applications

prEN ISO 3826-2 is primarily intended for:

• Manufacturers: Those who produce blood bags, blood processing containers, and transfusion devices, especially for markets with diverse language requirements. Standardized symbols allow one labelling solution for multiple countries, simplifying logistics and design.
• Distributors and Supply Chain Partners: Entities responsible for transporting, storing, and distributing blood collection devices benefit from quicker, error-reduced identification and improved operational security.
• Blood Centers and Distribution Centers: Clear, recognized symbols streamline training, minimize operating errors, and facilitate faster handling of blood components, supporting better patient safety and compliance.
• Regulatory Compliance: Adoption of these symbols helps demonstrate conformity with relevant parts of EU MDR 2017/745, as referenced in Annex ZA of the standard.

The standard also helps reduce the potential for misidentification, enhances global product traceability, and encourages best practices in medical device labelling within the blood transfusion sector.

Related Standards

For effective implementation and broader compliance, reference to these standards is essential:

• ISO 15223-1: Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
• ISO 7000: Graphical symbols for use on equipment - Registered symbols
• IEC 60417: Graphical symbols for use on equipment

These documents provide general principles and a library of symbols, many of which are incorporated and referenced in prEN ISO 3826-2. Proper alignment with these standards ensures consistency and supports seamless integration of symbol-based labelling across a variety of medical devices.

Keywords: graphical symbols, blood bag labelling, medical device labelling, ISO 3826-2, blood component containers, standardization, international medical device standards, EU MDR, language-independent symbols, transfusion equipment.

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2026
Plastični zložljivi vsebniki za človeško kri in krvne komponente - 3. del: Grafični
simboli, ki se uporabljajo na označbah in navodilih (ISO/DIS 3826-2:2026)
Plastics collapsible containers for human blood and blood components - Part 2:
Graphical symbols for use on labels and instruction leaflets (ISO/DIS 3826-2:2026)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 2: Graphische
Symbole zur Verwendung auf Etiketten und Beipackzetteln (ISO/DIS 3826-2:2026)
Poches en plastique souple pour le sang et les composants du sang - Partie 2:
Symboles graphiques à utiliser sur les étiquettes et les notices d'utilisation (ISO/DIS
3826-2:2026)
Ta slovenski standard je istoveten z: prEN ISO 3826-2
ICS:
01.080.20 Grafični simboli za posebno Graphical symbols for use on
opremo specific equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 3826-2
ISO/TC 76
Plastics collapsible containers
Secretariat: DIN
for human blood and blood
Voting begins on:
components —
2026-02-09
Part 2:
Voting terminates on:
2026-05-04
Graphical symbols for use on labels
and instruction leaflets
Poches en plastique souple pour le sang et les composants du
sang —
Partie 2: Symboles graphiques à utiliser sur les étiquettes et les
notices d'utilisation
ICS: 01.080.20; 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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.
Reference number
ISO/DIS 3826-2:2026(en)
DRAFT
ISO/DIS 3826-2:2026(en)
International
Standard
ISO/DIS 3826-2
ISO/TC 76
Plastics collapsible containers
Secretariat: DIN
for human blood and blood
Voting begins on:
components —
2026-02-09
Part 2:
Voting terminates on:
2026-05-04
Graphical symbols for use on labels
and instruction leaflets
Poches en plastique souple pour le sang et les composants du
sang —
Partie 2: Symboles graphiques à utiliser sur les étiquettes et les
notices d'utilisation
ICS: 01.080.20; 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 3826-2:2026(en)
ii
ISO/DIS 3826-2:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements for graphical symbols and their use . 2
4.1 Use of symbols .2
4.2 System of symbols .2
4.3 Basic symbols .2
4.4 Compound symbols .4
4.5 Other symbols .7
Annex A (informative) Illustrative examples of symbols used in the labelling of medical devices
used for blood treatment and transfusion . 8
Annex B (informative) Symbols as applied to properties of blood orblood components
containers .11
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .12
Bibliography .16

iii
ISO/DIS 3826-2:2026(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 3826-2:2008), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Key 1 in Figure B.1 has been corrected;
— update of normative references;
— complete editorial revision.
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/DIS 3826-2:2026(en)
Introduction
This document has been prepared to:
— reduce the need for multiple translations of words into national languages;
— simplify and rationalize the labelling of blood treatment and transfusion devices which are medical
devices used in critical situations, thereby reducing risk of misidentification, promoting safety for the
patient and reducing the amount of training required by healthcare personnel;
— promote the movement of blood treatment and transfusion devices across national boundaries;
— support the general safety and performance requirements of relevant EU Directives.
The meaning of many of these graphical symbols should be self-evident. The meaning of others will become
clear with use or when viewed in the context of the device itself. If appropriate, the meaning of symbols
should be explained in accompanying literature when provided. Annex A provides examples of how the
symbols specified in this document can be used. These are illustrative only and do not represent the only
ways in which requirements of this document can be met.

v
DRAFT International Standard ISO/DIS 3826-2:2026(en)
Plastics collapsible containers for human blood and blood
components —
Part 2:
Graphical symbols for use on labels and instruction leaflets
1 Scope
This document addresses symbols that may be used to convey certain items of information related to medical
devices dedicated to blood collection processes and storage. The information may be required on the device
itself, as part of the label, or provided with the device. Many countries require that their own language be
used to display textual information with medical devices. This raises problems to device manufacturers and
users.
The symbols specified in this document do not replace current national regulatory requirements.
Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major
problem of translation, design and logistics when multiple languages are included on a single label or piece of
documentation. As other medical devices, blood medical devices, labelled in a number of different languages,
can experience confusion and delay in locating the appropriate language. This document proposes solutions
to these problems through the use of internationally recognized symbols with precisely defined meanings.
This document is primarily intended to be used by manufacturers of medical devices dedicated to the blood
collection, process storage and distribution, who market identical products in countries having different
language requirements for medical device labelling.
This document may also be of assistance to different stages of the blood supply chain, e.g.:
— distributors of blood collection devices (manual or automated) or other representatives of manufacturers;
— blood centres and distribution centres to simplify and secure the operating procedures.
The use of these symbols is primarily intended for the medical device rather than the therapeutic product.
This document does not specify requirements relating to the size and colour of symbols although the
symbols specified have been specially designed so as to be clearly legible when reproduced in the space
typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for
on-line printing.
Several of the symbols specified in this document may be suitable for application in other areas of medical
technology.
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 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
ISO/DIS 3826-2:2026(en)
3 Terms and definitions
For the purposes of this document, the terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
basic symbol
graphical representation of a particular object or feature
3.2
compound symbol
graphical representation of a concept formed by the combination of two or more basic symbols
4 Requirements for graphical symbols and their use
4.1 Use of symbols
In use, the graphical representation of symbols shall comply with that given in Table 1 and Table 2, especially
with respect to dimensions, including relative line thickness, orientation and the absence or presence of
filled or shaded areas.
NOTE ISO and IEC jointly maintain an on-line database of graphical symbols for use on equipment, which contains
[1] [2] [3]
the complete set of graphical symbols included in ISO 7000 and IEC 60417. , In that database, each graphical
symbol is identified by a reference number and contains a title (in English and French), a graphical representation
in GIF and vectorized PDF format, and some additional data as applicable. Various search and navigation facilities
allow for easy retrieval of graphical symbols. Information on how to access this database is available through the
[4] [5]
ISO Store, the IEC Web Store or by contacting your local national standards body.
At a distance that takes into account the specifics and size of the product and its packaging, the symbols and
associated information shall be legible when viewed under an illumination of 215 lx using normal vision,
corrected if necessary.
4.2 System of symbols
The system of symbols shall comprise basic symbols (see 4.3) that may be combined to form compound
symbols (see 4.4).
NOTE Illustrative examples of labels for blood treatment and transfusion medical devices, showing the use of this
system of symbols, are given in Annex A.
4.3 Basic symbols
Basic symbols can be used alone, or in combination, to form compound symbols (see 4.4).

ISO/DIS 3826-2:2026(en)
Table 1 — Basic symbols to convey information essential for proper use
ISO 7000
No. Symbol Title and description registration
number
Blood or blood component container
On medical devices or blood process application: to indicate that
4.3.1 ISO 7000-2703
the processing or final container is used for the purpose of whole
blood or blood component storage.

Double needle apheresis protocol
On medical devices or blood process application: to indicate that

4.3.2 ISO 7000-2753
the medical device is for use by double needle apheresis protocol

Single needle apheresis protocol
On medical devices or blood process application: to indicate that

4.3.3 ISO 7000-2754
the medical device is for use by single needle apheresis protocol.

Whole blood
On medical devices or blood process application: to indicate that

4.3.4 ISO 7000-2718
the medical device is for use by single needle apheresis protocol.

Red blood cell concentrate
On medical devices or blood process application: to indicate the
4.3.5 ISO 7000-2712
presence of red blood cells concentrate obtained after centrifu-
gation of whole blood.
Plasma
On medical devices or blood process application: to indicate the

4.3.6 ISO 7000-2707
presence of plasma obtained after centrifugation of whole blood.

ISO/DIS 3826-2:20
...