ISO/DIS 3826-2:2026(en)

ISO/TC 76

Secretariat: DIN

Date: 2025-12-16

Plastics collapsible containers for human blood and blood components — Part 2: 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

Kunststoffbeutel für menschliches Blut und Blutbestandteile — Teil 2: Graphische Symbole zur Verwendung auf Etiketten und Beipackzetteln

© ISO 2026

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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

A.1 Blood and blood components containers: individual label 8

A.2 Solution container: individual label 9

A.3 Blood and blood components containers: collective shipping carton label 9

Annex B (informative) Symbols as applied to properties of blood or blood 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

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.

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.

Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets

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.

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

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

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 the complete set of graphical symbols included in ISO 7000^[1] and IEC 60417.^[2],^[3] 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 ISO Store,^[4] the IEC Web Store^[5] 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.

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.

Basic symbols can be used alone, or in combination, to form compound symbols (see 4.4).

Table 1 — Basic symbols to convey information essential for proper use

Compound symbols are formed by combination of two or more basic symbols (see 4.3).

Where necessary, symbols shall be reversed, i.e. white to black and vice-versa, to permit construction and reproduction of the compound symbol.

Table 2 — Compound symbols to convey information essential for proper use

Where additional graphical symbols are utilized in the labelling of medical devices for blood treatment and transfusion, they shall be in accordance, as appropriate, with ISO 15223-1.

1. 
   (informative)
   
   Illustrative examples of symbols used in the labelling of medical devices used for blood treatment and transfusion
   1. Blood and blood components containers: individual label

Figure A.1 and A.2 show examples of individual labels for blood and blood components containers.

Figure A.1 — Example 1 of an individual label for a blood and blood components container

Figure A.2 — Example 2 of an individual label for a blood and blood components container

• 1. Solution container: individual label

Figure A.3 shows an example of an individual label for solution container.

Figure A.3 — Example for an individual label for a solution container

• 1. Blood and blood components containers: collective shipping carton label

Figure A.4 and A.5 show examples of a collective shipping carton label for blood and blood component containers.

Figure A.4 — Example 1 of a collective label for shipping carton for blood and blood components containers

Figure A.5 — Example 2 of a proposed schematic representation of the blood collection top and bottom bag with integrated donor line including side sampling, integrated filter for red cells and platelets storage bag as presented in ISO/DIS 3826-3:2025, Figure 1

1. 
   (informative)
   
   Symbols as applied to properties of blood or
   blood components containers

Symbols, both basic and compound, for properties of blood and blood components containers are displayed in combination with a bag label that includes, for example and where appropriate:

— the nominal volume of the container;

— the name and volume of solution in the container;

— the volume of blood product to be collected in the container;

— the name(s) of the process(es) applied to the blood product and their parameters;

in the format given in Figure B.1.

Key

1 nominal volume of the container

2 name and volume of solution in the container

3 volume of whole blood product to be collected in the container

4 name(s) of the process(es) applied to the blood product and their parameters

Figure B.1 — Format to be used when including symbols on a tag label system

Annex ZA
(informative)

Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered

This European standard has been prepared under M/575 to provide one voluntary means of conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117] and to system or process requirements including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up.

Once this standard is cited in the Official Journal of the European Union under that Regulation, compliance with the normative clauses of this standard given in Table ZA.1 and application of the edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding General Safety and Performance Requirements of that Regulation, and associated EFTA Regulations.

Where a definition in this standard differs from a definition of the same term set out in Regulation (EU) 2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this Regulation prevail.

Where the European standard is an adoption of an International Standard, the scope of this standard can differ from the scope of the European Regulation that it supports. As the scope of the applicable regulatory requirements differ from nation to nation and region to region, the standard can only support European regulatory requirements to the extent of the scope of the European regulation for medical devices (EU) 2017/745).

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be ‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance Requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.

NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.

Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up

Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this Annex ZA

The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in this document, i.e. are indispensable for its application. The achievement of the presumption of conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union.

WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of this standard.

Bibliography

[1] ISO/DIS 3826‑3:2025, Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features

[2] ISO 7000, Graphical symbols for use on equipment — Registered symbols

[3] IEC 60417-DB‑12M, Graphical symbols for use on equipment — 12-month subscription to online database comprising all graphical symbols published in IEC 60417

[4] IEC 60417 ISO, 7000-DB-12M, Graphical symbols for use on equipment — 12-month subscription to online database comprising all graphical symbols published in IEC 60417 and ISO 7000

[5] Store I.S.O. https://www.iso.org/store.html

[6] Web Store I.E.C. https://webstore.iec.ch