ISO/PRF 26825

DRAFT INTERNATIONAL STANDARD
ISO/DIS 26825
ISO/TC 121/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-11-08 2020-01-31
Anaesthetic and respiratory equipment — User-applied
labels for syringes containing drugs used during
anaesthesia — Colours, design and performance

Matériel d'anesthésie et de réanimation respiratoire — Étiquettes apposées par l'utilisateur sur les

seringues contenant des médicaments utilisés pendant l'anesthésie — Couleurs, aspect et propriétés

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

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General ............................................................................................................................................................................................................................ 1

4.1 Adhesive requirements .................................................................................................................................................................... 1

4.2 Labels provided as a tape............................................................................................................................................................... 1

4.3 Material ......................................................................................................................................................................................................... 2

4.4 Packaging ..................................................................................................................................................................................................... 2

5 Colour, size and design requirements ............................................................................................................................................ 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Background colour and designs ............................................................................................................................................... 2

5.3 Size of label ......... ........................................................................................................................................................................................ 2

5.4 Colour, character size and positioning of drug name............................................................................................. 2

6 Regional variations ............................................................................................................................................................................................ 4

Bibliography ................................................................................................................................................................................................................................ 8

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

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

Any trade name used in this document is information given for the convenience of users and does not

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

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory

This second edition cancels and replaces the first edition (ISO 26825:2009, corrected version), which

— addition of Clause 2 (normative references) and Clause 3 (terms and definitions) to follow the

— change of the former requirement that the drug name shall be in accordance with the applicable

— revision of the labels for benzodiazepines, suxamethonium, relaxant reversal drugs and adrenaline;

— adding a requirement that diagonal stripes on the label shall be of at least 15 % in length of the label

— revision of Table 1 on background colour coding, Table 2 on representation of colours and Table A.1

on examples of alternative colour designations and merger of the relevant information into one

Any feedback or questions on this document should be directed to the user’s national standards body. A

This document gives requirements for labels attached to syringes so that the contents can be identified

just before use during anaesthesia. It covers the colour, size, design and general properties of the label

NOTE National or regional regulations might require additional labelling, which can include bar coding. No

CAUTION — The use of colours is intended only as an aid in the identification of drug groups and

does not absolve the user from the duty of reading the label and correctly identifying the drug

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

a) Apply the label to a 10 ml polyethylene syringe for at least 12 h at (23 ± 2) °C.

NOTE Polyethylene was chosen as the material of the test syringe because it has poor adhesion

b) Immerse the syringe and label in a 50 % solution (volume fraction) of isopropanol in water for 5 min.

c) After immersion, remove the syringe from the liquid, hold vertically and allow it to air dry for 5 min.

If the labels are provided as a tape, the location where the tape shall be cut between labels shall be

perforated or clearly marked. If there is backing material, the label shall be easily separable from it and

The material of the label shall be suitable for the user to write additional information upon it, e.g. the