Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)

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 and the typographical characteristics of the wording for the drug name.
NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.

Anästhesie und Beatmungsgeräte - Aufkleber für Spritzen mit Arzneimitteln zur Anwendung bei der Anästhesie, die vom Anwender angebracht werden - Farben, Design und Leistung (ISO 26825:2020)

Dieses Dokument legt Anforderungen für Aufkleber für Spritzen fest, durch die der Inhalt von Spritzen vor der Anwendung bei der Anästhesie identifiziert werden kann. Es behandelt Farbe, Größe, Design und allgemeine Eigenschaften des Aufklebers sowie die typographischen Merkmale des Wortlauts für die Arzneimittelbezeichnung.
ANMERKUNG   In nationalen oder regionalen Vorschriften kann eine zusätzliche Kennzeichnung vorgeschrieben sein; dazu kann eine Strichcodierung zählen. Für diese ergänzende Kennzeichnung werden keine Anforderungen festgelegt.
ACHTUNG — Die Verwendung von Farben soll bei der Erkennung von Arzneimittelgruppen helfen und entbindet den Anwender nicht von der Pflicht, den Aufkleber zu lesen und das Arzneimittel vor der Anwendung korrekt zu identifizieren.

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 (ISO 26825:2020)

Le présent document fournit des exigences sur les étiquettes attachées aux seringues de sorte que leur contenu puisse être identifié juste avant d’être utilisé pendant l’anesthésie. Il concerne la couleur, la taille, l’aspect et les propriétés générales de l’étiquette ainsi que les caractéristiques typographiques du libellé du nom du médicament.
NOTE       Des réglementations nationales ou régionales pourraient exiger un étiquetage supplémentaire, pouvant inclure un code-barres. Aucune exigence concernant cet étiquetage supplémentaire n’est fournie.

Anestezijska in dihalna oprema - Nalepke za injekcijske brizge z zdravili, ki se uporabljajo pri anesteziji - Barve, oblika in lastnosti (ISO 26825:2020)

V tem dokumentu so podane zahteve za nalepke na injekcijskih brizgah, tako da je mogoče njihovo vsebino določiti tik pred uporabo med anestezijo. Zajete so barva, velikost, oblika in splošne lastnosti nalepke ter tipografske značilnosti besedila za ime zdravila.
OPOMBA: Nacionalni ali regionalni predpisi lahko zahtevajo dodatno označevanje, npr. črtno kodiranje. Zahteve za to dodatno označevanje niso podane.

General Information

Status
Published
Public Enquiry End Date
19-Dec-2021
Publication Date
14-Mar-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
18-Feb-2022
Due Date
25-Apr-2022
Completion Date
15-Mar-2022

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SLOVENSKI STANDARD
SIST EN ISO 26825:2022
01-april-2022
Anestezijska in dihalna oprema - Nalepke za injekcijske brizge z zdravili, ki se
uporabljajo pri anesteziji - Barve, oblika in lastnosti (ISO 26825:2020)

Anaesthetic and respiratory equipment - User-applied labels for syringes containing

drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)
Anästhesie und Beatmungsgeräte - Aufkleber für Spritzen mit Arzneimitteln zur

Anwendung bei der Anästhesie, die vom Anwender angebracht werden - Farben, Design

und Leistung (ISO 26825:2020)

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 (ISO 26825:2020)
Ta slovenski standard je istoveten z: EN ISO 26825:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 26825:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 26825:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 26825:2022
EN ISO 26825
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2022
EUROPÄISCHE NORM
ICS 11.040.10; 11.040.25
English Version
Anaesthetic and respiratory equipment - User-applied
labels for syringes containing drugs used during
anaesthesia - Colours, design and performance (ISO
26825:2020)

Matériel d'anesthésie et de réanimation respiratoire - Anästhesie und Beatmungsgeräte - Aufkleber für

Étiquettes apposées par l'utilisateur sur les seringues Spritzen mit Arzneimitteln zur Anwendung bei der

contenant des médicaments utilisés pendant Anästhesie, die vom Anwender angebracht werden -

l'anesthésie - Couleurs, aspect et propriétés (ISO Farben, Design und Leistung (ISO 26825:2020)

26825:2020)
This European Standard was approved by CEN on 7 February 2022.

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

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 26825:2022 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 26825:2022
EN ISO 26825:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 26825:2022
EN ISO 26825:2022 (E)
European foreword

The text of ISO 26825:2020 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and

respiratory equipment” of the International Organization for Standardization (ISO) and has been taken

over as EN ISO 26825:2022 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic

equipment” the secretariat of which is held by BSI.

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 August 2022, and conflicting national standards shall

be withdrawn at the latest by August 2022.

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.

Any feedback and questions on this document should be directed to the users’ national standards body.

A complete listing of these bodies can be found on the CEN website.

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 26825:2020 has been approved by CEN as EN ISO 26825:2022 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 26825:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 26825:2022
INTERNATIONAL ISO
STANDARD 26825
Second edition
2020-10
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
Reference number
ISO 26825:2020(E)
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 26825:2022
ISO 26825:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 26825:2022
ISO 26825:2020(E)
Contents Page

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 ................................................................................................................................................................................................................................ 9

© ISO 2020 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 26825:2022
ISO 26825:2020(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 121, Anaesthetic and respiratory

equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines.

This second edition cancels and replaces the first edition (ISO 26825:2008), which has been technically

revised. The main changes compared to the previous edition are as follows:

— change of the former requirement on the drug name into a recommendation in 5.4.1;

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

adrenaline;

— addition of a requirement on the size of diagonal stripes on the label in 5.4.4;

— revision of the indication of the concentration of the drug on the label;
— addition of recommendations on labelling of ready mixed drugs;
— deletion of the colour fluorescent red;

— 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 merging of the relevant information into one

table (Table 1).

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 2020 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 26825:2022
INTERNATIONAL STANDARD ISO 26825:2020(E)
Anaesthetic and respiratory equipment — User-applied
labels for syringes containing drugs used during
anaesthesia — Colours, design and performance

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

prior to use.
1 Scope

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

and the typographical characteristics of the wording for the drug name.

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

requirements for this additional labelling are given.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.

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

...

SLOVENSKI STANDARD
oSIST prEN ISO 26825:2021
01-december-2021
Anestezijska in dihalna oprema - Nalepke za injekcijske brizge z zdravili, ki se
uporabljajo pri anesteziji - Barve, oblika in lastnosti (ISO 26825:2020)

Anaesthetic and respiratory equipment - User-applied labels for syringes containing

drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)
Anästhesie und Beatmungsgeräte - Aufkleber für Spritzen mit Arzneimitteln zur

Anwendung bei der Anästhesie, die vom Anwender angebracht werden - Farben, Design

und Leistung (ISO 26825:2020)

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 (ISO 26825:2020)
Ta slovenski standard je istoveten z: prEN ISO 26825
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 26825:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 26825:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 26825:2021
INTERNATIONAL ISO
STANDARD 26825
Second edition
2020-10
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
Reference number
ISO 26825:2020(E)
ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 26825:2021
ISO 26825:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 26825:2021
ISO 26825:2020(E)
Contents Page

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 ................................................................................................................................................................................................................................ 9

© ISO 2020 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 26825:2021
ISO 26825:2020(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 121, Anaesthetic and respiratory

equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines.

This second edition cancels and replaces the first edition (ISO 26825:2008), which has been technically

revised. The main changes compared to the previous edition are as follows:

— change of the former requirement on the drug name into a recommendation in 5.4.1;

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

adrenaline;

— addition of a requirement on the size of diagonal stripes on the label in 5.4.4;

— revision of the indication of the concentration of the drug on the label;
— addition of recommendations on labelling of ready mixed drugs;
— deletion of the colour fluorescent red;

— 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 merging of the relevant information into one

table (Table 1).

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 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 26825:2021
INTERNATIONAL STANDARD ISO 26825:2020(E)
Anaesthetic and respiratory equipment — User-applied
labels for syringes containing drugs used during
anaesthesia — Colours, design and performance

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

prior to use.
1 Scope

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

and the typographical characteristics of the wording for the drug name.

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

requirements for this additional labelling are given.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.

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

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 General
4.1 Adhesive requirements
The label shall be self-adhesive and shall withstand the following test:

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

properties and represents the "worst case".

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.

d) The label shall not move, curl or lift at the edge when touched by hand.
4.2 Labels provided as a tape

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

from adjacent labels.
© ISO 2020 – All rights reserved 1
---------------------- Page: 7 ----------------------
oSIST prEN ISO 26825:2021
ISO 26825:2020(E)
Check conformity by visual inspection and functional testing.
4.3 Material

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

concentration of the drug, using a ball-point pen, without smudging or blurring.
Check conformity by functional testing.
4.4 Packaging

The label package shall be marked with a reference to this document, i.e. ISO 26825:2020.

Check conformity by visual inspection.
5 Colour, size and design requirements
5.1 General

The colour, size and design of labels applied to a syringe or cartridge by the drug manufacturer and

any labels designed to be transferred from the original medication container to a syringe should be

consistent with those specified in this document.
5.2 Background colour and designs

5.2.1 The background colours and designs shall be as specified in Table 1. The background colour shall

not be so dark as to interfere with the legibility of any additional information that is written on the label

using a black ball-point pen.
...

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