The international standard ISO 26825:2020 specifies a colour-coding system for user-applied labels on syringes prepared for use during anaesthesia. This suggestions complements ISO 26825 by specifying requirements for manufacturer-applied colour coding and labelling of ampoules, vials, prefilled syringes and outer packaging, thereby promoting consistency throughout the medication-use process.

These suggestions covers labelling on ampoules, vials and prefilled syringes, including additional transferable (“peel-off”) labels intended for attachment to syringes.

The aim is to support the identification of medicinal products used in anaesthesia, reduce the risk of medication errors and contribute to improved patient safety. The labelling and colour-coding system specified in this document is intended as an additional visual aid and does not replace the requirement for healthcare professionals to read and verify the information provided on the medicinal product container and its packaging before preparation or administration, in accordance with national or institutional requirements.

The document is drafted by Helena Brunskog, Nurse Anesthetist/Project manager Standards Norway and Lars Svarthaug, Nurse Anesthetist/Assisant Professor Norwegian University of Science and Technology in 2026. anCLEAR is a Norwegian initiative for Consistent Labelling of Anaesthesia Medications led by Lars Svarthaug. Correspondence to lars.svarthaug@ntnu.no

The International Nonproprietary Name (INN)2, or where no INN exists, the approved generic name, and the strength of the medicinal product shall be clearly displayed on all packaging and labels covered by this document.

The INN (or approved generic name) and strength shall be at least as prominent as any proprietary (brand) name, company name, logo or other marketing information. Text identifying the medicinal product name and strength shall be legible under the conditions of use typically encountered in anaesthesia, including varying lighting conditions.

Text identifying the medicinal product name and strength shall not be presented exclusively in upper-case letters. Tall Man lettering may be used to enhance the differentiation of sound-alike medicinal product names.

General

Medicinal products commonly used in anaesthesia and belonging to the drug classes specified in ISO 26825 shall be colour coded in accordance with the colours specified in table below. Additional colours may be used to distinguish between different strengths of the same medicinal product, provided that such colours do not compromise recognition of the primary drug-class colour specified in table below.

Coloured graphic elements not related to the colour-coding system, including logos, trademarks and decorative design elements, should be avoided or kept to a minimum prominence. The assigned drug-class colour should remain readily distinguishable from other graphical elements under the conditions of use typically encountered in anaesthesia, including varying lighting conditions.

NOTE As guidance, a coloured area covering approximately 20 % of the relevant packaging or label surface can be considered sufficient to achieve adequate prominence.

Outer packaging

The outer packaging of medicinal products belonging to the drug classes specified in Table 1 shall incorporate the assigned drug-class colour on at least three sides of the package.

Immediate packaging

The label of ampoules, vials and prefilled syringes shall incorporate the assigned drug-class colour specified in table below. The cap of vials shall be coloured in accordance with the drug-class colour specified or shall be white.

NOTE The vial cap colour is intended as a supplementary identification aid and does not replace the requirement to identify the medicinal product by reading the information provided on the container and its packaging.

Ampoules and vials intended for single-dose use should be provided with an additional transferable (peel-off) label to facilitate transfer of product identification to the prepared syringe.

Transferable labels shall comply with the requirements specified in ISO 26825.

Immediate packaging and outer packaging of neuromuscular blocking agents (NMBAs) shall bear the statement “WARNING: Paralysing Agent”, or an equivalent statement in the local language.

The warning statement shall be presented on a red background or within a red frame. The cap of the vials containing neuromuscular blocking agents should be red (preferably) or white and should bear the statement “WARNING: Paralysing Agent”, or an equivalent statement in the local language, on the vial cap.

NOTE Neuromuscular blocking agents present a particularly high risk of severe patient harm if administered in error.