Overview
ISO 26825:2020 specifies requirements for user-applied labels for syringes containing drugs used during anaesthesia. The standard defines the colour coding, size, typographic layout and general performance of syringe labels so that the contents can be reliably identified immediately before use. It is intended to reduce medication errors during anaesthesia and to standardize label design across manufacturers and clinical settings.
Key topics and technical requirements
- Scope and purpose: Labels for syringes and labels transferred from original medication containers; national/regional additional labelling (e.g., bar coding) is not covered.
- Adhesive performance: Labels must be self‑adhesive and resist lifting or curling after a defined conditioning and immersion test (50% isopropanol/water immersion), reflecting real clinical use.
- Material and writing: Label material must accept handwriting (e.g., ball‑point pen) without smudging or blurring.
- Size: Each label shall be between 25–40 mm length and 10–15 mm width to avoid obscuring syringe graduations.
- Colour coding and design: Background colours and designs are specified per drug classes to aid quick visual identification (examples include orange for benzodiazepines, warm red/black for many muscle relaxants, white with black border for heparin).
- Opposite-action drugs/antagonists: Use diagonal stripes (1 mm white alternating with 1 mm colour, 45° ±5°) and specific stripe placement rules; relaxant reversal drugs also have a transverse black line below the drug name.
- Typography: Drug name should be in a plain (sans serif) font, minimum 2.5 mm letter height, presented as sentence case or using “tall‑man” lettering where appropriate; drug name occupies the upper half of the label with concentration details below.
- Packaging and marking: Label packaging must reference ISO 26825:2020.
Applications
- Standardizes syringe labelling in operating theatres, intensive care units and emergency settings.
- Used by label and syringe manufacturers, medical device designers, hospital procurement teams, pharmacy departments and patient‑safety officers to specify compliant labels.
- Supports clinical protocols, training and risk‑reduction programs aimed at preventing wrong‑drug administration during anaesthesia.
Who should use this standard
- Medical device and label manufacturers
- Hospital pharmacy and anaesthesia departments
- Regulatory and compliance personnel specifying device labelling requirements
- Procurement teams writing technical specifications
Related guidance
- ISO/IEC Directives referenced for document drafting and maintenance.
- Local pharmacopoeia and national/regional regulations for drug naming, additional labelling and bar coding should be consulted alongside ISO 26825:2020.
For implementation, use ISO 26825:2020 as the baseline specification for syringe label design to improve drug identification and patient safety in anaesthetic practice.
Open preview (PDF)Anaesthetic and respiratory equipment — User-applied labels for syringes containing drugs used during anaesthesia — Colours, design and performance
