SIST EN ISO 26825:2022 PDF

Overview

EN ISO 26825:2022 (ISO 26825:2020 endorsed by CEN) specifies requirements for user‑applied labels for syringes containing drugs used during anaesthesia. The standard defines colour coding, label size and layout, adhesive and material properties, and typographic guidance so that syringe contents can be reliably identified immediately before use. It is intended as an aid to reduce medication errors during anaesthesia - noting that colour is only an aid and does not replace reading the label.

Key topics and technical requirements

• Scope and status
  • International standard ISO 26825:2020, adopted as EN ISO 26825:2022 by CEN.
  • National/regional regulations (e.g., bar coding) may require additional labelling; those are outside this document.
• Label dimensions
  • Length: 25–40 mm; width: 10–15 mm (to fit syringes without obscuring graduations).
• Adhesive and material
  • Self‑adhesive labels must remain secure after a 12 h application at (23 ± 2) °C and a 5 min immersion in 50% isopropanol, with no lifting or curling.
  • Label material must accept handwriting with a black ball‑point pen without smudging.
• Colour coding and design
  • Background colours and designs are specified (see Table 1 in the standard) to identify drug groups.
  • Opposing‑action drugs use diagonal stripes (1 mm white alternating with 1 mm coloured stripes at 45° ± 5°) with rules on stripe placement and omission behind the drug name.
  • For antagonists/oppose‑action drugs, at least the upper 20% of label width shall be striped; stripes must occupy ≥15% of label length beside the drug name.
• Typography
  • Drug name in sans‑serif font, not less than 2.5 mm letter height.
  • Use either sentence case (initial capital) or “tall‑man” lettering to distinguish similar names; no ALL CAPS.
  • Drug name placed in the upper half to leave space for concentration information below.
• Packaging and tapes
  • Label packs must reference ISO 26825:2020.
  • If supplied on a tape, cutting points must be perforated/marked and backing material must be easily separable.

Applications and users

• Intended users:
  • Anesthesia departments, operating rooms, hospital pharmacies, medical device and syringe‑label manufacturers, label suppliers, procurement and regulatory teams.
• Practical applications:
  • Standardising syringe labelling to reduce medication errors during anaesthesia.
  • Guiding design and procurement of preprinted or transfer labels and label tapes.
  • Informing hospital policies and staff training on syringe labelling best practices.

Related standards / committees

• Prepared by ISO/TC 121 (Anaesthetic and respiratory equipment) and adopted by CEN/TC 215.
• Note: check national regulations for additional labelling requirements (e.g., bar coding) which are not specified in this standard.

Keywords: EN ISO 26825:2022, ISO 26825, syringe labels, anaesthetic drugs, colour coding, syringe labelling, user‑applied labels, CEN, label design and performance.