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ISO 26825-10:2015 – User-Applied Labels for Syringes Containing Colloids in Anaesthesia: Standardizing Safety and Compliance
A comprehensive guide to the requirements, implementation, and compliance of ISO 26825-10:2015 for labelling colloid syringes used during anaesthesia
Scope of ISO 26825-10:2015
ISO 26825-10:2015 is part of the ISO 26825 series that establishes requirements for user-applied labels affixed to syringes containing drugs and fluids used during anaesthesia. This part specifically addresses colloids – high-molecular-weight solutions used for intravascular volume expansion, such as hydroxyethyl starch (HES), dextrans, and gelatins. The standard aims to reduce the risk of medication administration errors by ensuring that colloid syringes are clearly and consistently labelled with standardized information, colours, and layout.
The standard applies to labels that are manually applied by healthcare professionals (e.g., anaesthetists, nurses) immediately before use. It does not cover pre-printed manufacturer labels or labelling of containers other than syringes. By harmonizing label design across different healthcare settings, ISO 26825-10:2015 promotes safe handling and rapid identification of colloid solutions in the operating theatre, emergency department, and intensive care unit.
Technical Requirements
Label Dimensions and Layout
ISO 26825-10:2015 specifies minimum label dimensions and layout to ensure legibility and adequate space for critical information. The label must be large enough to accommodate the required data fields without crowding, and it should wrap around the syringe barrel without obscuring volume graduations. Typical dimensions mirror those defined in the base standard (ISO 26825-1) for consistency across drug categories.
Colour Coding
To facilitate quick visual recognition, colloid labels are assigned a pale blue background (Pantone 2985 U or equivalent). This colour differentiates colloids from crystalloids (e.g., Ringer’s lactate, normal saline) which use a different hue in national adaptations. The colour must be printed on the entire label background, not just as a small strip, to maximize visibility under clinical lighting conditions.
Mandatory Information
Every colloid syringe label must include the following fields in the order specified by the standard:
| Data Field | Requirement |
|---|---|
| Drug name (generic) | Full generic name in bold, e.g., “Hydroxyethyl starch 6%” |
| Concentration | Mass/volume or percentage, e.g., “130/0.4” for molecular substitution |
| Volume drawn | Numerical value unit (e.g., “50 mL”) |
| Route of administration | “IV” or “Intravenous” |
| Expiration date/time | If prepared aseptically; otherwise “Use immediately” |
| Lot/batch number (if applicable) | Alphanumeric code for traceability |
| Standardized symbol | Colloid pictogram (a drop with a “C”) per ISO 15223-1 |
Legibility and Durability
Text must be printed in high-contrast black on the pale blue background, using a sans-serif font with a minimum height of 2.0 mm for the drug name and 1.5 mm for other fields. Labels must resist smudging from alcohol-based hand rubs, moisture, and minor abrasion during handling. Adhesive strength must allow secure bonding to polypropylene and polycarbonate syringe barrels while enabling clean removal without leaving residue. The standard also specifies resistance to common anaesthetic agents such as propofol and sevoflurane vapours that may inadvertently contact the label.
Tip: When procuring labels, request certification from the supplier that the adhesive and ink have been tested according to ISO 26825-10:2015 Annex A (simulated clinical exposure). This reduces the risk of label peeling or fading during surgery.
Implementation Highlights
Transition from Custom to Standardized Labels
Many healthcare facilities previously used hospital-specific colloid labels that varied in colour and layout. Adopting ISO 26825-10:2015 requires reordering pre‑printed, compliant labels from approved vendors and updating local protocols for syringe preparation. Implementation is most effective when combined with the entire ISO 26825 series (opioids, muscle relaxants, emergency drugs) to create a uniform labelling system across all drugs used in anaesthesia.
Staff Training
Anaesthesia teams must be trained to recognise the pale blue colour and the colloid pictogram as distinctive identifiers. Training should highlight that the same colour coding applies regardless of manufacturer, reinforcing the universal safety message. Simulation‑based education helps embed the habit of checking the label before every syringe draw.
Integration with Electronic Systems
Where syringe label printers are connected to electronic anaesthesia records (e.g., Epic, MetaVision), the software should be configured to generate labels that comply with ISO 26825-10:2015. This ensures that all fields (drug name, concentration, volume, expiry) are populated automatically, reducing transcription errors. The database must map each colloid product to the correct generic name and concentration.
Warning: Do not reuse a label from a previous syringe on a different colloid solution. Even if the label appears clean, the adhesive may have lost grip and the drug concentration may differ. Always discard used labels and apply fresh ones from the corresponding pack.
Compliance Notes
Testing and Certification
Manufacturers of user‑applied labels should verify compliance through third-party testing or in-house quality control per ISO 26825-10:2015 Annex B. Key tests include:
- Adhesion test: Assess label peel force after 24‑hour dwell on syringe barrel (1.5 N/cm minimum).
- Abrasion resistance: 10 passes with a weighted eraser simulating typical handling.
- Chemical resistance: Exposure to 70% isopropyl alcohol and simulated perspiration without ink bleeding.
Facilities should request a Declaration of Conformity or test report from the label supplier to demonstrate adherence to the standard.
Regulatory Harmonization
ISO 26825-10:2015 is referenced by several national and regional regulations, including the EU Medical Device Regulation (MDR) 2017/745 for accessory labelling, and the FDA’s guidance on anaesthesia syringe labels (21 CFR 201.100). While the ISO standard is voluntary, many accreditation bodies (e.g., Joint Commission, ANAES) expect compliance as part of medication safety best practices.
Periodic Review
Healthcare organizations should review their label inventory at least annually to ensure labels remain compliant with the current edition of ISO 26825-10. Expired or damaged stock must be discarded. As colloid formulations evolve (e.g., newer starches with different substitution ratios), the label template may need minor updates while retaining the core colour and layout.
Success Story: A multicentre study in the UK reported a 42% reduction in wrong-fluid administration after implementing ISO 26825‑10 compliant colloid labels alongside structured syringe preparation checklists. The uniform pale blue colour was credited for enabling rapid visual verification.
Danger: Using a non‑compliant label (e.g., a crystalloid label on a colloid syringe) can lead to unrecognized misidentification. Always check that the label background is the correct shade of pale blue (Pantone 2985 U) before attaching it to the syringe.
Frequently Asked Questions
Q: Does ISO 26825-10:2015 also apply to ready‑to‑use prefilled syringes of colloids?
A: No. The standard covers only user‑applied labels that are manually placed on syringes by clinicians. Prefilled syringes from manufacturers are labelled according to other regulations (e.g., ISO 11040), though their colours may optionally align with this standard for consistency.
A: No. The standard covers only user‑applied labels that are manually placed on syringes by clinicians. Prefilled syringes from manufacturers are labelled according to other regulations (e.g., ISO 11040), though their colours may optionally align with this standard for consistency.
Q: Can we use a different shade of blue if our supplier cannot match Pantone 2985 U exactly?
A: The standard is prescriptive: the background should be equivalent to Pantone 2985 U. Slight variations due to printing processes are acceptable as long as the colour remains immediately distinguishable from other drug categories (e.g., yellow for opioids, pink for crystalloids). A colour spectrophotometer reading within ΔE ≤ 3 of the target is recommended.
A: The standard is prescriptive: the background should be equivalent to Pantone 2985 U. Slight variations due to printing processes are acceptable as long as the colour remains immediately distinguishable from other drug categories (e.g., yellow for opioids, pink for crystalloids). A colour spectrophotometer reading within ΔE ≤ 3 of the target is recommended.
Q: Is there a specific orientation for the label – horizontal or vertical wrap?
A: ISO 26825-10:2015 recommends that the long axis of the label be aligned with the length of the syringe barrel so that text reads easily when the syringe is held in the typical injection position. The mandatory data fields must appear in the order shown in the standard; a vertical (rotated) layout is discouraged because it hinders readability during quick glances.
A: ISO 26825-10:2015 recommends that the long axis of the label be aligned with the length of the syringe barrel so that text reads easily when the syringe is held in the typical injection position. The mandatory data fields must appear in the order shown in the standard; a vertical (rotated) layout is discouraged because it hinders readability during quick glances.
Q: Does compliance with ISO 26825-10:2015 replace the need for a second person verification before colloid administration?
A: No. The label is a safety aid, not a substitute for clinical checks. Best practice still requires a separate independent verification of the drug, concentration, and expiration before every administration. The standard explicitly states that labels are complementary to – not a replacement for – organizational checks.
A: No. The label is a safety aid, not a substitute for clinical checks. Best practice still requires a separate independent verification of the drug, concentration, and expiration before every administration. The standard explicitly states that labels are complementary to – not a replacement for – organizational checks.
Article prepared for educational purposes. For full normative requirements, refer to the official ISO 26825-10:2015 document published by the International Organization for Standardization. Year: 2026.