Understanding ISO 26825:2020 Labelling Requirements

Why Labelling Requirements Matter

In operating theatres, clinicians often work with:

• Multiple drugs prepared at once

• Identical syringes

• Time-critical decisions

  
  

Without standardised labelling, the risk of misidentification and medication errors increases significantly. ISO 26825:2020 addresses this by defining exact requirements for label design, readability, and durability—ensuring labels remain clear and usable at the point of care.

1. Colour-Coding Requirements

One of the most important requirements is the use of standardised background colours to identify drug classes.

• Each drug class must use a defined colour.

• Colours must be consistent and easily distinguishable.

• Background colours must remain light enough to allow clear handwriting.

  
  

Additional Requirement: Antagonist Identification

• Labels for antagonist drugs must include:

• - Diagonal white stripes.

• - At approximately a 45° angle.

• Striping must not obscure the drug name.

  
  

This creates an additional visual safeguard for high-risk medications.

2. Label Size and Format

ISO 26825:2020 specifies strict size requirements to ensure labels fit syringes correctly:

• Length: 25–40 mm.

• Width: 10–15 mm.

  
  

Labels must:

• Fit securely without peeling.

• Avoid covering graduation markings on syringes.

• Be easy to handle and apply quickly.

3. Drug Name and Typography Requirements

The drug name is the most critical piece of information and must be displayed clearly.

Key Requirements:

• Minimum text height: 2.5 mm.

• Use clear sans-serif fonts.

• Prefer bold or semi-bold weight.

• Avoid full uppercase text.

• Use:

- Sentence case, or

- Tall Man lettering (e.g. hydrOXYzine vs hydrALAZINE).

Example: Clear Drug Name Formatting

The drug name should always be:

• The most prominent element.

• Positioned in the upper portion of the label.

4. Information Hierarchy and Layout

Labels must follow a structured layout to ensure information is read in the correct order.

Required Structure:

• Top / most prominent: Drug name.

• Below: Concentration (e.g. mg/mL).

• Optional space: Volume, time, initials.

  
  

Important Rules:

• Units should be pre-printed where possible.

• Numerical values must be clear and unambiguous.

• Avoid clutter—only essential information should be included.

  
  

5. Contrast and Readability

Labels must be readable under real clinical conditions, including poor lighting.

Requirements:

• High contrast between text and background.

• Typically black text on coloured background.

• In some cases, white text may be required for contrast.

  
  

Text must remain:

• Legible at a glance.

• Readable from different angles.

• Clear even when partially handled.

6. Material and Adhesive Performance

ISO 26825:2020 includes strict requirements for label durability.

Adhesive Requirements:

• Must be self-adhesive.

• Must remain attached after exposure to 50% isopropanol.

• Must not:

- Peel.

- Curl.

- Lift.

7. Writeability Requirements

Labels must allow clinicians to add information quickly and clearly.

Requirements:

• Must support ballpoint pen writing.

• Ink must not smudge or bleed.

• Surface must remain legible after writing.

  
  

This ensures labels remain usable in fast-paced environments.

8. Format and Usability

Labels must be designed for efficient clinical workflows.

Requirements:

• Easy to peel and apply.

• May be supplied in tape or roll format.

• Must allow quick separation.

• Packaging must clearly indicate ISO compliance.

9. Special Labelling Cases

Antagonists

• Must include diagonal striping.

  
  

Combination Drugs

• Can use:

- Multiple labels, or

- A single label representing the primary clinical effect.

High-Risk Drugs

• May require enhanced contrast or additional visual cues.

  
  

Key Takeaways

To meet ISO 26825:2020 requirements, medical labels must:

• Use standardised colour coding.

• Display clear, prominent drug names.

• Follow strict size and layout rules.

• Maintain high readability and contrast.

• Perform reliably in clinical environments.

• Support manual annotation without smudging.

  
  

Final Thoughts

ISO 26825:2020 defines exactly what safe, effective medical labelling should look like. By following these requirements, healthcare providers and suppliers can significantly reduce the risk of medication errors.

For medical label manufacturers, aligning with this standard ensures your products are:

• Clinically safe.

• Globally consistent.

• Fit for real-world use.

  
  

In conclusion, understanding and implementing the ISO 26825:2020 labelling requirements is essential for enhancing patient safety. By adhering to these guidelines, we can contribute to a more reliable healthcare environment.