What is ISO 26825 about?
ISO 26825 discusses user-applied labels for syringes containing drugs used during anaesthesia for anaesthetic and respiratory equipment. ISO 26825 gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name.
The background colours and designs shall be as specified in Table 1. The background colour shall not be so dark as to interfere with the legibility of any additional information that is written on the label using a black ball-point pen.
Note: National or regional regulations might require additional labelling, which can include barcoding. No requirements for this additional labelling are given.
Who is ISO 26825 for?
ISO 26825 on user-applied labels for syringes containing drugs used during anaesthesia is useful for:
- Manufactures of syringes for medical uses
- Test laboratories
- Regulatory authorities
Why should you use ISO 26825?
Incomplete and inaccurate labelling of injectable medicine and fluids is a risk in the safe administration of medicines. The labelling helps users identify contents just before use during anaesthesia.
ISO 26825 guideline outlines adhesive requirements, labels provided as a tape, material, packaging, size of label, colour, character size and positioning of the drug name, size, and design requirements for User-applied labels for syringes. This helps to promote safer use of medicine through standardization and best practice.
What’s changed since the last update?
BS ISO 26825:2020 supersedes ISO 26825:2008, which has been withdrawn. BS ISO 26825:2020 has some technical changes with respect to ISO 26825:2008. These include:
- Change of the former requirement on the drug name into a recommendation in 5.4.1
- Revision of the labels for benzodiazepines, suxamethonium, muscle relaxant reversal drugs and adrenaline
- Addition of a requirement on the size of diagonal stripes on the label in 5.4.4
- Revision of the indication of the concentration of the drug on the label
- Addition of recommendations on labelling of ready mixed drugs
- Deletion of the colour fluorescent red
