ISO 26825-2020 pdf free.Anaesthetic and respiratory equipment — User-applied labels forsyringes containing drugs used duringanaesthesia — Colours, design andperformance.
This document gives requirements for labels attached to syringes so that the contents can be identifiedjust before use during anaesthesia. It covers the colour, size, design and general properties of the labeland the typographical characteristics of the wording for the drug name.
NOTE National or regional regulations might require additional labelling, which can include bar coding.Norequirements for this additional labelling are given.There are no normative references in this document.No terms and definitions are listed in this document.
The label shall be self-adhesive and shall withstand the following test:
a) Apply the label to a 10 ml polyethylene syringe for at least 12 h at (23 ± 2)°c.NOTE Polyethylene was chosen as the material of the test syringe because it has poor adhesionproperties and represents the “worst case”.
b)Immerse the syringe and label in a 50 % solution (volume fraction) of isopropanol in water for 5 min.c) After immersion, remove the syringe from the liquid, hold vertically and allow it to air dry for 5 min.d) The label shall not move, curl or lift at the edge when touched by hand.
Labels provided as a tape lf the labels are provided as a tape, the location where the tape shall be cut between labels shall beperforated or clearly marked. If there is backing material, the label shall be easily separable from it andfrom adjacent labels.
The material of the label shall be suitable for the user to write additional information upon it, e.g.theconcentration of the drug, using a ball-point pen, without smudging or blurring.Check conformity by functional testing.
The label package shall be marked with a reference to this document, i.e. ISO 26825:2020.Check conformity by visual inspection.
The colour, size and design of labels applied to a syringe or cartridge by the drug manufacturer andany labels designed to be transferred from the original medication container to a syringe should beconsistent with those specified in this document.The background colours and designs shall be as specified in ‘Table 1.The background colour shallnot be so dark as to interfere with the legibility of any additional information that is written on the labelusing a black ball-point pen.ISO 26825 pdf download.