ISO 26825 pdf free download

ISO 26825-2020 pdf free download.Anaesthetic and respiratory equipment一User-applied labels for syringes containing drugs used during anaesthesia一Colours, design and performance.
4.3 Material
The material of the label shall be suitable for the user to write additional information upon it, e.g. the concentration of the drug, using a ball-point pen, without smudging or blurring.
Check conformity by functional testing.
4.4 Packaging
The label package shall be marked with a reference to this document. i.e. Iso 26825:2020.
Check conformity by visual inspection.
5 Colour, size and design requirements
5.1 General
The colour, size and design of labels applied to a syringe or cartridge by the drug manufacturer and any labels designed to be transferred from the original medication container to a syringe should be consistent with those specified in this document.
5.2 Background colour and designs
5.2.1 The background colours and designs shall be as specified in Tablel. 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 hall-point pen.
Check conformity by visual inspection.
5.2.2 To denote a drug of opposite action (including antagonists). 1 mm wide diagonal white stripes, alternating with 1 mm wide stripes of designated colour, shall be used (see Table 1). The stripes shall run from the lower left to the upper right at an angle of(45 ± 5)° to the long axis of the label. The striping shall be omitted behind and below the drug name (see 5AA and Table 1, Examples No. 4, 8, 11, 13 and 16).
Check conformity by visual inspection and functional testing.
5.3 Size of label
Each label shall have a length of between 25 mm and 40 mm and a width of between 10 mm and 15 mm. NOTE The size of the label was chosen so that it will fit most sizes of syringe without obscuring the graduation marks.
Check conformity by measurement.
5.4 Colour, character size and positioning of drug name
5.4.1 The drug name should be in accordance with the pharmacopoeia of the country in which the label is used.
5.4.2 The height of the letters used for the drug name should be as large as possible and shall be not less than 2,5 mm in a plain (sans serif) font with approximately similar proportions of line and space in the letters (i.e. bold or semi-bold style). Either of the following forms of presentation shall be used:
a) lower case letters with an initial upper case letter;
b) lower case letters with the distinguishing parts of similar drug names in upper case letters (known as tall-man lettering)
All upper case lettering shall not be used.
NOTE I When “tall•man lettering is applied, see recommendations in Reference 111 and see Table 1. Example No. 12.
NOTE 2 See Clause 6 for non-Roman alphabets.
Different letter sizes can be used:
— for drug names with many letters (e. g. Calciumgluconate) in order to increase readability of more important parts of the name;
— for drugs that are used in different concentrations (e.g. SUFentanil 5 tg/ml and 25 i.g/ml). Check conformity by visual inspection and measurement.
5.4.3 The name of the drug shall be printed on the upper half of the label to allow space for the drug concentration to be written or printed in the lower half.
Check conformity by visual inspection.
5.4.4 For drugs of opposite action (including antagonists), at least the upper 20 % of the width of the label shall be marked with diagonal stripes (see Table 1. Examples No. 4, 8, ii, 13 and 16). The diagonal stripes of each side of the drug name shall take up at least 15 % of the length of the label. The top of the drug name shall be separated from the diagonal stripes by at least 0,5 mm.
Relaxant reversal drugs should be made more discernible from all other drugs of opposite action and antagonists by the addition of a transverse black line below the drug name (see Tablel. Example No. 11). The black line should be 1 mm thick and limited to the width of the drug name.
Check conformity by visual inspection.ISO 26825 pdf download.