Overview

The intention of this International Standard is to specify colours to enable rapid visual identification of the outer diameter of single-use hypodermic needles. The presence of colour coding on a needle or package does not absolve the user of the responsibility to check the marked size of the needle. This revision defines, in addition, colours for more fine needles to follow the trend in the market. The colours used to code needles may be applied in either opaque or transparent form, and the colour code is equally applicable to regular walled, thin-walled, extra-thin and ultra-thin walled needles. The nominal outer diameters of needles listed in this International Standard for which colours are given are those specified in ISO 9626. This International Standard establishes a colour code but does not specify that needles are to be colour coded or to what portion of the needle and/or packaging the colour is to be applied. Such requirements may be given in the relevant product standards such as ISO 7864. The Technical Committee responsible for preparation of this International Standard revised the use of instrumentally determined colour zones and decided that instrumental measurement is not practicable. Due to the difficulty of measuring the colour range of an opaque or even transparent colour, the colours in this International Standard are only referenced by a colour reference system (RAL) or by Pantone Matching System accepting that this inevitably introduces a certain amount of subjectivity in the assessment of compliance. This document has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" (secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany). At DIN, the German Institute for Standardization e. V., the responsible committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at DIN Standards Committee Medicine (NAMed).

Document: references other documents

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices