IS 16004 : 2013 : Hypodermic Needles for Singal Use - Colour Coding for Indentification

Reaffirmed 2018

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 6009 : 1992 ‘Hypodermic needles for single use — Colour coding for identification’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Medical Laboratory Instruments Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard specifies colours code to enable rapid visual identification of the outside 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.

The colours used to code needles may be applied in either opaque or transparent form, and the colour code is equally applicable to normal-walled, thin-walled and extra-thin-walled needles. This does not imply that hypodermic needles of all the listed nominal outside diameters are currently manufactured.

This 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 : 1993/IS 10654 : 1991 ‘Sterile hypodermic needles for single use’.

The measurement of the colour zone of an opaque colour, especially of an item of the size and shape of the hub of a needle, is a complex procedure requiring apparatus and expertise that is to be found in relatively few laboratories and test houses. It may therefore be inconvenient, difficult or impossible for a manufacturer or purchaser routinely to assess compliance of a product with colour zone values. Such difficulties are compounded in the case of translucent colours, which are being used increasingly by needle manufacturers to allow air bubbles inside the hub to be seen and eliminated before injection.

As a consequence, the colours in this standard are specified by name, accepting that this inevitably introduces a certain amount of subjectivity in the assessment of compliance. This subjectivity may be minimized by viewing the hubs under controlled lighting conditions [for example, “daylight” (D65) illumination at 1 000 lx to 1 500 lx] and by the use of assessors of medically-demonstrated correct colour vision. Visual comparison of the colour of a product with a reference colour sample is simple and quick, and is therefore a useful routine method of product assessment. Accordingly, reference colour samples have been made available.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard.’

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point(.) as the decimal marker.