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IS 16004 (2013): Hypodermic Needles for Single Use - Colour

Coding for Identification [MHD 10: Medical Laboratory
Instruments]

“!ान $ एक न' भारत का +नम-ण”

Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता ह”

है”
ह
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“Knowledge is such a treasure which cannot be stolen”
 IS 16004 : 2013
ISO 6009 : 1992

Hkkjrh; ekud
,d ckj mi;ksx dh vèkLoph; lqb;k¡ —
igpku osQ fy, jax dksfMax

Indian Standard
HYPODERMIC NEEDLES FOR SINGLE USE —
COLOUR CODING FOR IDENTIFICATION

ICS 01.070; 11.040.25

© BIS 2013
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002

February 2013 Price Group 5

Medical Laboratory Instruments Sectional Committee, MHD10

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.

Technical corrigendum 1 published in 2008 to the above International Standard has been given at the
end of this publication.

In this adopted standard, reference appear to the following International Standard for which Indian
Standard also exists. The corresponding Indian Standard, which is to be substituted in its place is
listed below along with its degree of equivalence for the edition indicated:

(Continued on third cover)

 IS 16004 : 2013
ISO 6009:1992(E)
INTERNATIONAL STANDARD
ISO 6009 : 1992

Indian Standard
HYPODERMIC NEEDLES FOR SINGLE USE —
HypodermicCOLOUR
needles CODING
for Single FOR
use - IDENTIFICATION
Colour coding for
ident ificat ion

1 Scope
Table 1 - Colour code
This International Standard establishes a colour Nominal outside
code for the identification of Single-use hypodermic diameter of needle Colour
needles of nominal outside diameters in the range mm
0,3 mm to 3,4 mm. It applies to normal-walled, thin-
walled and extra-thin-walled needles and to opaque
093 yeiiow
and translucent colours.
0,33 red

2 Colour Code 0,36 biue-green

074 medium grey
The colour shall indicate the nominal outside diam- 0,45 brown
eter of the tube of the needle, and shall be as given 03 orange
in table 1.
0,55 medium purpie
NOTES 08 deep biue
1 Attention is drawn to the sets of reference hubs avaii- 097 biack
abie as reference coiour sampies (see annex A). 018 deep green
099 yeiiow
2 The coiour zones of opaque coiours, and the nearest
coiour sampies in a number of coiour atiases are given for hl cream
information in annexes B and C respectiveiy. 192 pink
14 red-vioiet
186 white
13 biue-grey
291 pale green
294 purpie
z7 pale blue
3 green-yeiiow
34 Olive brown

1
ISO 6009:1992(E)
IS 16004 : 2013
ISO 6009 : 1992

Annex A
(informative)

Reference colour samples

The reference colour samples referred to in this International Standard are available by contacting:

Melab
Medizintechnik und Labor GmbH
Heimsheimer Weg 17
D-7259 Friolzheim
Germany

Tel: + 70 44 4 18 84
Fax: + 70 44 4 24 20
This information is given for the convenience of the users of this International Standard and does not constitute
an endorsement by ISO of the reference colour samples.

2
 ISO 6009:1992(E)
IS 16004 : 2013
ISO 6009 : 1992

Annex B
(informative)

Colour zones for opaque colours

13.1 Conditions of colour measurement c) Illuminant: C Source in accordance with CIE

Publication No. 15.2;
The chromaticity (x, v) and luminance index
Y (fl = IO-*Y) are determined with a spectropho- d) Reference white: perfett reflecting diffuser, ap-
tometer by the equidistant wavelengths method proximated by a barium sulfate plate.
(AA = 10 nm) under the following conditions:
8.2 Colour zones
a) Lighting and examination condition: (O/d), in ac-
cordante with CIE Publication No. 15.2, specular The colour zones for opaque colours are given in
brilliant excluded; table B.I.
b) Reference colorimetric observer: 2’, in accord-
ante with CIE Publication No. 15.2;

Table B.1 - Colour zones for opaque colours

Nominal Colour Colour zone
outside
Gameter of
needle
mm

093 yellow sc = 0,448 x = 0,507

y = 0,468 y = 0,492
ß > 0,40
sc = 0,488 x = 0,468
y = 0,511 y = 0,456

0,33 red x = 0,540 x = 0,560

y = 0,326 y = 0,280
0,lO < ß < 0,20
x = 0,500 x = 0,610
y = 0,289 y = 0,330

0,36 blue-green x = 0,203 x = 0,267

y = 0,300 y = 0,347
0,30 < ß < 0,50
x = 0,246 x = 0,234
y = 0,306 y = 0,370

074 medium grey x = 0,302 x = 0,323

y = 0,314 y = 0,315
0,20 < ß < 0,65
x = 0,313 x = 0,303
y = 0,324 y = 0,302

3
ISO 6009:1992(E)
IS 16004 : 2013
ISO 6009 : 1992

Nominal Colour Colour xone

outside
diameter of
needle
mm

0,45 brown x = 0,360 x = 0,452

y = 0,332 y = 0,338
0,04 < ß < 0,15
x = 0,440 x = 0,367
y = 0,356 y = 0,325

095 orange x = 0,482 x = 0,561

y = 0,394 y = 0,394
0,22 < ß < 0,40
x = 0,542 x = 0,498
y = 0,421 y = 0,375

0,55 medium x = 0,258 x = 0,294

purple y = 0,193 y = 0,243
0,07 < ß < 0,20
x = 0,274 x = 0,285
y = 0,237 y = 0,201
--"-
096 deep blue x = 0,151 x = 0,203
y = 0,178 y = 0,182
0,05 < ß < 0,lO
x = 0,197 x = 0,164
y = 0,218 y = 0,132

0'7 black x = 0,296 x = 0,350

y = 0,313 y = 0,319
ß < 0,05
x=o,315 x = 0,290
y = 0,338 y = 0,273

0'8 deep green x=O,O13 x = 0,310

y = 0,745 y = 0,441
0,09 < ß < 0,20
x = 0,310 x = 0,254
1' = 0,685 y = 0,397

03 yellow x = 0,448 x = 0,507

y = 0,468 y = 0,492
ß > 0,40
x = 0,488 x = 0,468
Y = 0,511 y = 0,456

4
 IS 16004
ISO : 2013
6009:1992(E)
ISO 6009 : 1992

Nominal Colour Colour zone

outside
diameter of
needle
mm

IV1 cream x = 0,331 x = 0,377

y = 0,341 y = 0,364
0,65 < ß < 0,80
x = 0,356 x = 0,341
y = 0,372 y = 0,337

192 pink x = 0,328 x = 0,407

y = 0,308 y = 0,338
0,40 < ß < 0,60
x = 0,332 x = 0,373
y = 0,321 y = 0,282

14 red-violet x = 0,300 x = 0,320

y = 0,287 y = 0,270
0,40 < ß < 0,65
x = 0,288 x = 0,316
y = 0,254 y = 0,293

196 white x = 0,297 x = 0,330

y = 0,308 y = 0,318
ß > 0,80
x = 0,310 x = 0,303
y = 0,326 y = 0,295

18 blue-grey x = 0,250 x = 0,295

y = 0,267 y = 0,314
0,lO < p < 0,20
x = 0,262 x = 0,290
y = 0,309 y = 0,299

Zl pale green x = 0,302 x = 0,320

y = 0,367 y= 0,339 .
0,45 < ß < 0,65
x = 0,337 x = 0,307
y = 0,376 y = 0,336

294 purple x = 0,329 x = 0,411

y = 0,233 y = 0,241
0,lO < ß c 0,20
x = 0,338 x = 0,376
y = 0,194 y = 0,267

55
 ISO
IS 6009:1992(Q
16004 : 2013
ISO 6009 : 1992

Nominal Colour Colour zone

outside
diameter of
needle
mm

297 pale blue x = 0,197 x = 0,291

y = 0,197 y = 0,306
0,20 < ß < 0,65
x = 0,200 sc= 0,289
y = 0,260 y = 0,294

3 green-yellow x = 0,350 x = 0,380

y = 0,525 y = 0,450
0,30 < ß < 0,50
x = 0,336 x = 0,420
y = 0,450 y = 0,525

394 Olive brown x = 0,402 x = 0,392

y = 0,443 y = 0,372
0,lO < ß < 0,25
x = 0,362 x = 0,454
y = 0,386 y = 0,415

6
 ISO 6009:1992(E)
IS 16004 : 2013
ISO 6009 : 1992

Annex C
(informative)

Colour samples for opaque colours

The nearest colour samples to the colours given in this international Standard are given in table Cl.

Table Cl - Colour samples for opaque colours

Nominal outside
diameter of needle
r Colour samples

mm Munsell atlas Fed. Std. 595a RAL 840 HR NF X 08-002

093 3,75 Y 8114 23 655 1021 1 330

0,33 - - - -
0,36 7,5 BG 518 - - -
094 N7 26 231 7 035 3 630
0,45 10 R 414 10075 8 017 2 020
015 3,75 YR 6112 12473 2 003 1 130
0,55 2,5 P 418 27 144 4 005 2 710
03 2,5 PB 318 15090 5010 1 540
07 N 2,0 27 038 9 005 2 603
098 2,5 G 418 14 090 6 001 2 455
099 3,75 Y 8114 23 655 1021 1 330
IJ 10 YR 912 27 769 1015 2 225
12 2,5 R 716 11 630 3 015 2 870
196 N 9,5 27 875 9 010 2 665
198 5,0 0 412 35 189 7 031 3 520
291 10 GY 812 24 504 6 019 3 470
24 - - - -

217 2,5 PB 718 35 190 5012 2 590

3 - - - -

34 - - - -

7
lSQW09:1992(E)
IS 16004 : 2013
ISO 6009 : 1992

Annex D
(infkmative)

Bibliography

[l] ISO 7864:1988, Sterile hypodermic needles for [S] German Standard RAL 840, HR Farb/-egister
Single use. (Colour register).4)

[2] ISO 9626:1991, Stainless steel needle tubing for [7] French Standard NFX 08-002, Collection reduite
the manufacture of medical devices. des couleurs - Designation et catalogue des
cowleurs CCR - italons secondaires (Limited
[3] CIE Publication No. 15.2:1986, Co1orimetry.l) collection of colours - Designafion and cata-
logue of CCR colours - Secondary
[4] Munsell Book of Color.2) Standards)!)

[5] USA Federal Standard 595a, Colors-Vol. k3)

1) Available from the Honorary Librarian (National Illumination Committee of Great Britain), c/o The Library, Thorn
Lighting Ltd., 146 Lincoln Road, Enfield, Middlesex EN1 ISB, UK.
2) Available from Munsell Color, 2441 N. Calvert Street, Baltimore, MD 21218, USA.
3) Available from Superintendent of Documents, US Government Printing Office, Washington DC 20402, USA.
4) Available from RAL Deutsches Institut für Gütesicherung und Kennzeichnung eV, Bornheimer Strasse 180, 5300
Bonn 1, Germany.
5) Available from AFNOR, Tour Europe, Cedex 7, 92080 Paris La Defense, France.

8
8
 IS 16004 : 2013
ISO 6009 : 1992

TECHNICAL CORRIGENDUM 1

Technical Corrigendum 1 to ISO 6009:1992 was prepared by Technical Committee ISO/TC 84, Devices for
administration of medicinal products and intravascular catheters.

Page 2

Replace Annex A with the following.

Annex A
(informative)

Reference colour samples

The reference colour samples referred to in this International Standard are available by contacting:
Melab
Medizintechnik und Labor GmbH
Mollenbachstrasse 19
71229 Leonberg
Germany
[email protected]

This information is given for the convenience of the users of this International Standard and does not constitute
an endorsement by ISO of the reference colour samples.

9
(Continued from second cover)

International Standard Corresponding Indian Standard Degree of Equivalence

ISO 7864 : 1993 Sterile hypodermic IS 10654 : 1991 Sterile hypodermic Identical
needles for single use needles for single use

For the purpose of deciding whether a particular requirement of this standard is complied with, the
final value, observed or calculated, expressing the result of a test, shall be rounded off in accordance
with IS 2 : 1960 ‘Rules for rounding off numerical values (revised)’. The number of significant places
retained in the rounded off value should be the same as that of specified value in this standard.
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Review of Indian Standards

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referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: Monthly Additions’.

This Indian Standard has been developed from Doc No.: MHD 10 (0062).

Amendments Issued Since Publication

______________________________________________________________________________________
Amendment No. Date of Issue Text Affected
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________

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