Hypodermic needles for single use - Colour coding for identification (ISO 6009:1992)

Establishes a colour code for the identification of needles of nominal outside diameters in the range 0,3 mm to 3,4 mm. Applies to normal-walled, thin-walled and extra-thin-walled needles and to opaque and translucent colours. Annexes B and C describe colour zones for opaque colours and colour samples for opaque colours.

Medizinische Einmalkanülen - Farbcodierung zur Identifizierung (ISO 6009:1992)

Diese internationale Norm legt einen Farbcode zur Identifizierung des Nennaussendurchmessers im Bereich von 0,3mm bis 3,4mm für medizinische Einmalkanülen fest. Er wird an normal-, dünn- und extradünnwandigen Nadeln als deckende oder transparente Farbe angebracht.

Aiguilles hypodermiques non réutilisables - Code de couleurs pour l'identification (ISO 6009:1992)

La présente Norme internationale établit un code de couleurs permettant d'identifier les aiguilles hypodermiques non réutilisables de diamètres extérieurs nominaux compris entre 0,3 mm et 3,4 mm. Elle est applicable aux aiguilles à parois normales, à parois minces et à parois extra-minces, et aux couleurs opaques et translucides.

Podkožne igle za enkratno uporabo - Barvne kode za identifikacijo (ISO 6009:1992)

General Information

Status
Withdrawn
Publication Date
30-Jul-1994
Withdrawal Date
30-Aug-2016
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
31-Aug-2016

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SLOVENSKI STANDARD
SIST EN ISO 6009:2000
01-januar-2000
Podkožne igle za enkratno uporabo - Barvne kode za identifikacijo (ISO 6009:1992)
Hypodermic needles for single use - Colour coding for identification (ISO 6009:1992)
Medizinische Einmalkanülen - Farbcodierung zur Identifizierung (ISO 6009:1992)
Aiguilles hypodermiques non réutilisables - Code de couleurs pour l'identification (ISO
6009:1992)
Ta slovenski standard je istoveten z: EN ISO 6009:1994
ICS:
01.070 Barvno kodiranje Colour coding
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 6009:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 6009:2000

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SIST EN ISO 6009:2000

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SIST EN ISO 6009:2000

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SIST EN ISO 6009:2000
INTERNATIONAL
STANDARD 6009
Third edi tion
19924 2-01
Hypodermic needles for Single use - Colour
coding for identification
Aiguilles hypoderrniques non txiutilisables - Code de couleurs pour
l’iden tifica tion
Reference number
ISO 6009: 1992(E)

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SIST EN ISO 6009:2000
ISO 6009:1992(E)
Foreword
ISO (the international Organization for Standardization) is a worldwide
federation of national Standards bodies (ISO member bodies). The work
of preparing International Standards is normally carried out through ISO
technical committees. Esch member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, govern-
mental and non-governmental, in liaison with ISO, also take part in the
work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an Inter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard ISO 6009 was prepared by Technical Committee
ISO/TC 84, MedicaI devices for injectioI)s, Sub-Committee SC 1,
Syringes, needles and intravascular catheters for Single use.
This third edition cancels and replaces the second edition
(ISO 6009:1988), of which it constitutes a technical revision. The major
changes are that it covers a wider range of needle sizes, that trans-
lucent colours are included, that the colour zones previously used to
specify opaque colours are now given only for information, and that
mention is made of reference colour samples (i.e. sets of needle hubs
of the appropriate colours).
Annexes A, 8, C and D of this International Standard are for information
only.
0 ISO 1992
All rights reserved. No part of this puhlication may be reproduced or utilized in any ferm
or by any means, electronie or mechanical, including photocopying and microfilm, without
Permission in writing from the publisher.
International Oryanization for Standardization
Case Postale 56 l CH-121 1 Geneve 20 l Switzerland
Printed in Switzerland
ii

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SIST EN ISO 6009:2000
ISO 6009:1992(E)
llntroduction
The intention of this International S,tandard is to specify colours to en-
able 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. The nominal outside
diameters of needles listed in this International Standard for which col-
ours are given are those specified in ISO 9626. This does not imply that
hypodermic needles of all the listed nominal outside diameters are
currently manufactured.
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 the preparation of this lnter-
national Standard has reviewed the use of instrumentally determined
colour zones (chromaticity and luminance index) as used in previous
editions to specify opaque colours, and has decided that instrumental
measurement is not practicable. 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 ex-
pertise that is to be found in relatively few laboratories and test houses.
lt may therefore be inconvenient, difficult or impossible for a manufac-
turer 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 elim-
inated before injection.
As a consequence, the colours in this International Standard are speci-
fied 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
(e.g. “daylight” (D& illumination at 1 000 IX to 1 500 IX) 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. These take the form of sets of needle hubs of colours com-
plying with this International Standard. Details are given in annex B and
it should be noted that only those diameters of needle currently having
coloured hubs are included (i.e. 0,3 mm to 1,2 mm nominal outside di-
ameter). lt is expected that the range of diameters included in the ref-
erence colour samples will be extended in due course.
. . .
Ill

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SIST EN ISO 6009:2000
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SIST EN ISO 6009:2000
ISO 6009:1992(E)
INTERNATIONAL STANDARD
Hypodermic needles for Single use - 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
yeiiow
093
and translucent colours.
0,33 red
0,36 biue-green
2 Colour Code
medium grey
074
The colour shall indicate the nominal outside diam-
0,45 bro
...

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