SIST EN ISO 6009:2016

Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)

This lnternational Standard establishes a colour code for the identification of single-use hypodermic
needles of designated metric sizein the range of 0,18 mm (34 Gauge) to 3,4 mm (10 Gauge) . It applies
to regular-walled, thin-walled, extra-thin-walled and ultra-thin walled needles, and to opaque and
translucent colours.
This International Standard is not applicable to pen-needles.

Medizinische Einmalkanülen - Farbcodierung zur Identifizierung (ISO 6009:2016)

Aiguilles hypodermiques non réutilisables - Code de couleurs pour l'identification (ISO 6009:2016)

L'ISO 6009:2016 établit un code de couleurs permettant d'identifier les aiguilles hypodermiques non réutilisables dont les tailles métriques désignées vont de 0,18 mm (Calibre 34) à 3,4 mm (Calibre 10). Elle est applicable aux aiguilles à paroi normale, à paroi mince, à paroi extra-mince et à paroi ultra-mince, ainsi qu'aux couleurs opaques et translucides.
L'ISO 6009:2016 ne s'applique pas aux aiguilles pour stylo injecteur.

Podkožne igle za enkratno uporabo - Barvne kode za identifikacijo (ISO 6009:2016)

Ta mednarodni standard določa barvne kode za prepoznavanje podkožnih igel za enkratno uporabo z metrično označbo velikosti od 0,18 mm (34 gauge) do 3,4 mm (10 gauge). Uporablja se
za igle z normalno debelimi stenami, tankimi stenami, zelo tankimi stenami in ultratankimi stenami, in za neprozorne in prosojne barve.
Ta mednarodni standard se ne uporablja za igle za peresnike.

General Information

• Status: Published
• Public Enquiry End Date: 04-Mar-2015
• Publication Date: 17-Oct-2016
• ICS: 01.070 - Colour coding
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 12-Sep-2016
• Due Date: 17-Nov-2016
• Completion Date: 18-Oct-2016
• Ref Project: EN ISO 6009:2016 - Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)

Relations

• Replaces: SIST EN ISO 6009:2000/AC:2008 - Hypodermic needles for single use - Colour coding for identification (ISO 6009:1992/Cor 1:2008)
• Effective Date: 01-Nov-2016
• Replaces: SIST EN ISO 6009:2000 - Hypodermic needles for single use - Colour coding for identification (ISO 6009:1992)
• Effective Date: 01-Nov-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 6009:2016
01-november-2016
1DGRPHãþD
SIST EN ISO 6009:2000
SIST EN ISO 6009:2000/AC:2008
Podkožne igle za enkratno uporabo - Barvne kode za identifikacijo (ISO 6009:2016)
Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
Medizinische Einmalkanülen - Farbcodierung zur Identifizierung (ISO 6009:2016)
Aiguilles hypodermiques non réutilisables - Code de couleurs pour l'identification (ISO
6009:2016)
Ta slovenski standard je istoveten z: EN ISO 6009:2016
ICS:
01.070 Barvno kodiranje Colour coding
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 6009:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 6009:2016

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SIST EN ISO 6009:2016


EN ISO 6009
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2016
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 6009:1994
English Version

Hypodermic needles for single use - Colour coding for
identification (ISO 6009:2016)
Aiguilles hypodermiques non réutilisables - Code de Medizinische Einmalkanülen - Farbcodierung zur
couleurs pour l'identification (ISO 6009:2016) Identifizierung (ISO 6009:2016)
This European Standard was approved by CEN on 24 August 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6009:2016 E
worldwide for CEN national Members.

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SIST EN ISO 6009:2016
EN ISO 6009:2016 (E)
Contents Page
European foreword . 3

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SIST EN ISO 6009:2016
EN ISO 6009:2016 (E)
European foreword
This document (EN ISO 6009:2016) has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and catheters" in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2017, and conflicting national standards
shall be withdrawn at the latest by February 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 6009:1994.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 6009:2016 has been approved by CEN as EN ISO 6009:2016 without any modification.
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SIST EN ISO 6009:2016

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SIST EN ISO 6009:2016
INTERNATIONAL ISO
STANDARD 6009
Fourth edition
2016-08-01
Hypodermic needles for single use —
Colour coding for identification
Aiguilles hypodermiques non réutilisables — Code de couleurs pour
l’identification
Reference number
ISO 6009:2016(E)
©
ISO 2016

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SIST EN ISO 6009:2016
ISO 6009:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

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SIST EN ISO 6009:2016
ISO 6009:2016(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Colour code . 1
Annex A (informative) Reference colour samples . 3
Bibliography . 6
© ISO 2016 – All rights reserved iii

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SIST EN ISO 6009:2016
ISO 6009:2016(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. Each 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, governmental 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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent
...