EN ISO 6009:2016

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

ISO 6009:2016 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.
It 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
• Publication Date: 30-Aug-2016
• Withdrawal Date: 27-Feb-2017
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 31-Aug-2016
• Completion Date: 31-Aug-2016
• Ref Project: SIST EN ISO 6009:2016 - Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)

Relations

• Replaces: EN ISO 6009:1994 - Hypodermic needles for single use - Colour coding for identification (ISO 6009:1992)
• Effective Date: 07-Sep-2016
• Replaces: EN ISO 6009:1994/AC:2008 - Hypodermic needles for single use - Colour coding for identification (ISO 6009:1992/Cor 1:2008)
• Effective Date: 07-Sep-2016

Overview

EN ISO 6009:2016 (ISO 6009:2016) specifies a standardized colour coding system for the visual identification of single‑use hypodermic needles by nominal outer diameter. The standard covers designated metric sizes from 0.18 mm (34 Gauge) up to 3.4 mm (10 Gauge) and applies to regular‑walled, thin‑walled, extra‑thin‑walled and ultra‑thin‑walled needles in both opaque and translucent colours. It does not apply to pen‑needles. Colour coding is intended to support rapid, reliable needle identification but does not replace checking the needle size marking.

Key Topics

• Scope and purpose: Establishes a colour-to-size relationship to indicate the nominal outer diameter of single‑use needles.
• Size range: Designated metric sizes 0.18 mm to 3.4 mm (34 G to 10 G).
• Colour code table: Assigns a specific colour to each designated metric size (examples: 0.18 mm - Orange; 0.2 mm - Black; 3.4 mm - Olive brown). The full mapping is provided in Table 1 of the standard.
• Material and wall types: Applies to needles regardless of wall thickness (regular to ultra‑thin).
• Opaque vs translucent colours: Both are accommodated; translucent hubs can aid visibility of air bubbles.
• Colour references: Annex A provides reference colour samples using RAL CLASSIC (K5, 2012) and Pantone Color Bridge palettes to reduce ambiguity in colour selection.
• Measurement considerations: ISO 6009 notes that instrumental measurement of colour zones (chromaticity/luminance) can be impractical for small items; therefore colours are referenced to RAL/Pantone and some subjectivity in assessment is acknowledged.
• Implementation: The standard establishes a code but does not mandate that needles be colour‑coded or specify where the colour must be applied - those requirements may be in product standards (e.g., ISO 7864).

Applications

EN ISO 6009 is practical for:

• Medical device manufacturers - standardize hub colours, packaging, and product labeling to improve user safety and product differentiation.
• Quality assurance and regulatory teams - verify that product colour choices align with internationally recognized colour‑size mappings.
• Hospitals, clinics and clinicians - speed up needle selection in clinical workflows and reduce selection errors.
• Procurement and distributors - specify colour‑coded needle requirements in tenders and specifications to ensure compatibility across suppliers.
• Design and packaging engineers - use Annex A RAL/Pantone references to match colours consistently across components and printed materials.

Related Standards

• ISO 7864 - Sterile hypodermic needles for single use - requirements and test methods (applies to product requirements).
• ISO 9626 - Stainless steel needle tubing - requirements and test methods (relates to tubing dimensions referenced by ISO 6009).
• ISO/TR 19244 - Guidance on transition periods for ISO/TC 84 standards (implementation guidance).

Keywords: EN ISO 6009:2016, ISO 6009, colour coding, hypodermic needles, single‑use needles, needle gauge, needle identification, medical device standard.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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
ISO 6009:2016(E)
© ISO 2016, Published in Switzerland
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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 6009:2016(E)
Foreword
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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
...