© ISO 2016 Hypodermic needles for single use — Colour coding for identification Aiguilles hypodermiques non réutilisables — Code de couleurs pour l’identification INTERNATIONAL STANDARD ISO 6009 Fourt[.]
INTERNATIONAL STANDARD ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use — Colour coding for identi fication Aiguilles hypodermiques non réutilisables — Code de couleurs pour l’iden tification Reference number ISO 6009:2016(E) © ISO 2016 ISO 6009:2016(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved Unless otherwise specified, no part o f 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 o f the requester ISO copyright o ffice Ch de Blandonnet • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii © ISO 2016 – All rights reserved ISO 6009:2016(E) Contents Page Foreword iv Introduction v Scope Terms and de finitions Colour code Annex A (informative) Reference colour samples Bibliography iii ISO 6009:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work o f 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 o f electrotechnical standardization The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part In particular the different approval criteria needed for the di fferent types o f ISO documents should be noted This document was dra fted in accordance with the editorial rules of the ISO/IEC Directives, Part (see www.iso.org/directives) Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f patent rights ISO shall not be held responsible for identi fying any or all such patent rights Details o f any patent rights identified during the development o f the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents) Any trade name used in this document is in formation given for the convenience o f users and does not constitute an endorsement For an explanation on the meaning o f ISO specific terms and expressions related to formity assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary in formation The committee responsible for this document is ISO/TC 84, Devices for adm inistration of m edicin al products an d cath eters This fourth edition cancels and replaces the third edition (ISO 6009:1992), which has been technically revised It also incorporates a Technical Corrigendum ISO 6009:1992/Cor : 008 The main changes to the previous edition o f ISO 6009 introduced by this revision are the following: a) broadening of the range of needles to designated needle size down to 0,18 mm; b) review o f the use o f instrumentally determined colour zones (chromaticity and luminance index) as used in previous editions to speci fy opaque colours and has decided that instrumental measurement is not practicable; c) revision of Annex A; d) deletion of Annex B iv © ISO 2016 – All rights reserved ISO 6009:2016(E) Introduction The intention o f this International Standard is to speci fy colours to enable rapid visual identification o f the outer diameter o f single-use hypodermic needles The presence o f colour coding on a needle or package does not absolve the user o f the responsibility to check the marked size o f the needle This revision defines, in addition, colours for more fine needles to follow the trend in the market The colours used to code needles may be applied in either opaque or transparent form, and the colour code is equally applicable to regular walled, thin-walled, extra-thin and ultra-thin walled needles The nominal outer diameters of needles lis ted in this I nternational Standard for which colours are given are those specified in ISO 9626 This International Standard establishes a colour code but does not speci fy that needles are to be colourco ded or to what p or tion of the needle and/or p ackaging the colour is to b e applied Such requirements may be given in the relevant product standards such as ISO 7864 The measurement o f the colour zone o f an opaque colour, especially o f an item o f the size and shape of the hub of a needle, is a complex pro cedure requiring app aratus and exp er tise that is to b e found in relatively few laboratories and test houses It may there fore be inconvenient, di fficult or impossible for a manu facturer or purchaser routinely to assess compliance o f a product with colour zone values Such di fficulties are compounded in the case o f translucent colours, which are being used increasingly by needle manu facturers to allow air bubbles inside the hub to be seen and eliminated be fore injection As a consequence, the colours in this International Standard are only re ferenced by a colour re ference system (RAL) or by Pantone Matching System accepting that this inevitably introduces a certain amount o f subjectivity in the assessment o f compliance Guidance on trans ition p erio ds for implementing the requirements of this I nternational Standard is given in I S O/ TR 192 4 v INTERNATIONAL STANDARD ISO 6009:2016(E) Hypodermic needles for single use — Colour coding for identi fication Scope This lnternational Standard establishes a colour code for the identification o f single-use hypodermic needles of des ignated metric s i zein the range of ,18 mm (3 Gauge) to ,4 mm (10 Gauge) It applies to regular-wal led, thin-wal led, extra-thin-wal led and u ltra-thin wal led needles , and to op aque and translucent colours T his I nternational Standard is not applicable to p en-need les Terms and de finitions For the purposes o f this document, the following terms and definitions apply 2.1 designated metric size outer diameter designation o f the tubing as defined in Table Note to entry: It is expressed in millimetres 2.2 gauge legacy size designation Note to entry: A particular gauge size corresponds to a designated metric size defining limits for outer d iameters Colour code T he colour shal l indicate the nominal outer diameter of the tub e of the needle and shal l b e as given in Table Annex A contains certain guidance to commonly applied colour re ference systems for opaque materials Table — Colour code Designated metric size Gauge Colour ,1 34 O range 0,2 33 B lack 0,23 32 D eep gre en 0, 25 31 Wh ite 0, 30 Yel low 0,33 29 Red 0, 36 28 B lue - green mm ,4 27 Medium grey ,45 26 B rown 0,5 25 O range 0, 55 24 Medium purple ISO 6009:2016(E) Table (continued) D es ignated metric si ze mm 0,6 0,7 0,8 0,9 1,1 1,2 1,4 1,6 1,8 2,1 2,4 2,7 3,4 Gauge 23 22 21 20 19 18 17 16 15 14 13 12 11 10 Colour Deep blue Black Deep green Yellow Cream Pink Red-violet White B lue - gre y Pale green Purple Pale blue Gre en-yel low Olive brown © ISO 2016 – All rights reserved ISO 6009:2016(E) Annex A (informative) Reference colour samples Table A.1 — Reference colour samples Designated metric size mm Gauge Colour 0,18 34 Orange 0,2 33 Black 0,23 32 Deep green 0,25 31 White 0,3 30 Yellow 0,33 29 Red 0,36 28 Blue-green 0,4 27 M e d iu m gre y 0,45 26 Brown 0,5 25 Orange 0,55 24 M e d iu m pu r p le RAL reference Pantone reference 2007 2003 2008 9004 9005 9017 6010 6001 6002 9003 9010 9016 1018 1021 1023 3017 3018 3031 5009 5001 5020 7047 7035 7044 8016 8017 8015 2007 2003 2008 4001 4005 Not available 1575 157 164 Black Black Black 348 349 350 11–0601 11–0602 11–0103 102 107 109 1797 711 187 3025 302 309 427 428 429 7517 7518 7519 1575 157 164 666 667 668 ISO 6009:2016(E) Table A.1 (continued) Designated metric size mm Gauge Colour 0,6 23 Deep blue 0,7 22 Black 0,8 21 Deep green 0,9 20 Yellow 1,1 19 Cream 1,2 18 Pink 1,4 17 Red-violet 1,6 16 White 1,8 15 2,1 14 Pale green 2,4 13 Purple B lue - gre y RAL reference 5005 5010 5002 9004 9005 9017 6010 6001 6002 1018 1021 1023 1014 1015 1001 Not available 3015 3014 Not available 4006 4008 9003 9010 9016 7000 7031 7011 Not available 6019 6021 4001 4005 Not available Pantone reference 294 541 540 Black Black Black 348 349 350 102 107 109 4545 4535 4527 196 197 701 2395 2405 2415 11–0601 11–0602 11–0103 7544 7545 7546 331 344 345 666 667 668 © ISO 2016 – All rights reserved ISO 6009:2016(E) Table A.1 (continued) Designated metric size mm Gauge ,7 3 ,4 12 11 10 Colour Pale blue Green-yellow O live brown RAL reference Pantone reference 01 85 C1 01 2 92 C1 024 745 C No t avai lable 67 01 368 No t avai lable 69 60 07 554 60 553 01 5605 RAL Colour palette: RAL CLASSIC Colour palette K5, Edition 2012 used for definition in ISO 6009 Two o ther colour p a lettes avai lable from R AL were no t ta ken i nto cons ideration: R AL E F FE C T C olour p a lette E , E d ition 0 R AL DE SI GN C olour p a lette D2 , E dition 01 Manufacturer: R AL gemei nnütz ige GmbH Siegburger Straße 757 S an kt Augu s ti n Germany Telephone (within Germany): 22 41 – 55 16 – 30 Telephone (internationa l) : + 49 (0) 2 41 – 5 16 – Fa x: + 49 (0) 2 41 – 5 16 - 16 E-Mail: RAL-Colours@RAL-gGmbH.de Pantone colour palette: PAN TON E C OLOR B RI D GE unco ate d PAN TON E C OLOR B RI D GE co ate d Manufacturer: Pantone LLC 59 C om merce B ou levard Carlstadt, New Jersey 70 -3 US A Tel: 01-9 -5 0 Fa x: 01- - 42 E-Mail: corpnj@pantone.com Web: w w w p antone com ISO 6009: 01 6(E) Bibliography [1] [2] ISO 7864, ISO 9626, Sterile h ypodermic n eedles for sin gle use — Requirem ents an d test m eth ods Stain less steel n eedle tubin g for th e m anufacture of m edical devices — Requirem ents an d test m eth ods [3] ISO/TR 19244, Guidan ce on tran sition periods for stan dards developed by ISO/TC 84 — Devices for admin istration of m edicin al products an d cath eters © ISO 2016 – All rights reserved ISO 6009: 01 6(E) ICS 01.070; 11.040.25 Price based on pages