1、BS EN ISO 6009:2016Hypodermic needles for singleuse Colour coding foridentificationBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 6009:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 6009:2016. It supersedes B
2、S EN ISO 6009:1994 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the nece
3、ssary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 86071 3 ICS 01.070; 11.040.25 Compliance with a British Standard cannot confer immunity from legal obligations.This British
4、Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6009 August 2016 ICS 11.040.25 Supersedes EN ISO 6009:1994
5、English Version Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016) Aiguilles hypodermiques non rutilisables - Code de couleurs pour lidentification (ISO 6009:2016) Medizinische Einmalkanlen - Farbcodierung zur Identifizierung (ISO 6009:2016) This European Standard w
6、as 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 n
7、ational 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 la
8、nguage 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, Gree
9、ce, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG C
10、EN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 6009:2016 EBS EN ISO 6009:2016EN ISO 6009:2016 (E) 3 European foreword This document (EN ISO 6009:2016) has be
11、en 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 stan
12、dard, 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 righ
13、ts. 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 Stand
14、ard: 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, Spa
15、in, 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. BS EN ISO 6009:2016ISO 6009:2016(E)Foreword ivIntroduction v1 Scope . 12 Terms and definitions . 13 Colour code . 1Annex A (info
16、rmative) Reference colour samples 3Bibliography 6 ISO 2016 All rights reserved iiiContents PageBS EN ISO 6009:2016ISO 6009:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Interna
17、tional 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
18、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, P
19、art 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
20、 elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations re
21、ceived (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs a
22、dherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal products and catheters.This fourth edition cancels and replaces the th
23、ird edition (ISO 6009:1992), which has been technically revised. It also incorporates a Technical Corrigendum ISO 6009:1992/Cor.1:2008.The main changes to the previous edition of ISO 6009 introduced by this revision are the following:a) broadening of the range of needles to designated needle size do
24、wn to 0,18 mm;b) review of the use of instrumentally determined colour zones (chromaticity and luminanceindex) as used in previous editions to specify opaque colours and has decided that instrumentalmeasurement is not practicable;c) revision of Annex A;d) deletion of Annex B.iv ISO 2016 All rights r
25、eservedBS EN ISO 6009:2016ISO 6009:2016(E)IntroductionThe intention of this International Standard is to specify colours to enable rapid visual identification of the outer diameter of single-use hypodermic needles. The presence of colour coding on a needle or package does not absolve the user of the
26、 responsibility to check the marked size of 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 walle
27、d, thin-walled, extra-thin and ultra-thin walled needles. The nominal outer diameters of needles listed in this International Standard for which colours are given are those specified in ISO 9626.This International Standard establishes a colour code but does not specify that needles are to be colour-
28、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 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 comp
29、lex 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 com
30、pounded 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 International Standard are only referenced by a colour reference system (RAL) or
31、by Pantone Matching System accepting that this inevitably introduces a certain amount of subjectivity in the assessment of compliance.Guidance on transition periods for implementing the requirements of this International Standard is given in ISO/TR 19244. ISO 2016 All rights reserved vBS EN ISO 6009
32、:2016BS EN ISO 6009:2016Hypodermic needles for single use Colour coding for identification1 ScopeThis 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
33、 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.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1designated metri
34、c sizeouter diameter designation of the tubing as defined in Table 1Note 1 to entry: It is expressed in millimetres.2.2gaugelegacy size designationNote 1 to entry: A particular gauge size corresponds to a designated metric size defining limits for outer diameters.3 Colour codeThe colour shall indica
35、te the nominal outer diameter of the tube of the needle and shall be as given in Table 1.Annex A contains certain guidance to commonly applied colour reference systems for opaque materials.Table 1 Colour codeDesignated metric size mmGauge Colour0,18 34 Orange0,2 33 Black0,23 32 Deep green0,25 31 Whi
36、te0,3 30 Yellow0,33 29 Red0,36 28 Blue-green0,4 27 Medium grey0,45 26 Brown0,5 25 Orange0,55 24 Medium purpleINTERNATIONAL STANDARD ISO 6009:2016(E) ISO 2016 All rights reserved 1BS EN ISO 6009:2016ISO 6009:2016(E)Designated metric size mmGauge Colour0,6 23 Deep blue0,7 22 Black0,8 21 Deep green0,9
37、20 Yellow1,1 19 Cream1,2 18 Pink1,4 17 Red-violet1,6 16 White1,8 15 Blue-grey2,1 14 Pale green2,4 13 Purple2,7 12 Pale blue3 11 Green-yellow3,4 10 Olive brownTable 1 (continued)2 ISO 2016 All rights reservedBS EN ISO 6009:2016ISO 6009:2016(E)Annex A (informative) Reference colour samplesTable A.1 Re
38、ference colour samplesDesignated metric size mmGauge Colour RAL referencePantone reference0,18 34 Orange20072003200815751571640,2 33 Black900490059017Black 3Black 4Black 60,23 32 Deep green6010600160023483493500,25 31 White9003901090161106011106021101030,3 30 Yellow1018102110231021071090,33 29 Red30
39、173018303117977111870,36 28 Blue-green50095001502030253023090,4 27 Medium grey7047703570444274284290,45 26 Brown8016801780157517751875190,5 25 Orange20072003200815751571640,55 24 Medium purple40014005Not available666667668 ISO 2016 All rights reserved 3BS EN ISO 6009:2016ISO 6009:2016(E)Designated m
40、etric size mmGauge Colour RAL referencePantone reference0,6 23 Deep blue5005501050022945415400,7 22 Black900490059017Black 3Black 4Black 60,8 21 Deep green6010600160023483493500,9 20 Yellow1018102110231021071091,1 19 Cream1014101510014545453545271,2 18 PinkNot available301530141961977011,4 17 Red-vi
41、oletNot available400640082395240524151,6 16 White9003901090161106011106021101031,8 15 Blue-grey7000703170117544754575462,1 14 Pale greenNot available601960213313443452,4 13 Purple40014005Not available666667668Table A.1 (continued)4 ISO 2016 All rights reservedBS EN ISO 6009:2016ISO 6009:2016(E)Desig
42、nated metric size mmGauge Colour RAL referencePantone reference2,7 12 Pale blue501550125024285 C12925 C17454 C13 11 Green-yellowNot available6018Not available3673683693,4 10 Olive brown6007600860155545535605RAL Colour palette: RAL CLASSIC Colour palette K5, Edition 2012 used for definition in ISO 60
43、09 Two other colour palettes available from RAL were not taken into consideration: RAL EFFECT Colour palette E2, Edition 2007 RAL DESIGN Colour palette D2, Edition 2013Manufacturer: RAL gemeinntzige GmbH Siegburger Strae 39 53757 Sankt Augustin Germany Telephone (within Germany): 0 22 41 2 55 16 30
44、Telephone (international): +49 (0) 22 41 2 55 16 60 Fax: + 49 (0) 22 41 2 55 16 - 16 E-Mail: RAL-ColoursRAL-gGmbH.dePantone colour palette:PANTONE COLOR BRIDGE uncoated PANTONE COLOR BRIDGE coatedManufacturer: Pantone LLC 590 Commerce Boulevard Carlstadt, New Jersey 07072-3098 USA Tel: 201-935-5500
45、Fax: 201-896-0242 E-Mail: Web: Table A.1 (continued) ISO 2016 All rights reserved 5BS EN ISO 6009:2016ISO 6009:2016(E)Bibliography1 ISO 7864, Sterile hypodermic needles for single use Requirements and test methods2 ISO 9626, Stainless steel needle tubing for the manufacture of medical devices Requi
46、rements and test methods3 ISO/TR 19244, Guidance on transition periods for standards developed by ISO/TC 84 Devices for administration of medicinal products and catheters6 ISO 2016 All rights reservedBS EN ISO 6009:2016This page deliberately left blankThis page deliberately left blankBSI is the nati
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