DIN EN ISO 6009-2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009 2016) German version EN ISO 6009 2016《一次性使用的皮下注射针 识别用色标(ISO 6009-2016) 德文版本EN IS.pdf

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1、December 2016 English price group 9No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.25!%hJ“2596939www.din.deD

2、IN EN ISO 6009Hypodermic needles for single use Colour coding for identification (ISO 6009:2016);English version EN ISO 6009:2016,English translation of DIN EN ISO 6009:2016-12Medizinische Einmalkanlen Farbcodierung zur Identifizierung (ISO 6009:2016);Englische Fassung EN ISO 6009:2016,Englische ber

3、setzung von DIN EN ISO 6009:2016-12Aiguilles hypodermiques non rutilisables Code de couleurs pour lidentification (ISO 6009:2016);Version anglaise EN ISO 6009:2016,Traduction anglaise de DIN EN ISO 6009:2016-12SupersedesDIN EN ISO 6009:199410 andDIN EN ISO 6009 Corrigendum 1:200808www.beuth.deDocume

4、nt comprises 13 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.12.16 DIN EN ISO 6009:2016-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 6009:2016) has been prepared by Technical Committee

5、ISO/TC 84 “Devices for administration of medicinal products and catheters” (Secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin

6、 (DIN Standards Committee Medicine), Working Committee NA 063-02-01 AA Injektionssysteme. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 7864 DIN EN ISO 7864 ISO 9626 DIN EN ISO 9626 Amendments This standard differs from DIN EN ISO 600

7、9:1994-10 and DIN EN ISO 6009 Corrigendum 1:2008-08 as follows: a) the range of designated needle sizes has been extended to include 0,18 mm; b) the use of instrumentally determined colour zones (chromaticity and luminance index) as described in previous editions to specify opaque colours has been r

8、evised, and it has been decided that instrumental measurement is not practicable; c) Annex A has been revised; d) Annex B has been deleted. Previous editions DIN 13095: 1977-09 DIN EN ISO 6009: 1994-10 DIN EN ISO 6009 Corrigendum 1: 2008-08 National Annex NA (informative) Bibliography DIN EN ISO 786

9、4, Sterile hypodermic needles for single use Requirements and test methods DIN EN ISO 9626, Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6009 August 2016 ICS 11.040.25 Supersedes EN ISO 600

10、9:1994English 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 Stan

11、dard 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

12、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

13、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

14、, Greece, 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 NOR

15、MUNG CEN-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 EForeword . 4Introduction 51 Scope . 62 Terms and definitions . 63 Colour code . 6Annex A (inf

16、ormative) Reference colour samples Bibliography .11Contents PageEN ISO 6009:2016 (E) DIN EN ISO 6009:2016-12 2European foreword .38European 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

17、 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 conflict

18、ing 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 documen

19、t 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 Rep

20、ublic 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 ap

21、proved by CEN as EN ISO 6009:2016 without any modification. EN ISO 6009:2016 (E) DIN EN ISO 6009:2016-12 3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is nor

22、mally 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

23、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 th

24、e 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 docum

25、ent 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 received (see www.iso.org

26、/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 adherence to the WTO pri

27、nciples 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 third edition (ISO 6009:1

28、992), 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 down to 0,18 mm;b) review

29、 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.EN ISO 6009:2016 (E) DIN EN ISO 6009:2016-12 4

30、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 responsibility to check the marked size o

31、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

32、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-coded or to what portion of the needle and

33、/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 complex procedure requiring apparatus and expe

34、rtise 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 compounded in the case of translucent colours

35、, 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 by Pantone Matching System accepting that

36、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.EN ISO 6009:2016 (E) DIN EN ISO 6009:2016-12 5 1 ScopeThis lnternational Standard estab

37、lishes 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 Inter

38、national Standard is not applicable to pen-needles.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1designated metric sizeouter diameter designation of the tubing as defined in Table 1Note 1 to entry: It is expressed in millimetres.2.2gaugelegacy

39、 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 indicate the nominal outer diameter of the tube of the needle and shall be as given in Table 1.Annex A contains certain guidance to comm

40、only 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 White0,3 30 Yellow0,33 29 Red0,36 28 Blue-green0,4 27 Medium grey0,45 26 Brown0,5 25 Orange0,55 24 Medium purpleEN ISO 6009:2016 (E)

41、DIN EN ISO 6009:2016-12 6 Designated metric size mmGauge Colour0,6 23 Deep blue0,7 22 Black0,8 21 Deep green0,9 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)EN ISO 6009

42、:2016 (E) DIN EN ISO 6009:2016-12 7 Annex A (informative) Reference colour samplesTable A.1 Reference colour samplesDesignated metric size mmGauge Colour RAL referencePantone reference0,18 34 Orange20072003200815751571640,2 33 Black900490059017Black 3Black 4Black 60,23 32 Deep green60106001600234834

43、93500,25 31 White9003901090161106011106021101030,3 30 Yellow1018102110231021071090,33 29 Red30173018303117977111870,36 28 Blue-green50095001502030253023090,4 27 Medium grey7047703570444274284290,45 26 Brown8016801780157517751875190,5 25 Orange20072003200815751571640,55 24 Medium purple40014005Not av

44、ailable666667668EN ISO 6009:2016 (E) DIN EN ISO 6009:2016-12 8 Designated metric 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 Cream101

45、4101510014545453545271,2 18 PinkNot available301530141961977011,4 17 Red-violetNot available400640082395240524151,6 16 White9003901090161106011106021101031,8 15 Blue-grey7000703170117544754575462,1 14 Pale greenNot available601960213313443452,4 13 Purple40014005Not available666667668Table A.1 (conti

46、nued)EN ISO 6009:2016 (E) DIN EN ISO 6009:2016-12 9 Designated 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 Colo

47、ur palette K5, Edition 2012 used for definition in ISO 6009 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 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 BRID