1、September 2014Translation by DIN-Sprachendienst.English price group 10No 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).I
2、CS 11.060.25!%:“2239829www.din.deDDIN EN ISO 11499Dentistry Single-use cartridges for local anaesthetics (ISO 11499:2014);English version EN ISO 11499:2014,English translation of DIN EN ISO 11499:2014-09Zahnheilkunde Zylinderampullen zum Einmalgebrauch fr Lokalansthetika (ISO 11499:2014);Englische F
3、assung EN ISO 11499:2014,Englische bersetzung von DIN EN ISO 11499:2014-09Mdecine bucco-dentaire Cartouches usage unique pour anesthsiques locaux (ISO 11499:2014);Version anglaise EN ISO 11499:2014,Traduction anglaise de DIN EN ISO 11499:2014-09SupersedesDIN EN ISO 11499:2007-09www.beuth.deIn case o
4、f doubt, the German-language original shall be considered authoritative.Document comprises 15 pages08.14 DIN EN ISO 11499:2014-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11499:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaborat
5、ion with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-23 AA Dentalmedizinische Instrumente. The DIN Standards correspo
6、nding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 7885 DIN EN ISO 7885 ISO 9997 DIN EN ISO 9997 ISO 15223-1 DIN EN ISO 15223-1 ISO 21533 DIN EN ISO 21533 Amendments This standard differs from DIN EN ISO 11499:2007-09 as follows
7、: a) smaller cartridges of 1,0 ml and 1,7 ml nominal capacity have been included in the scope and the corre-sponding maximum permissible overall length has been specified in Subclause 4.6.1; b) the permissible test temperatures (Subclause 5.2) have been changed from (23 2) C to (20 5) C; c) in Subcl
8、ause 5.4 “Cartridge leakage”, the test force to be applied has been changed. Previous editions DIN EN ISO 11499: 1999-08, 2007-09 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 7885, Dentistry Sterile injection needles for single use DIN EN ISO 9997, De
9、ntal cartridge syringes DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 21533, Dentistry Reusable cartridge syringes intended for intraligamentary injections EN ISO 11499June 2014 ICS
10、11.060.20; 11.040.10 Supersedes EN ISO 11499:2007English Version Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014) Mdecine bucco-dentaire - Cartouches usage unique pour anesthsiques locaux (ISO 11499:2014) Zahnheilkunde - Zylinderampullen zum Einmalgebrauch fr Lokalansthetika
11、 (ISO 11499:2014) This European Standard was approved by CEN on 22 May 2014. 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 bibli
12、ographical 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 respons
13、ibility 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 Repub
14、lic 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. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brusse
15、ls 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11499:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContents Page
16、Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms and definitions 5 4 Requirements . 5 4.1 Freedom from leakage of anaesthetic solution 5 4.2 Force needed for plunger movement . 6 4.3 Size of air bubble 6 4.4 Biocompatibility . 6 4.5 Extractable volume 6 4.6 External dimens
17、ions of the assembled cartridge . 6 4.7 Colour coding . 6 5 Test methods 8 5.1 Sampling . 8 5.2 Test conditions . 8 5.3 Visual inspection 8 5.4 Cartridge leakage . 8 5.5 Force needed for plunger movement . 9 5.6 Size of air bubble 10 5.7 Extractable volume 11 6 Marking 11 6.1 Primary container . 11
18、6.2 Secondary container 11 Bibliography 13 2DIN EN ISO 11499:2014-09 EN ISO 11499:2014 (E) ForewordThis document (EN ISO 11499:2014) has been prepared by Technical Committee ISO/TC 106 Dentistry in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.
19、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 December 2014, and conflicting national standards shall be withdrawn at the latest by December 2014. Attention is drawn to the possibility that some
20、 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 11499:2007. According to the CEN-CENELEC Internal Regulations, the national standards organizations o
21、f 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, Net
22、herlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11499:2014 has been approved by CEN as EN ISO 11499:2014 without any modification. “ ”3DIN EN ISO 11499:2014-09EN ISO 11499:2014 (E)Introduct
23、ionThe safe and efficient operation of dental cartridges for local anaesthetics depends on their freedom from leakage, the control of the forces required to initiate and maintain the plunger movement and the absence of large air bubbles.Specific qualitative and quantitative test methods for demonstr
24、ating freedom from unacceptable biological hazard are not included in this International Standard, but it is recommended that, for the assessment of possible biological hazards, reference be made to ISO 10993-1 and ISO 7405.4DIN EN ISO 11499:2014-09 EN ISO 11499:2014 (E) 1 ScopeThis International St
25、andard gives specific performance requirements for single-use dental cartridges of 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics.It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure
26、that the cartridge will fit dental cartridge syringes complying with ISO 9997 and ISO 21533.Labelling requirements are also specified.NOTE A list of International Standards for certain types of cartridge component is given in the Bibliography.2 Normative referencesThe following documents, in whole o
27、r in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 7885, Den
28、tistry Sterile injection needles for single useISO 9997, Dental cartridge syringesISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 21533, Dentistry Reusable cartridge syringes intended for intral
29、igamentary injections3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1cartridge for local anaestheticsdevice containing local anaesthetics designed for use with dental cartridge syringes3.2effective length of the cartrid
30、gethe distance travelled by the plunger that expels the extractable volume3.3extractable volumevolume of anaesthetic solution which can be delivered when the cartridge is used with a dental cartridge syringe and a dental injection needle4 Requirements4.1 Freedom from leakage of anaesthetic solutionT
31、he filled cartridge shall be free from leakage of anaesthetic solution.5DIN EN ISO 11499:2014-09EN ISO 11499:2014 (E)Test in accordance with 5.4.4.2 Force needed for plunger movement4.2.1 The force, F1, to initiate movement of the plunger shall not exceed 30 N.4.2.2 The force, F2, to sustain movemen
32、t of the plunger throughout the effective length shall not exceed 20 N and shall not be less than 2 N.Test in accordance with 5.5.4.3 Size of air bubbleThe air bubble in the cartridge shall not be visible below the rim of the metal cap.Test in accordance with 5.6.4.4 BiocompatibilityComponents of th
33、e cartridge in contact with the anaesthetic solution shall neither react with the anaesthetic solution nor release any substances that may adversely affect the therapeutic effectiveness of the injectable products, including those substances which may exhibit toxic, pyrogenic or haemolytic reactions.
34、 See Introduction for application of other international standards.4.5 Extractable volumeWhen tested, the extractable volume shall not be less than the nominal volume stated in 6.1 b) and 6.2 c).Test in accordance with 5.7.4.6 External dimensions of the assembled cartridge4.6.1 Overall lengthThe max
35、imum overall length of a 1,0 ml cartridge shall be 44,0 mm.The maximum overall length of a 1,7 ml and 1,8 ml cartridge shall be 65,0 mm.The maximum overall length of a 2,2 ml cartridge shall be 77,5 mm.4.6.2 Overall diameter (including label if fitted)The maximum overall diameter shall be 9,0 mm.4.7
36、 Colour coding4.7.1 Use of colour coding shall be at the discretion of the manufacturerColour coding shall be used at the discretion of the manufacturer.If colour coding is used, it shall comply with the following.Two indelible coloured bands (Band 1 and Band 2) shall completely encircle the cartrid
37、ge. Band 1 shall indicate the active anaesthetic ingredient and concentration according to Table 1. Band 2 shall indicate the vasoconstrictor and concentration according to Table 2.See Figure 1.6DIN EN ISO 11499:2014-09 EN ISO 11499:2014 (E) Table 1 Colour coding system for the anaesthetic agent and
38、 the concentration in single-use cartridges for local anaestheticsLocal anaesthetic agent and concentrationColour PMSacolour code2 % Lidocaine Red 185 or 186 or 199 or 2003 % Lidocaine Purple 266 or 2672 % Mepivacaine Brown 477 or 478 or 498 or 4993 % Mepivacaine Tan 406 or 407 or 4083 % Prilocaine
39、Orange 136 or 1374 % Prilocaine Yellow 108 or 109 or 110 or 115 or 1164 % Articaine Gold 871 or 872 or 873 or 874 or 8750,5 % Bupivacaine Blue 300 or 301aPMS = Pantone Matching System.Table 2 Colour coding system for the vasoconstrictor and the concentration in single-use cartridges for local anaest
40、heticsVasoconstrictor and concentra-tionColour PMSacolour codeNo vasoconstrictor White NoneEpinephrine 1:200 000 Yellow108 or 109 or 110 or 115 or 116Epinephrine 1:100 000 to 1:200 000Orange 136 or 137Epinephrine 1:50 000 to 1:100 000Brown 477 or 478 or 498 or 499Epinephrine 1:50 000 Green 347 or 34
41、8 or 355 or 356Levonordefrin Black NoneNor-epinephrine 1:100 000 Tan 406 or 407 or 408Nor-epinephrine 1:25 000 Purple 266 or 267Octapressin (felypressin) Blue 300 or 301aPMS = Pantone Matching System.4.7.2 Positions of colour coding bandsBand 1 shall commence between 8 mm and 20 mm from the plunger
42、end of the cartridge.Band 2 shall commence at (2 0,5) mm from the cartridge disc end of Band 1.7DIN EN ISO 11499:2014-09EN ISO 11499:2014 (E)Dimensions in millimetresKey1 band 1 for coding of concentration of anaesthetic agent2 band 2 for coding of concentration of vasoconstrictor3 cartridge plunger
43、4 disc endFigure 1 Placement of colour coding bands on cartridge4.7.3 Dimensions of colour coding bandsBand 1 shall be (3 0,5) mm in width.Band 2 shall be (1,5 0,5) mm in width.5 Test methods5.1 SamplingTest a sample of 10 cartridges from the same batch.All samples shall pass the test.5.2 Test condi
44、tionsConduct all tests at (20 5) C.5.3 Visual inspectionUse visual inspection at normal visual acuity without magnification.5.4 Cartridge leakage5.4.1 Apparatus5.4.1.1 Test rig, to support the cartridge; a suitable test rig is shown in Figure 2.5.4.2 ProcedureSupport the cartridge to be tested in th
45、e test rig.Apply a test force of 30 N axially to a free-fitting round rod that is in contact with the cartridge plunger.8DIN EN ISO 11499:2014-09 EN ISO 11499:2014 (E) Maintain the force for 1 min and inspect the cartridge for leaks or other failure during this period.Record any evidence of leakage
46、or other failure of the cartridge.Dimensions in millimetresKey1 rod2 shatterproof guard, e.g. acrylic cylinder3 test rig4 cartridge5 baseFigure 2 An example of apparatus for testing cartridges for leakage of local anaesthetic solution5.5 Force needed for plunger movement5.5.1 Apparatus5.5.1.1 Machin
47、e, capable of moving the plunger rod of the syringe at a constant speed of (50 1) mm/min.5.5.1.2 Syringe holder, capable of mounting a dental cartridge syringe, an example is shown in Figure 3.5.5.1.3 Sterile single-use dental injection needle, 0,4 mm 30 mm or 35 mm, in accordance with ISO 7885.5.5.
48、1.4 Dental cartridge syringe, in accordance with ISO 9997.5.5.2 ProcedurePlace the cartridge to be tested in the syringe and attach the needle (5.5.1.3). Mount the loaded syringe (5.5.1.4) in the syringe holder (5.5.1.2). Operate the testing machine (5.5.1.1) at the speed of 50 mm/min and record the
49、 force, F1, required to initiate movement of the plunger, and the force, F2, required to sustain movement of the plunger throughout the effective length.9DIN EN ISO 11499:2014-09EN ISO 11499:2014 (E)Key1 syringe holder2 stop pin3 plunger rod4 plunger5 cartridge6 needle7 vessel8 base, securely fixedFigure 3 Example of apparatus for determining force required for plunger movement of the cartridge5.6 Size of air bubbleHold the cartridge
