EN ISO 11499-2014 en Dentistry - Single-use cartridges for local anaesthetics《牙科学 局部麻醉用一次性盒(ISO 11499 2014)》.pdf

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1、BSI Standards PublicationBS EN ISO 11499:2014Dentistry Single-use cartridges for local anaestheticsBS EN ISO 11499:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11499:2014. It supersedes BS EN ISO 11499:2007 which is withdrawn.The UK participation in

2、its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.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 necessary provisions of a contract. Users are respons

3、ible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 77619 9ICS 11.040.10; 11.060.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of th

4、e Standards Policy and Strategy Committee on 30 June 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11499 June 2014 ICS 11.060.20; 11.040.10 Supersedes EN ISO 11499:2007English Version Dentistry - Single-use car

5、tridges for local anaesthetics (ISO 11499:2014) Mdecine bucco-dentaire - Cartouches usage unique pour anesthsiques locaux (ISO 11499:2014) Zahnheilkunde - Zylinderampullen zum Einmalgebrauch fr Lokalansthetika (ISO 11499:2014) This European Standard was approved by CEN on 22 May 2014. CEN members ar

6、e 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

7、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 Ce

8、ntre 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, Lithua

9、nia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1

10、000 Brussels 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 EBS EN ISO 11499:2014BS EN ISO 11499:2014EN ISO 11499:2014 (E) 3 Foreword This document (EN ISO 11499:2014) has been prepared by Technical Committee I

11、SO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” 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 December 2014, and co

12、nflicting national standards shall be withdrawn at the latest by December 2014. 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 d

13、ocument supersedes EN ISO 11499:2007. 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 Yugos

14、lav 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 11499:2014 has

15、 been approved by CEN as EN ISO 11499:2014 without any modification. BS EN ISO 11499:2014ISO 11499:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 14.1 Freedom from leakage of anaesthetic solut

16、ion . 14.2 Force needed for plunger movement 24.3 Size of air bubble . 24.4 Biocompatibility 24.5 Extractable volume 24.6 External dimensions of the assembled cartridge 24.7 Colour coding . 25 Test methods . 45.1 Sampling . 45.2 Test conditions 45.3 Visual inspection . 45.4 Cartridge leakage 45.5 Fo

17、rce needed for plunger movement 55.6 Size of air bubble . 65.7 Extractable volume 76 Marking 76.1 Primary container 76.2 Secondary container 7Bibliography 9BS EN ISO 11499:2014ISO 11499:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national stan

18、dards bodies (ISO member bodies). The work of 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 org

19、anizations, 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 of electrotechnical standardization.The procedures used to develop this document and those intended for its

20、 further maintenance are described in the ISO/IEC Directives, Part 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. www.iso.org/directi

21、vesAttention 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 rights. Details of any patent rights identified during the development of the document will be in the Intr

22、oduction and/or on the ISO list of patent declarations received. www.iso.org/patentsAny 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 conform

23、ity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This thir

24、d edition cancels and replaces the second edition (ISO 11499:2007), which has been technically revised. The following changes have been made:a) introduction of smaller cartridges of volume 1,0 ml and 1,7 ml;b) change in force for leakage test.iv ISO 2014 All rights reservedBS EN ISO 11499:2014ISO 11

25、499:2014(E)IntroductionThe 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

26、methods for demonstrating 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. ISO 2014 All rights reserved vBS EN ISO 11499:2014BS EN

27、 ISO 11499:2014Dentistry Single-use cartridges for local anaesthetics1 ScopeThis International Standard 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, plung

28、er movement, extractable volume and underfilling, and lists general overall dimensions to ensure 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

29、 component is given in the Bibliography.2 Normative referencesThe following documents, in whole or 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 r

30、eferenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 7885, Dentistry 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

31、 Part 1: General requirementsISO 21533, Dentistry Reusable cartridge syringes intended for intraligamentary 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 loc

32、al anaesthetics designed for use with dental cartridge syringes3.2effective length of the cartridgethe 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 syr

33、inge and a dental injection needle4 Requirements4.1 Freedom from leakage of anaesthetic solutionThe filled cartridge shall be free from leakage of anaesthetic solution.INTERNATIONAL STANDARD ISO 11499:2014(E) ISO 2014 All rights reserved 1BS EN ISO 11499:2014ISO 11499:2014(E)Test in accordance with

34、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 movement 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

35、 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 the cartridge in contact with the anaesthetic solution shall neither react with the anaesthetic solution nor release any substances that may ad

36、versely affect the therapeutic effectiveness of the injectable products, including those substances which may exhibit toxic, pyrogenic or haemolytic reactions. See Introduction for application of other international standards.4.5 Extractable volumeWhen tested, the extractable volume shall not be les

37、s 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 maximum 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 m

38、aximum 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 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 m

39、anufacturer.If colour coding is used, it shall comply with the following.Two indelible coloured bands (Band 1 and Band 2) shall completely encircle the cartridge. Band 1 shall indicate the active anaesthetic ingredient and concentration according to Table 1. Band 2 shall indicate the vasoconstrictor

40、 and concentration according to Table 2.See Figure 1.2 ISO 2014 All rights reservedBS EN ISO 11499:2014ISO 11499:2014(E)Table 1 Colour coding system for the anaesthetic agent and the concentration in single-use cartridges for local anaestheticsLocal anaesthetic agent and concentrationColour PMSacolo

41、ur 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 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,

42、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 anaestheticsVasoconstrictor and concentra-tionColour PMSacolour codeNo vasoconstrictor White NoneEpinephrine 1:200 000 Yellow108

43、 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 348 or 355 or 356Levonordefrin Black NoneNor-epinephrine 1:100 000 Tan 406 or 407 or 408Nor-epinephrine 1:25 000 Purple 266

44、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 end of the cartridge.Band 2 shall commence at (2 0,5) mm from the cartridge disc end of Band 1. ISO 2014 All rights reserv

45、ed 3BS EN ISO 11499:2014ISO 11499:2014(E)Dimensions in millimetresKey1 band 1 for coding of concentration of anaesthetic agent2 band 2 for coding of concentration of vasoconstrictor3 cartridge plunger4 disc endFigure 1 Placement of colour coding bands on cartridge4.7.3 Dimensions of colour coding ba

46、ndsBand 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 conditionsConduct all tests at (20 5) C.5.3 Visual inspectionUse visual inspection at normal visual acuit

47、y 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 the test rig.Apply a test force of 30 N axially to a free-fitting round rod that is in contact with th

48、e cartridge plunger.4 ISO 2014 All rights reservedBS EN ISO 11499:2014ISO 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 or other failure of the cartridge.Dimensions in millimetresKey1 rod2 shatterproof

49、 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 Machine, 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 7885.5.5.1.4