EN ISO 21533-2018 en Dentistry - Reprocessable cartridge syringes for intraligamentary injections.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Reprocessable cartridge syringes for intraligamentary injectionsBS EN ISO 21533:2018National forewordThis British Standard is the UK implementation of EN ISO 21533:2018. It is identical to ISO 21533:2018. It

2、 supersedes BS EN ISO 21533:2003, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on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 pur

3、port to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 92759 1ICS 11.060.20Compliance with a British Standard cannot confer immunity from legal obligat

4、ions. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 21533:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21533January 2018

5、ICS 11.060.20 Supersedes EN ISO 21533:2003, EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 21533:2018: EAll rights of exploitation in any form and by any means

6、 reserved worldwide for CEN national MembersDentistry - Reprocessable cartridge syringes for intraligamentary injections (ISO 21533:2018)Mdecine bucco-dentaire - Seringues cartouche pour injections intraligamentaires, pouvant tre retraites (ISO 21533:2018)Zahnheilkunde - Wiederaufbereitbare Zylinder

7、ampullenspritzen fr intraligamentale Injektionen (ISO 21533:2018)This European Standard was approved by CEN on 7 December 2017.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

8、without any alteration. Up-to-date lists and bibliographical 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 oth

9、er language made by translation under the responsibility 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,

10、Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English

11、 VersionEN ISO 21533:2018 (E)European ForewordThis document (EN ISO 21533:2018) has been prepared by Technical Committee ISO/TC 106 “ Dental instruments“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.This European Standard shall be given the

12、status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 2018, and conflicting national standards shall be withdrawn at the latest by July 2018.Attention is drawn to the possibility that some of the elements of this document may be the subjec

13、t of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 21533:2003.This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association.According to the CEN-CENELEC

14、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 Republic of Macedonia, France, Germany, Greece, Hungary, Icelan

15、d, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 21533:2018 has been approved by CEN as EN ISO 21533:2018 without any modifi

16、cation.2BS EN ISO 21533:2018ISO 21533:2018(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 Design . 24.2 Barrel . 34.2.1 General 34.2.2 Loading of the cartridge 34.3 Threaded needle-mounting hub 44.4 Plunger rod . 44.5 Volume of local anaesthetic delive

17、red. 44.6 Protective sleeve 44.6.1 Number of uses . 44.6.2 Integrity . 44.7 Resistance to reprocessing . 44.7.1 Syringe 44.7.2 Protective sleeve (if supplied) 45 Test methods . 45.1 Visual inspection . 45.2 Measurement of volume delivered 55.2.1 Pistol- and pen-grip designs 55.2.2 Dosage-wheel desig

18、n . 55.2.3 Record of results 55.3 Protective sleeve dislodgement 55.4 Resistance to reprocessing . 56 Instructions for use . 57 Marking 67.1 Marking of unit pack 67.2 Marking of syringe . 6Annex A (informative) Imperial thread sizes 7Bibliography 8 ISO 2018 All rights reserved iiiContents PageBS EN

19、ISO 21533:2018ISO 21533:2018(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interes

20、ted 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 C

21、ommission (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 the different approval criteria needed for the different types of ISO document

22、s 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 document may be the subject of patent rights. ISO shall not be held responsible f

23、or 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/patents).Any trade name used in this document is information given for the

24、convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the

25、 Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This second edition cancels and replaces the first edition (ISO 21533:2003), which has been technical

26、ly revised with the following changes: dosage-wheel design was added; clarification of reprocessing was added.It also incorporates the Technical Corrigendum ISO 21533:2003/Cor.1:2009.iv ISO 2018 All rights reservedBS EN ISO 21533:2018Dentistry - Reprocessable cartridge syringes for intraligamentary

27、injections1 ScopeThis document specifies requirements and test methods for reprocessable cartridge syringes intended for intraligamentary injections.It specifies requirements for cartridge syringes with ISO metric thread sizes, and only intended for intraligamentary injections. However, attention is

28、 drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited

29、applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 7885, Dentistry Sterile injection needles for single useISO 9997, Dental cartridge syringesISO 11499, Dentistry Single-use cartridges for local anaesthe

30、tics3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online

31、 browsing platform: available at https:/www.iso.org/obp3.1intraligamentary injectioninjection made via the periodontal ligament3.2reprocessable cartridge syringe for intraligamentary injectionssyringe which can be reprocessed and is specifically designed by the manufacturer for intraligamentary inje

32、ctions and uses a local anaesthetic cartridge3.3plunger rodrigid component which transmits the activating force to the cartridge plunger3.4levercomponent which delivers the force to the plunger rodINTERNATIONAL STANDARD ISO 21533:2018(E) ISO 2018 All rights reserved 1BS EN ISO 21533:2018ISO 21533:20

33、18(E)3.5dosage wheelpart of the syringe system that regulates the volume of solution delivered by using a rotating wheel3.6dosage-wheel designcartridge syringe where the plunger rod is activated by a dosage wheel3.7protective sleevecomponent which prevents pieces of a fractured cartridge leaving the

34、 syringe through the viewing port3.8unit packpack which contains the syringe4 Requirements4.1 DesignThe design of the cartridge syringe shall be as shown in Figures 1 to 3 of aa) pistol-grip design,b) pen-grip design, orc) dosage-wheel design.Key1 threaded needle-mounting hub2 barrel3 lever4 plunger

35、 rodFigure 1 Pistol-grip design2 ISO 2018 All rights reservedBS EN ISO 21533:2018ISO 21533:2018(E)Key1 threaded needle-mounting hub2 barrel3 leverFigure 2 Pen-grip designKey1 threaded needle-mounting hub2 barrel3 plunger rod4 dosage-wheel5 freely accessible area of the dosage-wheel for the activatio

36、n processFigure 3 Dosage-wheel design4.2 Barrel4.2.1 GeneralThe dimensions of the barrel shall conform to ISO 9997.4.2.2 Loading of the cartridge4.2.2.1 Syringes without viewing portsWhen a viewing port is not present, the dimensions of the barrel shall permit the loading of a cartridge which confor

37、ms to ISO 11499.4.2.2.2 Syringes with viewing portsWhen a viewing port is present, the dimensions of the barrel shall permit the placement of a protective sleeve and shall permit the loading of a cartridge which conforms to ISO 11499. ISO 2018 All rights reserved 3BS EN ISO 21533:2018ISO 21533:2018(

38、E)4.3 Threaded needle-mounting hubThe dimensions of the threaded needle-mounting hub shall conform to ISO 9997.4.4 Plunger rodThe diameter of the plunger rod tip shall conform to ISO 9997. The length of the plunger rod shall allow maximum travel of the cartridge plunger.The maximum sideways displace

39、ment of the plunger rod shall conform to ISO 9997.Test according to 5.1.4.5 Volume of local anaesthetic deliveredThe volume of local anaesthetic delivered at each depression of the lever or appropriate rotation of the dosage-wheel shall be within 10 % of the volume claimed by the manufacturer.Test a

40、ccording to 5.2.4.6 Protective sleeve4.6.1 Number of usesThe protective sleeve, if supplied, shall be either single-use or capable of reprocessing.Test according to 5.3.4.6.2 IntegrityThe protective sleeve shall retain its integrity during use.Test according to 5.3.4.7 Resistance to reprocessing4.7.

41、1 SyringeThe syringe shall comply with the requirements of 4.2, 4.3, 4.4, 4.5, and in addition shall show no signs of corrosion after 100 reprocessing cycles when tested in accordance with 5.4.If the manufacturer states a maximum number of reprocessing cycles less than 100 this maximum number shall

42、be used instead.4.7.2 Protective sleeve (if supplied)If the manufacturer states that the protective sleeve can be reprocessed there shall be no visible signs of deterioration and it shall comply with the requirements of 4.6.2 after 100 reprocessing cycles when tested in accordance with 5.4.If the ma

43、nufacturer states a maximum number of reprocessing cycles less than 100 this maximum number shall be used instead.5 Test methods5.1 Visual inspectionConduct visual inspection at normal visual acuity without magnification.4 ISO 2018 All rights reservedBS EN ISO 21533:2018ISO 21533:2018(E)5.2 Measurem

44、ent of volume deliveredPrepare the syringe with a glass dental local anaesthetic cartridge conforming to ISO 11499 and a needle conforming to ISO 7885.5.2.1 Pistol- and pen-grip designsDepress the lever a sufficient number of times for anaesthetic to be delivered through the needle.When the anaesthe

45、tic delivery is ensured, depress the lever three more times and measure the volume of anaesthetic delivered during each depression. Ensure that the lever returns to its initial position after each depression.5.2.2 Dosage-wheel designRotate the dosage-wheel such that the nominal volume marked on the

46、syringe is delivered, and ensure anaesthetic is being delivered.When the anaesthetic delivery is ensured, measure the volume delivered for three further successive deliveries.5.2.3 Record of resultsRecord the volume of anaesthetic delivered for each test delivery.5.3 Protective sleeve dislodgementPr

47、epare the syringe for use as described in 5.2. After anaesthetic delivery is ensured remove the needle and squeeze the lever until the cartridge breaks. Check by visual inspection if the protective sleeve is intact and not damaged.5.4 Resistance to reprocessingCarry out 100 reprocessing cycles in ac

48、cordance with the manufacturers instructions. The reprocessing cycle shall include the manufacturers recommended methods of cleaning, disinfection and sterilization.Assess visually for any signs of deterioration as in 5.1. Repeat the tests for 4.2, 4.3, 4.4 and 4.5 for the syringe and 4.6.2 for the

49、protective sleeve.If the manufacturer states a maximum number of reprocessing cycles less than 100 use this number of cycles for the test.6 Instructions for useEach syringe shall be accompanied by the following information:a) indications for use;b) information concerning the mechanical advantage produced by the lever;c) the recommended cartridge size and material;d) method of assembly and disassembly;e) method of inserting the cartridge and attaching the needle;f) a statement directing the user to check before use that the barrel and ha