1、BRITISH STANDARD BS EN ISO 21533:2003 Dentistry Reusable cartridge syringes intended for intraligamentary injections ICS 11.060.20 Incorporating corrigenda October 2003 and December 2009 National foreword This British Standard is the UK implementation of EN ISO 21533:2003. It is identical to ISO 215
2、33:2003, incorporating corrigendum December 2009. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental instruments. A list of organizations represented on this subcommittee can be obtained on request to its secretary. This p
3、ublication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. BS EN ISO 21533:2003 This British Standard was published under the authority of the
4、Standards Policy and Strategy Committee on 27 June 2003 BSI 2010 Amendments/corrigenda issued since publication Amd. No. Date Comments 14762 Corrig. No. 1 20 October 2003 Incorporating corrected EN ISO foreword page and adding Annex ZA page 31 March 2010 Implementation of ISO corrigendum December 20
5、09, French title on EN ISO title page amended ISBN 978 0 580 70131 3EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO21533 June2003 ICS11.060.20 Englishversion DentistryReusablecartridgesyringesintendedfor intraligamentaryinjections(ISO21533:2003) ArtdentaireSeringues cartouche rutilisables pour
6、injectionsintraligamentaires(ISO21533:2003) ZahnheilkundeWiederverwendbareAmpullenspritzenfr intraligamentaleInjektionen(ISO21533:2003) ThisEuropeanStandardwasapprovedbyCENon20May2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropean Sta
7、ndardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcerningsuchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra
8、nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusastheofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherland
9、s,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnatio
10、nalMembers. Ref.No.ENISO21533:2003EINESO12:3352003(E) 2 CORRECTED20030924 Foreword Thisdocument(ENISO21533:2003)hasbeenpreparedbyTechnicalCommitteeISO/TC106 “Dentistry“incollaborationwithTechnicalCommitteeCEN/TC55“Dentistry“,thesecretariatof whichisheldbyDIN. ThisEuropeanStandardshallbegiventhestatu
11、sofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbyDecember2003,andconflictingnational standardsshallbewithdrawnatthelatestbyDecember2003. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthis
12、EuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,Switzerlandand theUnitedKingdom. Endorsementnotice ThetextofISO21533:2003hasbeenapprovedbyCENasENISO21533:2003withou
13、tany modifications. NOTENormativereferencestoInternationalStandardsarelistedinAnnexZA(normative). BS EN ISO 21533:2003 EN ISO 21533:2003 (E)ii BS EN ISO 21533:2003 EN ISO 21533:2003 (E) iiiContents Page 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Requirements 2 4.1 Design 2 4.2
14、 Barrel 3 4.3 Threaded needle-mounting hub 3 4.4 Plunger rod 3 4.5 Volume of local anaesthetic delivered 3 4.6 Resistance against corrosion, autoclaving and thermal exposure . 3 5 Test methods. 4 5.1 Visual inspection. 4 5.2 Measurement of volume delivered 4 5.3 Plunger rod displacement 4 5.4 Protec
15、tive sleeve dislodgement 4 5.5 Boiling-water test 4 5.6 Autoclave test 4 5.7 Dry-heat test 4 6 Manufacturers information 4 7 Marking. 5 7.1 Marking of unit pack . 5 7.2 Marking of syringe 5 Annex A (informative) Imperial thread sizes 6 BS EN ISO 21533:2003 EN ISO 21533:2003 (E)INTENRATIONAL TSANDADR
16、 IS:33512 O3002(E)I SO 3002 All irhgts seredevr 1Dentistry Reusable cartridge syringes intended for intraligamentary injections 1 Scope This International Standard specifies requirements and test methods for reusable cartridge syringes intended for intraligamentary injections. It specifies requireme
17、nts for dental cartridge syringes with ISO metric thread sizes, and only intended for intraligamentary injections. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A). 2 Normative references The following referenced documents are indispensab
18、le for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942-3, Dental vocabulary Part 3: Dental instruments ISO 7885, Sterile dental injection needles
19、 for single use ISO 9997, Dental cartridge syringes ISO 11499, Dental cartridges for local anaesthetics ISO 13402, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure 3 Terms and definitions For the purposes of this document, the terms
20、 and definitions given in ISO 1942-3 and the following apply. 3.1 intraligamentary injection injection made by the dentist via the periodontal ligament 3.2 reusable cartridge syringe intended for intraligamentary injections syringe used in dentistry which can be resterilized and is specifically desi
21、gned by the manufacturer for intraligamentary injections and uses a container for local anaesthetics 3.3 unit pack pack which contains the syringe 1 BS EN ISO 21533:2003 EN ISO 21533:2003 (E)ISO 21533:2003(E) 2 I SO 3002 All irhgts seredevr3.4 lever component which delivers the force to the plunger
22、rod 3.5 protective sleeve component which prevents pieces of a fractured cartridge leaving the syringe through the viewing port 4 Requirements 4.1 Design The syringe shall be of either a pistol-grip design or a pen-grip design, as shown in Figure 1. a) Pistol-grip design b) Pen-grip design Key 1 thr
23、eaded needle-mounting hub 2 barrel 3 lever Figure 1 Pistol-grip and pen-grip syringe designs 2 BS EN ISO 21533:2003 EN ISO 21533:2003 (E)ISO 21533:2003(E) I SO 3002 All irhgts seredevr 34.2 Barrel 4.2.1 General The dimensions of the barrel shall conform to ISO 9997. 4.2.2 Loading of the cartridge 4.
24、2.2.1 Syringes without viewing ports Where a viewing port is not present, the dimensions of the barrel shall permit the loading of a cartridge which conforms to ISO 11499. 4.2.2.2 Syringes with viewing ports Where a viewing port is present, the dimensions of the barrel shall permit the placement of
25、a protective sleeve and shall permit the loading of a cartridge which conforms to ISO 11499. 4.3 Threaded needle-mounting hub The dimensions of the threaded needle-mounting hub shall conform to ISO 9997. 4.4 Plunger rod The diameter of the plunger rod tip shall be 0 1 6,0 mm. The length of the plung
26、er rod shall allow maximum travel of the cartridge plunger. The maximum sideways displacement of the rod shall not exceed 2 mm in any direction from the long axis of the syringe barrel. Testing shall be carried out in accordance with 5.1 and 5.3. 4.5 Volume of local anaesthetic delivered When tested
27、 in accordance with 5.2, the volume of local anaesthetic delivered at each depression of the lever shall be within 10 % of the volume claimed by the manufacturer. 4.6 Resistance against corrosion, autoclaving and thermal exposure 4.6.1 Syringe The syringe shall function normally and show no signs of
28、 corrosion after the tests in 5.5, 5.6 and 5.7. 4.6.2 Protective sleeve The protective sleeve, if supplied, shall be either single-use or capable of resterilization. Test in accordance with 5.4. If the sleeve is capable of resterilization, it shall fit after testing to 5.5, 5.6 and 5.7 and shall not
29、 become dislodged when tested in accordance with 5.4. 3 BS EN ISO 21533:2003 EN ISO 21533:2003 (E)ISO 21533:2003(E) 4 I SO 3002 All irhgts seredevr5 Test methods 5.1 Visual inspection Visual inspection shall be conducted at normal visual acuity without magnification. 5.2 Measurement of volume delive
30、red Prepare the syringe with a glass dental local anaesthetic cartridge conforming to ISO 11499 and a needle conforming to ISO 7885. Depress the lever completely a sufficient number of times for anaesthetic to be delivered through the needle. Depress the lever three more times and measure the volume
31、 of anaesthetic delivered during each of these three depressions. Ensure that the lever returns to its initial position after each depression. 5.3 Plunger rod displacement Remove the syringe barrel and position the plunger rod fully forward in the syringe. Measure the maximum sideways displacement a
32、t the front end of the plunger rod tip. 5.4 Protective sleeve dislodgement Prepare the syringe for use as described in 5.2. Empty the deliverable contents of the cartridge via the needle. Check for dislodgement of the sleeve during the test. 5.5 Boiling-water test Test the syringe five times as desc
33、ribed in ISO 13402. Visually inspect for compliance with the requirements of 4.6. 5.6 Autoclave test Test the syringe five times as described in ISO 13402. Visually inspect for compliance with the requirements of 4.6. 5.7 Dry-heat test Test the syringe five times as described in ISO 13402. Visually
34、inspect for compliance with the requirements of 4.6. 6 Manufacturers information Each syringe shall be accompanied by the following information: a) indications for use; b) instructions for use; c) information concerning the mechanical advantage produced by the lever; d) the recommended cartridge siz
35、e and material; e) methods of assembly and disassembly; 4 BS EN ISO 21533:2003 EN ISO 21533:2003 (E)ISO 21533:2003(E) I SO 3002 All irhgts seredevr 5f) methods of inserting the cartridge and attaching the needle; g) a statement directing the user to check before use that the barrel and handle are se
36、curely connected and that the interchangeable barrel end cap with needle hub (if fitted) is securely in position; h) the volume of anaesthetic solution delivered per depression of the lever; i) recommended methods of reprocessing for re-use. 7 Marking 7.1 Marking of unit pack Each unit pack shall be
37、 marked with the following information: a) the contents of the pack; b) the name or registered trade mark of the manufacturer; c) the words “syringe intended for intraligamentary injections” or equivalent; d) the classification as a pistol-grip or pen-grip design; e) details of the needle-mounting t
38、hread; f) the size(s) of dental local anaesthetic cartridge(s) to use; g) if a protective sleeve is supplied, an indication of whether the protective sleeve is single-use or can be resterilized; h) if a protective sleeve is not supplied, details of the protective sleeve to be used; i) the lot number
39、. 7.2 Marking of syringe Each syringe shall be indelibly marked with the name or registered trade mark of the manufacturer. 5 BS EN ISO 21533:2003 EN ISO 21533:2003 (E)ISO 21533:2003(E) 6 I SO 3002 All irhgts seredevrAnnex A (informative) Imperial thread sizes Clause 1 mentions the existence of impe
40、rial thread sizes for the needle-mounting threads. In the interests of patient safety, the imperial thread size used should be 0 0,003 0, 216 in () 0 0,08 5,486 mm in 40 TPI (threads per inch) Whitworth form. 6 BS EN ISO 21533:2003 EN ISO 21533:2003 (E)INESO12:3352003(E) 3 AnnexZA (normative) Normat
41、ivereferencestointernationalpublications withtheirrelevantEuropeanpublications This European Standard incorporates by dated or undated reference, provisions from other publications.Thesenormativereferences are cited at the appropriate places in the text and the publicationsarelistedhereafter.Fordate
42、dreferences,subsequentamendmentstoorrevisionsof any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies(includingamendments). NOTEWhereanInternationalPublicationh
43、asbeenmodifiedbycommonmodifications,indicated by(mod.),therelevantEN/HDapplies. Publication Year Title EN Year ISO19423 1989 DentalvocabularyPart3:Dental instruments EN219423 1993 ISO7885 2000 Steriledentalinjectionneedlesfor singleuse ENISO7885 2000 ISO9997 1999 Dentalcartridgesyringes ENISO9997 19
44、99 ISO11499 1997 Dentalcartridgesforlocal anaesthetics ENISO11499 1999 ISO13402 1995 Surgicalanddentalhandinstruments Determinationofresistanceagainst autoclaving,corrosionandthermal exposure ENISO13402 2000 BS EN ISO 21533:2003 EN ISO 21533:2003 (E)BSI Group Headquarters 389 Chiswick High Road, Lon
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