SIST EN ISO 21533:2003

Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO 21533:2003)

ISO 21533:2003 specifies requirements and test methods for reusable cartridge syringes intended for intraligamentary injections.
It specifies requirements for dental cartridge syringes only with ISO metric thread sizes, and only intended for intraligamentary injections. However, imperial thread sizes are considered in an informative annex.

Zahnheilkunde - Wiederverwendbare Ampullenspritzen für intraligamentale Injektionen (ISO 21533:2003)

Diese Internationale Norm legt Anforderungen an und Prüfverfahren für wiederverwendbare Ampullenspritzen fest, die für intraligamentale Injektionen vorgesehen sind.
Sie legt Anforderungen an dentale Ampullenspritzen, die nur für intraligamentale Injektionen vorgesehen sind, mit metrischem Gewinde nach ISO fest. Es wird darauf hingewiesen, dass es eine Anzahl von Spritzen mit nichtmetrischem Gewinde gibt (siehe Anhang A).

Art dentaire - Seringues réutilisables destinées aux injections intraligamentaires (ISO 21533:2003)

L'ISO 21533:2003 fixe les exigences et les méthodes d'essai applicables aux seringues à carpule réutilisables destinées aux injections intraligamentaires.
Elle spécifie les exigences relatives aux seringues à carpule à usage dentaire ayant un filetage à pas métrique ISO et uniquement destinées aux injections intraligamentaires. Cependant, l'attention du lecteur est attirée sur l'existence d'un éventail de seringues à filetage en inches dans une annexe informative.

Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO 21533:2003)

Ta evropski standard določa zahteve in preskusne metode za dodatek brizgalke za ponovno intraligamentalno brizganje.

General Information

• Status: Withdrawn
• Publication Date: 31-Aug-2003
• Withdrawal Date: 15-Mar-2018
• ICS: 11.060.20 - Dental equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 16-Mar-2018
• Due Date: 08-Apr-2018
• Completion Date: 16-Mar-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 21533:2003 - Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO 21533:2003)

Relations

• Replaced By: SIST EN ISO 21533:2018 - Dentistry - Reprocessable cartridge syringes for intraligamentary injections (ISO 21533:2018)
• Effective Date: 01-Apr-2018
• Corrected By: SIST EN ISO 21533:2003/AC:2010 - Dentistry - Reusable cartridge syringes intended for intraligamentary injections - Technical Corrigendum 1 (ISO 21533:2003/Cor 1:2009)
• Effective Date: 08-Jun-2022
• Corrected By: SIST EN ISO 21533:2003/AC:2010 - Dentistry - Reusable cartridge syringes intended for intraligamentary injections - Technical Corrigendum 1 (ISO 21533:2003/Cor 1:2009)
• Effective Date: 01-Mar-2010

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO 21533:2003)Zahnheilkunde - Wiederverwendbare Ampullenspritzen für intraligamentale Injektionen (ISO 21533:2003)Art dentaire - Seringues réutilisables destinées aux injections intraligamentaires (ISO 21533:2003)Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO 21533:2003)11.060.20Dental equipmentICS:Ta slovenski standard je istoveten z:EN ISO 21533:2003SIST EN ISO 21533:2003en01-september-2003SIST EN ISO 21533:2003SLOVENSKI
STANDARD



SIST EN ISO 21533:2003



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 21533June 2003ICS 11.060.20English versionDentistry - Reusable cartridge syringes intended forintraligamentary injections (ISO 21533:2003)Art dentaire - Seringues réutilisables destinées auxinjections intraligamentaires (ISO 21533:2003)Zahnheilkunde - Wiederverwendbare Ampullenspritzen fürintraligamentale Injektionen (ISO 21533:2003)This European Standard was approved by CEN on 20 May 2003.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21533:2003 ESIST EN ISO 21533:2003



EN ISO 21533:2003 (E)2CORRECTED
2003-09-24ForewordThis document (EN ISO 21533:2003) has been prepared by Technical Committee ISO/TC 106"Dentistry" in collaboration with Technical Committee CEN/TC 55 "Dentistry", the secretariat ofwhich is held by DIN.This European Standard shall be given the status of a national standard, either by publication ofan identical text or by endorsement, at the latest by December 2003, and conflicting nationalstandards shall be withdrawn at the latest by December 2003.According to the CEN/CENELEC Internal Regulations, the national standards organizations ofthe following countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland andthe United Kingdom.Endorsement noticeThe text of ISO 21533:2003 has been approved by CEN as EN ISO 21533:2003 without anymodifications.NOTE
Normative references to International Standards are listed in Annex ZA (normative).SIST EN ISO 21533:2003



EN ISO 21533:2003 (E)3Annex ZA(normative)Normative references to international publicationswith their relevant European publicationsThis European Standard incorporates by dated or undated reference, provisions from otherpublications. These normative references are cited at the appropriate places in the text and thepublications are listed hereafter. For dated references, subsequent amendments to or revisions ofany of these publications apply to this European Standard only when incorporated in it byamendment or revision. For undated references the latest edition of the publication referred toapplies (including amendments).NOTE Where an International Publication has been modified by common modifications, indicatedby (mod.), the relevant EN/HD applies.PublicationYearTitleENYearISO 1942-31989Dental vocabulary - Part 3: DentalinstrumentsEN 21942-31993ISO 78852000Sterile dental injection needles forsingle useEN ISO 78852000ISO 99971999Dental cartridge syringesEN ISO 99971999ISO 114991997Dental cartridges for localanaestheticsEN ISO 114991999ISO 134021995Surgical and dental hand instruments- Determination of resistance againstautoclaving, corrosion and thermalexposureEN ISO 134022000SIST EN ISO 21533:2003



SIST EN ISO 21533:2003



Reference numberISO 21533:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO21533First edition2003-06-01Dentistry — Reusable cartridge syringes intended for intraligamentary injections Art dentaire — Seringues
réutilisables destinées aux injections intraligamentaires
SIST EN ISO 21533:2003



ISO 21533:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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SIST EN ISO 21533:2003



ISO 21533:2003(E) © ISO 2003 — All rights reserved iii Contents Page Foreword.iv 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Requirements.2 4.1 Design.2 4.2 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 Protective sleeve dislodgement.4 5.5 Boiling-water test.4 5.6 Autoclave test.4 5.7 Dry-heat test.4 6 Manufacturer’s information.
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