SIST EN ISO 21533:2018

Dentistry - Reprocessable cartridge syringes for intraligamentary injections (ISO 21533:2018)

This 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 drawn to the existence of a variety of syringes with
imperial thread sizes (see Annex A).

Zahnheilkunde - Wiederaufbereitbare Zylinderampullenspritzen für intraligamentale Injektionen (ISO 21533:2018)

Dieses Dokument legt Anforderungen an und Prüfverfahren für wiederaufbereitbare Zylinderampullenspritzen fest, die für intraligamentale Injektionen vorgesehen sind.
Es legt Anforderungen an Zylinderampullenspritzen mit metrischem ISO-Gewinde fest, die nur für intraligamentale Injektionen vorgesehen sind. Es wird darauf hingewiesen, dass es eine Anzahl von Spritzen mit englischen Gewindegrößen gibt (siehe Anhang A).

Médecine bucco-dentaire - Seringues à cartouche pour injections intraligamentaires, pouvant être retraitées (ISO 21533:2018)

ISO 21533:2018 fixe les exigences et les méthodes d'essai applicables aux seringues à cartouche pour injections intraligamentaires, pouvant être retraitées.
ISO 21533:2018 spécifie les exigences relatives aux seringues à cartouche à filetage métrique ISO, destinées à être utilisées uniquement pour les injections intraligamentaires. Cependant, l'attention du lecteur est attirée sur l'existence d'un éventail de seringues ayant un filetage en inches (voir l'Annexe A).

Zobozdravstvo - Dodatek brizgalke za ponovno intraligamentalno brizganje (ISO 21533:2018)

Ta dokument določa zahteve in preskusne metode za brizgalke za ampule, ki jih je mogoče znova obdelati in so predvidene
za injekcije v ligamente.
Določa zahteve za brizgalke za ampule z velikostmi navojev ISO, ki so namenjene izključno injekcijam v ligamente. Vendar izpostavlja se obstoj različnih brizgalk z imperialnimi velikostmi navojev (glej dodatek A).

General Information

• Status: Published
• Public Enquiry End Date: 19-Feb-2017
• Publication Date: 18-Mar-2018
• ICS: 11.060.20 - Dental equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Feb-2018
• Due Date: 21-Apr-2018
• Completion Date: 19-Mar-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 21533:2018 - Dentistry - Reprocessable cartridge syringes for intraligamentary injections (ISO 21533:2018)

Relations

• Replaces: SIST EN ISO 21533:2003 - Dentistry - Reusable cartridge syringes intended for intraligamentary injections (ISO 21533:2003)
• Effective Date: 01-Apr-2018
• Replaces: 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-Apr-2018
• Replaces: 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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21533:2018
01-april-2018
1DGRPHãþD
SIST EN ISO 21533:2003
SIST EN ISO 21533:2003/AC:2010
Zobozdravstvo - Dodatek brizgalke za ponovno intraligamentalno brizganje (ISO
21533:2018)
Dentistry - Reprocessable cartridge syringes for intraligamentary injections (ISO
21533:2018)
Zahnheilkunde - Wiederaufbereitbare Zylinderampullenspritzen für intraligamentale
Injektionen (ISO 21533:2018)
Médecine bucco-dentaire - Seringues à cartouche pour injections intraligamentaires,
pouvant être retraitées (ISO 21533:2018)
Ta slovenski standard je istoveten z: EN ISO 21533:2018
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 21533:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21533:2018

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SIST EN ISO 21533:2018


EN ISO 21533
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2018
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 21533:2003
English Version

Dentistry - Reprocessable cartridge syringes for
intraligamentary injections (ISO 21533:2018)
Médecine bucco-dentaire - Seringues à cartouche pour Zahnheilkunde - Wiederaufbereitbare
injections intraligamentaires, pouvant être retraitées Zylinderampullenspritzen für intraligamentale
(ISO 21533:2018) 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 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 other 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, 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.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21533:2018 E
worldwide for CEN national Members.

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SIST EN ISO 21533:2018
EN ISO 21533:2018 (E)
Contents Page
European Foreword . 3

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SIST EN ISO 21533:2018
EN ISO 21533:2018 (E)
European Foreword
This 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 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 subject 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 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21533:2018 has been approved by CEN as EN ISO 21533:2018 without any modification.


3

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SIST EN ISO 21533:2018

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SIST EN ISO 21533:2018
INTERNATIONAL ISO
STANDARD 21533
Second edition
2018-01
Dentistry — Reprocessable cartridge
syringes for intraligamentary
injections
Médecine bucco-dentaire — Seringues à cartouche pour injections
intraligamentaires, pouvant être retraitées
Reference number
ISO 21533:2018(E)
©
ISO 2018

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SIST EN ISO 21533:2018
ISO 21533:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2018 – All rights reserved

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SIST EN ISO 21533:2018
ISO 21533:2018(E)

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
4.2.1 General. 3
4.2.2 Loading of the cartridge . 3
4.3 Threaded needle-mounting hub . 4
4.4 Plunger rod . 4
4.5 Volume of local anaesthetic delivered. 4
4.6 Protective sleeve . 4
4.6.1 Number of uses . 4
4.6.2 Integrity . 4
4.7 Resistance to reprocessing . 4
4.7.1 Syringe . 4
4.7.2 Protective sleeve (if supplied) . 4
5 Test methods . 4
5.1 Visual inspection . 4
5.2 Measurement of volume delivered . 5
5.2.1 Pistol- and pen-grip designs . 5
5.2.2 Dosage-wheel design . 5
5.2.3 Record of results . 5
5.3 Protective sleeve dislodgement . 5
5.4 Resistance to reprocessing . 5
6 Instructions for use . 5
7 Marking . 6
7.1 Marking of unit pack . 6
7.2 Marking of syringe . 6
Annex A (informative) Imperial thread sizes . 7
Bibliography .
...