EN ISO 21533:2018

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European Foreword . 3

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.

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
ISO 21533:2018(E)
© 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
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
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ii © ISO 2018 – All rights reserved

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 . 8
ISO 21533:2018(E)
Foreword
ISO (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 interested 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 Commission (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 documents 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 for 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 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 ISO's adherence to the
World Trade Organization (WTO) principles in the 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 technically
revised with the following changes:
— dosage-wheel design was added;
— clarification of reprocessing was added.
It also incorporates the Technical Corrigendum ISO 215
...