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

ISO 21533:2018 specifies requirements and test methods for reprocessable cartridge syringes intended for intraligamentary injections.
ISO 21533:2018 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
Withdrawn
Publication Date
29-Apr-2018
Withdrawal Date
30-Jul-2018
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
31-Jan-2018
Completion Date
31-Jan-2018

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 21533:2018
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 21533:2018
EN ISO 21533:2018 (E)
Contents Page

European Foreword ...................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
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.

---------------------- Page: 5 ----------------------
SIST EN ISO 21533:2018
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2018 – All rights reserved
---------------------- Page: 8 ----------------------
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 .......................................................................................................................................................................................................................

...

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