SIST EN ISO 11499:2014
(Main)Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
ISO 11499:2014 gives specific performance requirements for single-use dental cartridges of 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics.
ISO 11499:2014 specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes. Labelling requirements are also specified.
Zahnheilkunde - Zylindrampullen für Lokalanästhetika zum Einmalgebrauch (ISO 11499:2014)
Diese Internationale Norm beschreibt spezifische Leistungsanforderungen an dentale Zylinderampullen zum Einmalgebrauch für Lokalanästhetika mit einem Nennvolumen von 1,0 ml, 1,7 ml, 1,8 ml und 2,2 ml.
Darin werden Prüfungen auf Auslaufsicherheit, zur Kolbenbeweglichkeit, zum extrahierbaren Volumen sowie auf Unterfüllung festgelegt; die allgemeinen Gesamtmaße werden aufgelistet um sicherzustellen, dass die Zylinderampulle in eine dentale Ampullenspritze, die ISO 9997 und ISO 21533 erfüllt, passt.
Anforderungen an die Kennzeichnung werden ebenfalls festgelegt.
ANMERKUNG In den Literaturhinweisen werden Internationale Normen für bestimmte Komponenten von Zylinder-ampullen aufgelistet.
Médecine bucco-dentaire - Cartouches à usage unique pour anesthésiques locaux (ISO 11499:2014)
L'ISO 11499:2014 spécifie des exigences spécifiques de performance relatives aux cartouches non réutilisables à usage dentaire, d'une capacité nominale de 1,0 ml, 1,7 ml, 1,8 ml et 2,2 ml, pour utilisation avec les anesthésiques locaux.
L'ISO 11499:2014 spécifie les essais relatifs à la détection des fuites, au mouvement du piston, au volume extractible et au remplissage insuffisant, et indique les principales dimensions hors tout permettant de garantir que la cartouche sera adaptée aux seringues à usage dentaire selon. Des exigences d'étiquetage sont également spécifiées.
Zobozdravstvo - Ampule z lokalnim anestetikom za enkratno uporabo (ISO 11499:2014)
Standard EN ISO 11499 podaja posebne zahteve za uporabo zobnih ampul za enkratno uporabo z nominalno kapaciteto 1,0 ml, 1,7 ml, 1,8 ml in 2,2 za uporabo z lokalnimi anestetiki. Podaja preskuse za puščanje, gibanje batov, ekstrabilno prostornino in prenapolnjenost ter navaja splošne dimenzije, ki zagotavljajo, da bo ampula ustrezala dentalnim brizgam za ampule v skladu s standardoma ISO 9997 in ISO 21533. Podane so tudi zahteve za označevanje.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2014
1DGRPHãþD
SIST EN ISO 11499:2007
Zobozdravstvo - Ampule z lokalnim anestetikom za enkratno uporabo (ISO
11499:2014)
Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
Zahnheilkunde - Zylindrampullen für Lokalanästhetika zum Einmalgebrauch (ISO
11499:2014)
Médecine bucco-dentaire - Cartouches à usage unique pour anesthésiques locaux (ISO
11499:2014)
Ta slovenski standard je istoveten z: EN ISO 11499:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.060.01 Zobozdravstvo na splošno Dentistry in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11499
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2014
ICS 11.060.20; 11.040.10 Supersedes EN ISO 11499:2007
English Version
Dentistry - Single-use cartridges for local anaesthetics (ISO
11499:2014)
Médecine bucco-dentaire - Cartouches à usage unique Zahnheilkunde - Zylinderampullen zum Einmalgebrauch für
pour anesthésiques locaux (ISO 11499:2014) Lokalanästhetika (ISO 11499:2014)
This European Standard was approved by CEN on 22 May 2014.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11499:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11499:2014) has been prepared by Technical Committee ISO/TC 106 "Dentistry" 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 December 2014, and conflicting national standards shall be withdrawn
at the latest by December 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11499:2007.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11499:2014 has been approved by CEN as EN ISO 11499:2014 without any modification.
INTERNATIONAL ISO
STANDARD 11499
Third edition
2014-06-01
Dentistry — Single-use cartridges for
local anaesthetics
Médecine bucco-dentaire — Cartouches à usage unique pour
anesthésiques locaux
Reference number
ISO 11499:2014(E)
©
ISO 2014
ISO 11499:2014(E)
© ISO 2014
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
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO 11499:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 1
4.1 Freedom from leakage of anaesthetic solution . 1
4.2 Force needed for plunger movement . 2
4.3 Size of air bubble . 2
4.4 Biocompatibility . 2
4.5 Extractable volume . 2
4.6 External dimensions of the assembled cartridge . 2
4.7 Colour coding . 2
5 Test methods . 4
5.1 Sampling . 4
5.2 Test conditions . 4
5.3 Visual inspection . 4
5.4 Cartridge leakage . 4
5.5 Force needed for plunger movement . 5
5.6 Size of air bubble . 6
5.7 Extractable volume . 7
6 Marking . 7
6.1 Primary container . 7
6.2 Secondary container . 7
Bibliography . 9
ISO 11499:2014(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. 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. 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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
This third edition cancels and replaces the second edition (ISO 11499:2007), which has been technically
revised. The following changes have been made:
a) introduction of smaller cartridges of volume 1,0 ml and 1,7 ml;
b) change in force for leakage test.
iv © ISO 2014 – All rights reserved
ISO 11499:2014(E)
Introduction
The safe and efficient operation of dental cartridges for local anaesthetics depends on their freedom
from leakage, the control of the forces required to initiate and maintain the plunger movement and the
absence of large air bubbles.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazard are not included in this International Standard, but it is recommended that, for the
assessment of possible biological hazards, reference be made to ISO 10993-1 and ISO 7405.
INTERNATIONAL STANDARD ISO 11499:2014(E)
Dentistry — Single-use cartridges for local anaesthetics
1 Scope
This International Standard gives specific performance requirements for single-use dental cartridges of
1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics.
It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general
overall dimensions to ensure that the cartridge will fit dental cartridge syringes complying with
ISO 9997 and ISO 21533.
Labelling requirements are also specified.
NOTE A list of International Standards for certain types of cartridge component is given in the Bibliography.
2 Normative references
The following documents, in whol
...
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