SIST EN ISO 11499:2007
Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2007)
Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2007)
This International Standard gives specific performance requirements for single-use dental cartridges of 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. Labelling requirements are also specified.
Zahnheilkunde - Zylinderampullen für Lokalanästhetika zum Einmalgebrauch (ISO 11499:2007)
Diese Internationale Norm gibt spezifische Anforderungen an die Leistung von dentalen Zylinderampullen zum Einmalgebrauch für Lokalanästhetika mit einer Nennkapazität von 1,8 ml und 2,2 ml an.
In dieser Norm werden Prüfungen auf Auslaufsicherheit, zur Bewegung des Kolbens, zum extrahierbaren Volumen sowie auf Unterfüllung festgelegt und die grundlegenden Gesamtmaße, um sicherzustellen, dass dentale Zylinderampullen in dentale Ampullenspritzen nach ISO 9997 passen, werden aufgelistet.
Anforderungen an die Kennzeichnung werden ebenfalls festgelegt.
ANMERKUNG In den Literaturhinweisen werden weitere Internationale Normen für die Anwendung mit Zylinderampullen aufgelistet.
Art dentaire - Cartouches à usage unique pour anesthésiques locaux (ISO 11499:2007)
L'ISO 11499:2007 donne des exigences spécifiques de performance relatives aux cartouches non réutilisables à usage dentaire, d'une capacité nominale de 1,8 ml et de 2,2 ml, pour utilisation avec les anesthésiques locaux.
Elle spécifie les essais relatifs à la détection des fuites, au mouvement du piston, au volume expulsé 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 l'ISO 9997.
Des exigences d'étiquetage sont également spécifiées dans l'ISO 11499:2007.
Zobozdravstvo - Ampule z lokalnim anestetikom za enkratno uporabo (ISO 11499:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11499:2007
01-september-2007
1DGRPHãþD
SIST EN ISO 11499:2000
Zobozdravstvo - Ampule z lokalnim anestetikom za enkratno uporabo (ISO
11499:2007)
Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2007)
Ta slovenski standard je istoveten z: EN ISO 11499:2007
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 11499:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
EN ISO 11499
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.060.20; 11.040.10 Supersedes EN ISO 11499:1999
English Version
Dentistry - Single-use cartridges for local anaesthetics (ISO
11499:2007)
Art dentaire - Cartouches à usage unique pour Zahnheilkunde - Zylinderampullen für Lokalanästhetika zum
anesthésiques locaux (ISO 11499:2007) Einmalgebrauch (ISO 11499:2007)
This European Standard was approved by CEN on 30 June 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11499:2007: E
worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
EN ISO 11499:2007 (E)
Contents Page
Foreword.3
2
---------------------- Page: 3 ----------------------
EN ISO 11499:2007 (E)
Foreword
This document (EN ISO 11499:2007) 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 January 2008, and conflicting national standards shall be withdrawn at
the latest by January 2008.
This document supersedes EN ISO 11499:1999.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11499:2007 has been approved by CEN as a EN ISO 11499:2007 without any modification.
3
---------------------- Page: 4 ----------------------
INTERNATIONAL ISO
STANDARD 11499
Second edition
2007-07-01
Dentistry — Single-use cartridges for
local anaesthetics
Art dentaire — Cartouches à usage unique pour anesthésiques locaux
Reference number
ISO 11499:2007(E)
©
ISO 2007
---------------------- Page: 5 ----------------------
ISO 11499:2007(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.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2007
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
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 2007 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 11499:2007(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 required for plunger movement. 2
4.3 Underfilling of cartridges . 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 Test for cartridge leakage . 4
5.5 Determination of 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 2007 – All rights reserved iii
---------------------- Page: 7 ----------------------
ISO 11499:2007(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 11499 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
This second edition cancels and replaces the first edition (ISO 11499:1997), which has been technically
revised. The following changes have been made:
a) introduction of a colour coding system for the concentration of the anaesthetic agent in single-use
cartridges for local anaesthetics;
b) introduction of a colour coding system for the concentration of the vasoconstrictor in single-use cartridges
for local anaesthetics.
iv © ISO 2007 – All rights reserved
---------------------- Page: 8 ----------------------
ISO 11499:2007(E)
Introduction
The safe and efficient operation of dental cartridges for local anaesthetics depends on their freedom from
leakage, the control of t
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.