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)
ISO 11499:2007 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 in ISO 11499:2007.
Zahnheilkunde - Zylinderampullen für Lokalanästhetika zum Einmalgebrauch (ISO 11499:2007)
Diese Internationale Norm beschreibt spezifische Anforderungen an die Leistung von zahnärztlichen Zylinder¬ampullen mit einer Nennkapazität von 1,8 ml und 2,2 ml für Lokalanästhetika zum Einmalgebrauch.
In dieser Norm werden Prüfungen auf Auslaufsicherheit, zur Beweglichkeit des Kolbens, zum extrahierbaren Volumen sowie auf Unterfüllung festgelegt. Um sicherzustellen, dass die Zylinderampulle in die dentale Ampullenspritze nach ISO 9997 passt, werden die grundlegenden Gesamtmaße aufgelistet.
Anforderungen an die Kennzeichnung werden ebenfalls festgelegt.
ANMERKUNG In den Literaturhinweisen werden weitere Internationale Normen für die Anwendung mit Zylinder¬ampullen 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword.3
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.
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
ISO 11499:2007(E)
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ii © ISO 2007 – All rights reserved
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 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
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 the forces required to initiate and maintain the plunger movement and the absence of
large air bubbles.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard, but it is recommended that, in assessing possible biological hazards, reference be
made to ISO 10993-1 and ISO 7405.
INTERNATIONAL STANDARD ISO 11499:2007(E)
Dentistry — Single-use cartridges for local anaesthetics
1 Scope
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.
NOTE A list of International Standards for certain types of cartridge component is given in the Bibliography
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 9997, Dental cartridge syringes
ISO 7885, Sterile dental injection needles for single use
ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
cartridges for local anaesthetics
cartridges containing local anaesthetics designed for use with dental cartridge syringes
4 Requirements
4.1 Freedom from leakage of anaesthetic solution
The filled cartridge shall be free from leakage of anaesthetic solution.
Tests shall be carried out in accordance with 5.4.
ISO 11499:2007(E)
4.2 Force required for plunger movement
4.2.1 The force, F , to initiate movement of the plunger shall not exceed 30 N.
4.2.2 The force, F , to sustain movement of the plunger throughout its effective length shall not exceed
20 N and shall not be less than 2 N.
Tests shall be carried out in accordance with 5.5.
4.3 Underfilling of cartridges
The air bubble in the cartridge shall not be visible below the rim of the aluminium cap.
Tests shall be carried out in accordance with 5.6.
4.4 Biocompatibility
Components of the cartridge in contact with the anaesthetic solution shall neither react with the anaesthetic
solution nor release any substances that may adversely affect the therapeutic effectiveness of the injectable
products, including those substances which may exhibit toxic, pyrogenic or haemolytic reactions. See
Introduction for application of other International Sta
...
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