EN 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.
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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

• Status: Withdrawn
• Publication Date: 30-Jun-2007
• Withdrawal Date: 03-Jun-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Jun-2014
• Completion Date: 04-Jun-2014
• Ref Project: SIST EN ISO 11499:2007 - Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2007)

Relations

• Replaces: EN ISO 11499:1999 - Dental cartridges for local anaesthetics (ISO 11499:1997)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11499:2014 - Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
• Effective Date: 08-Jun-2022

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.

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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.

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EN ISO 11499:2007 (E)
Contents Page
Foreword.3

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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.

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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

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ISO 11499:2007(E)
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