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 - Zylinderampullen zum Einmalgebrauch für Lokalanästhetika (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

Status
Published
Publication Date
03-Jun-2014
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
04-Jun-2014
Completion Date
04-Jun-2014

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SLOVENSKI STANDARD
SIST EN ISO 11499:2014
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
SIST EN ISO 11499:2014 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11499:2014
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SIST EN ISO 11499:2014
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.
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SIST EN ISO 11499:2014
EN ISO 11499:2014 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST EN ISO 11499:2014
EN ISO 11499:2014 (E)
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.

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SIST EN ISO 11499:2014
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SIST EN ISO 11499:2014
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
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SIST EN ISO 11499:2014
ISO 11499:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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 2014 – All rights reserved
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SIST EN ISO 11499:2014
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 2014 – All rights reserved iii
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SIST EN ISO 11499:2014
ISO 11499:2014(E)
Foreword

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bodies (ISO member bodies). The work of preparing International Standards is normally carried out

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