EN ISO 11499:1999

Dental cartridges for local anaesthetics (ISO 11499:1997)

Zahnärztliche Zylinderampullen zur Lokalanästhesie (ISO 11499:1997)

Diese Internationale Norm beschreibt spezifische Leistungsanforderungen an zahnärztliche Zylinderampullen mit 1,8 ml und 2,2 ml Nennkapazität, die zum Einmalgebrauch in der Lokalanästhesie vorgesehen sind. Sie beschreibt Prüfmethoden zum Auslaufen, zur Bewegung des Kolbenstopfens, zum extrahierbaren Volumen sowie auf Unterfüllung und listet die wesentlichen Gesamtmaße auf um sicherzustellen, daß die zahnärztlichen Zylinderampullen in die Dental- Ampullenspritzen nach ISO 9997 passen. Anforderungen an die Kennzeichnung werden ebenfalls beschrieben.

Cartouches à usage dentaire pour anesthésiques locaux (ISO 11499:1997)

Dental cartridges for local anaesthetics (ISO 11499:1997)

General Information

• Status: Withdrawn
• Publication Date: 22-Jun-1999
• Withdrawal Date: 30-Jun-2007
• 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: 01-Jul-2007
• Completion Date: 01-Jul-2007
• Ref Project: SIST EN ISO 11499:2000 - Dental cartridges for local anaesthetics (ISO 11499:1997)

Relations

• Replaced By: EN ISO 11499:2007 - Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2007)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11499:2000
01-januar-2000
Dental cartridges for local anaesthetics (ISO 11499:1997)
Dental cartridges for local anaesthetics (ISO 11499:1997)
Zahnärztliche Zylinderampullen zur Lokalanästhesie (ISO 11499:1997)
Cartouches a usage dentaire pour anesthésiques locaux (ISO 11499:1997)
Ta slovenski standard je istoveten z: EN ISO 11499:1999
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 11499:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL IS0
STANDARD 11499
First edition
1997-03-O 1
Dental cartridges for local anaesthetics
Cartouches 2 usage dentaire pour anesthksiques locaux
Reference number
IS0 11499: 1997(E)

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IS0 11499:1997(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0
member bodies). The work of preparing International Standards is normally carried out through lS0 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. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
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.
International Standard IS0 11499 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 4, Dental instruments.
Annex A of this International Standard is for information only.
0 IS0 1997
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 protocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-1211 Geneve 20 l Switzerland
Internet central 63 iso.ch
x.400
c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii

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0 IS0 IS0 11499: 1997(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
IS0 10993-I and IS0 7405.

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INTERNATIONAL STANDARD o IS0 IS0 11499:1997(E)
Dental cartridges for local anaesthetics
1 Scope
This International Standard gives specific performance requirements for single-use dental cartridges for local
anaesthetics of I,8 ml and 2,2 ml nominal capacity.
It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists essential overall
dimensions to ensure that the cartridge will fit dental cartridge syringes complying with IS0 9997.
Labelling requirements are also specified.
NOTE - A list of International Standards for certain types of cartridge component is given in annex A.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to
revision, and parties to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent editions of the standards listed below. Members of IEC and IS0 maintain
registers of currently valid International Standards.
IS0 9997: 1990, Dental cartridge syringes.
IS0 7885: 1996, Sterile, single-use dental injection needles.
3 Requirements
3.1 Freedom from leakage of anaesthetic solution
The filled cartridge shall be free from leakage of anaesthetic solution at the plunger and disc. Tests shall be carried
out in accordance with 4.2 and 4.3.

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0 IS0
IS0 11499: 1997(E)
3.2 Force required for plunger movement
3.2.1 The force Fj to initiate movement of the plunger shall not exceed 30 N.
3.2.2 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 4.4.
3.3 Underfilling of cartridges
The air bubble shall not be visible below the rim of the aluminium cap.
Tests shall be carried out in accordance with 4.1 and 4.51.
3.4 Biocompatibility
Components of the cartridge in contact with the anaesthetic solution shall not release any substances which 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 S
...