EN 29997:1992

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dental cartridge syringes (ISO 9997:1990)Karpulenspritzen in der Zahnheilkunde (ISO 9997:1990)Seringues a usage dentaire pour cartouches (ISO 9997:1990)Dental cartridge syringes (ISO 9997:1990)11.060.20Dental equipment11.040.25Injekcijske brizge, igle in katetriSyringes, needles an cathetersICS:Ta slovenski standard je istoveten z:EN 29997:1992SIST EN 29997:2000en01-januar-2000SIST EN 29997:2000SLOVENSKI
STANDARD



SIST EN 29997:2000



SIST EN 29997:2000



SIST EN 29997:2000



INTERNATIONAL First edition 1990-l 1-o 1 Dental cartridge syringes Scringues 3 usage dentaire pour cartouches Reference number IS0 9997: 1990(E) SIST EN 29997:2000



IS0 9997:1990(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 IS0 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, govern- mental 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 Inter- national Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard IS0 9997 was prepared by Technical Committee ISO/TC 106, Dentistry. 0 IS0 1990 All rights reserved. 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 the publisher. International Organization for Standardization Case Postale 56 l CH-1211 Geneve 20 l Switzerland Printed in Switzerland ii SIST EN 29997:2000



IS0 9997:1990(E) Introduction This international Standard specifies requirements for dental cartridge syringes with IS0 metric threads only. However, attention is drawn to the existence of a variety of syringes with Imperial threads. Manufac- turers currently producing syringes with Imperial threads are requested to change to IS0 metric threads and 1992 has been set as a target date. . . . III SIST EN 29997:2000



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- - - _-----_-_-- --- INTERNATIONAL STANDARD IS0 9997:1990(E) Dental cartridge syringes 1 scope This International Standard specifies requirements and test methods for re-usable dental cartridge syringes of the aspirating, non-aspirating and self- aspirating types for use with dental local anaesthet- its. This Standard does not apply to cartridge syringes having a mechanical-advantage action for creating high pressure. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publi- cation, the editions indicated were valid. All stan- dards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of ap- plying the most recent editions of the standards in- dicated below. Members of EC and IS0 maintain registers of currently valid International Standards. IS0 261: 1973, IS0 general purpose metric screw threads - General plan. IS0 965~1:1980, /SO general purpose metric screw threads - Tolerances - Part I: Principles and basic data. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 aspiration: Process by which blood or body fluid is drawn into an anaesthetic cartridge. 3.2 unit pack: Pack containing a dental cartridge syringe and, where appropriate, adaptors. 4 Requirements 4.1 General 4.1.1 Loading and cartridge size The cartridge shall be capable of being loaded ei- ther from the side or from the back (breech type). The syringe shall permit the appropriate size of local anaesthetic cartridge to be securely held and shall be incapable of being dislodged during use. Testing shall be carried out in accordance with 5.1. 4.1.2 Viewing The syringe shall have two opposed viewing ports so that the solution being injected can be observed. One viewing pot-t shall expose more than half the length of the cartridge and shall be positioned so that the stub-end of the needle is visible during use. Testing shall be carried out in accordance with 5.1. 4.1.3 Needles (and needle mounting) The syringe shall allow needles of diameters up to 0,65 mm to be used. Testing shall be carried out in accordance with 5.1. 4.1.4 Plunger The plunger rod shall be free-moving before and af- ter the tests in 5.4, 5.5 and 5.6. When the rod is pulled fully out of an empty syringe held vertically, the plunger shall be capable of travelling freely and smoothly the whole length under the force of gravity in both vertical directions. The cartridge end of the plunger rod shall contain either a permanently attached tip or a means of se- curing various plunger tips supplied by the manu- facturer of the cartridge syringe. Testing shall be carried out in accordance with 5.1. 1 SIST EN 29997:2000



IS0 9997:1990(E) 4.1.5 Aspirating syringes syringes at any tim shall be e during capable of permitting use. 4.%1.5.1 Syringes in which aspiration is achieved by deflection of diaphragm in cartridge After the test, the reagent (5.2.1) shall have aspi- rated into the cartridge. Testing shall 5.2.2. be carried out in accordance with NOTE 1 Some aspiratinq syringes are intended for use only with cartridges fitted- with specially designed rubber pistons. These syringes rvay ncrt aspirate
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