ISO INTERNATIONAL STANDARD 21533 Second edition 2018-01 Dentistry Reprocessable cartridge syringes for intraligamentary injections Médecine bucco-dentaire - Seringues a cartouche pour injections intraligamentaires, pouvant étre retraitées Reference number IS0 21533:2018(E) osi @IS02018 IS0 21533:2018(E) COPYRIGHT PROTECTED DOCUMENT @ IS0 2018, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form writtenpermission.Permission canberequestedfromeitherIsOattheaddressbelow orIso'smemberbodyinthecountryof the requester. ISO copyrightoffice Ch. de Blandonnet 8 · CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org ii @ IS0 2018 - All rights reserved IS0 21533:2018(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references ..1 3 Terms and definitions 4 Requirements .2 4.1 Design .2 4.2 Barrel. ..3 4.2.1 General 3 4.2.2 Loading of the cartridge 3 4.3 Threaded needle-mounting hub 4 4.4 Plunger rod. .4 4.5 Volume of local anaesthetic delivered 4 4.6 Protective sleeve .4 4.6.1 Number of uses ..4 4.6.2 Integrity 4 4.7 Resistance to reprocessing 4.7.1 Syringe 4.7.2 Protective sleeve (if supplied) .4 5 Test methods. .4 5.1 Visual inspection. 4 5.2 Measurement of volume delivered .5 5.2.1 Pistol- and pen-grip designs 5 5.2.2 Dosage-wheel design 5 5.2.3 Record of results. 5 5.3 Protective sleeve dislodgement .5 5.4 Resistance to reprocessing .5 6 Instructions for use .5 7 Marking. .6 7.1 Marking of unit pack ..6 7.2 Marking of syringe. ..6 Annex A (informative) Imperial thread sizes .7 Bibliography ..8 @ IS0 2018 - All rights reserved iii