ISO INTERNATIONAL STANDARD 13504 First edition 2012-07-15 Dentistry General requirements for in dental implant placement and treatment Médecinebucco-dentaire-Exigencesgenerales relatives aux Reference number ISO 13504:2012(E) LSO Copyright International Organization for Standardization @ISO2012 HS unde ted without license from IHS Not for Resale ISO13504:2012(E) COPYRIGHTPROTECTEDDOCUMENT ISO2012 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 photocopying and microfilm, without permission in writing from either IsO at the address below or IsO's memberbody in the country of therequester. ISO copyright office Case postale 56·CH-1211Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2012 -All rights reserved No reproduction or networking permited without license from IHS Not for Resale ISO13504:2012(E) Contents Page Foreword ..iv Introduction 1 Scope 2 Normativereferences 3 Terms and definitions 2 3.2 Instruments 3.3 Stainless steel. 2 4 Classification.. 3 4.1 Intended usage (application) 3 4.2 Tissue contact. 4.3 Reprocessing 3 5 Intended performance 3 6 Performanceattributes 3 7 Material selection 8 Performanceevaluation 8.1 General 8.2 Pre-clinical evaluation. 4 8.3 Clinical evaluation. 9 Manufacturing 5 9.1 General 5 9.2 Technical documentation .5 10 Reprocessing.. 5 10.1 Products supplied sterile. 5 10.2 Productsprovidednon-sterile 5 10.3 Reprocessinginformation 5 11 Informationtobesuppliedbythemanufacturer 5 11.1 5 11.2 Marking on instruments.. 11.3 Labelling on the package. 6 11.4 Instructions for use... 6 AnnexA (normative)Materialsfoundacceptableforinstrument manufacture. Annex B (informative) Cross-referencing of steel grades specified in international, regional or nationalstandards.. 13 Bibliography 15 ili license from IHS Not for Resale