BS ISO 13779-6:2015 BSl Standards Publication Licensed copy:IPLogin,Universityof Oxford,Versioncorrectasof Implants for surgery - Hydroxyapatite Part 6: Powders bsi. ..making excellence a habit.. BSISO13779-6:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of ISO 13779-6:2015. The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. @The British Standards Institution 2015.Published by BSI Standards Limited2015 ISBN9780580798825 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Amendments issued since publication Date Textaffected BS ISO 13779-6:2015 INTERNATIONAL ISO STANDARD 13779-6 First edition 2015-01-15 Implants for surgery - Hydroxyapatite - Part 6: Powders Implants chirurgicaux - Hydroxyapatite - Partie 6: Poudres Reference number IS0 13779-6:2015(E) ISO @ISO2015 BSISO13779-6:2015 IS013779-6:2015(E) COPYRIGHTPROTECTEDDOCUMENT @IS02015 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 [email protected] Web www.iso.org Published in Switzerland ii ISO2015-Allrightsreserved BSISO13779-6:2015 IS0 13779-6:2015(E) Contents Page Foreword ..iv Introduction. .. 1 Scope. 2 Normativereferences 3 Terms and definitions 4 .3 Requirements 4.1 General. .3 .3 4.2 Calciumtophosphorusmolarratio (Ca/P) 4.3 Trace elements .3 4.4 Qualitative and quantitative determination of foreign phases .4 4.5 Powdermorphology .5 4.6 Granulometry 4.7 Calcination loss. .5 5 Manufacturing designrequirement .5 6 Certificateofcompliance ..5 AnnexA (informative)Otherpossiblecharacterizationtests .7 Bibliography .9 @ IS0 2015 - All rights reserved ili BSISO13779-6:2015 IS013779-6:2015(E) Foreword Iso (the International Organization for Standardization) isa worldwidefederation of national standards bodies (Iso member bodies). The work of preparing International Standards is normally carried out through Iso 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. Iso collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISo/IEc Directives, Part 1. In particular the different approval criteria needed for the different types of Iso documents should be noted.This document was drafted in accordance with the editorial rules oftheISo/IECDirectives, Part2 (seewww.iso.org/directives) Attention isdrawntothepossibilitythat some ofthe elements of this document maybethesubject of se patent rights.IsO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the Iso list of patent declarations received (see www.iso.org/patents) Any trade name used in this document is information given for the convenience of users and does not constituteanendorsement. JOI Fo