BS ISO 12891-1:2015 BSl Standards Publication Retrieval and analysis of surgical implants Part 1: Retrieval and handling bsi. ..making excellence a habit. BSISO12891-1:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of IS0 12891-1:2015. It supersedes BS ISO 12891-1:2011 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/150, Implants for surgery. 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 Limited 2015 ISBN9780580890697 ICS 11.040.40 Compliance with a British Standard cannot confer immunityfrom legal obligations. This British Standard was published under the authority of the StandardsPolicy andStrategyCommitteeon30 June2015. Amendments issued since publication Date Textaffected BS ISO 12891-1:2015 INTERNATIONAL ISO STANDARD 12891-1 Third edition 2015-07-01 Retrieval and analysis of surgical implants - Part 1: Retrieval and handling Retraitetanalysedesimplantschirurgicaux- Partie1:Retraitetmanipulation Reference number ISO 12891-1:2015(E) ISO @ISO2015 BS ISO 12891-1:2015 IS0 12891-1:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2015, Published in Switzerland copy: 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 Licensed the requester. ISo copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 0111 Fax +41 22 749 09 47 [email protected] www.iso.org ii ISO2015-Allrights reserved BSISO12891-1:2015 IS0 12891-1:2015(E) Contents Page Foreword ..iv Introduction ..V 1 Scope. 2 Terms and definitions 3 Method ..2 3.1 Obtainingthe clinical history of the implant andpatient .2 3.2 Pre-explantationchecksandexaminations. ..2 3.3 Collecting the surgical implant .2 .3 3.4 Collectingthetissueandfluidsamples. 3.5 Photographic record of the explantation .3 3.6 Containing and labelling the retrieved surgical implant, tissues, and fluids for future identification. .4 3.7 Cleaning the retrieved surgical implant .4 3.8 Decontaminatingtheretrievedsurgicalimplant .6 3.9 Packaging the retrieved surgical implant, tissues, and fluids for shipment 7 3.10 Use of coolant materials .8 3.11 Labelling ofthepackingmaterials .8 3.12 Documentation tobe supplied with retrieved surgical implants. ..8 3.13 Unpackingfollowingshipment 9 3.14 Cleaningand decontaminationfollowing shipment ..9 Documentation to be maintained during examination, analysis, and storage .9 3.15 4 Analysis of retrieved surroundingtissues and fluids. .9 5 Infection control .9 5.1 General ..9 5.2 Work practices. ..10 5.3 Personalprotectiveequipment .10 5.3.1 General .10 5.3.2 Gloves. .10 5.3.3 Masks, eye protection, and face shields ..10 5.3.4 Gowns,aprons,and otherprotectivebodyclothing .11 5.4 Maintenance of the worksite. .11 5.4.1 Cleaninganddisinfectionofworksites. .11 5.4.2 Protective coverings. .11 5.4.3 Equipment and tools .11 5.4.4 Reusablereceptacles .12 .12 5.4.5 Contaminatedglassware 5.4.6 Reusable items ..12 5.4.7 Contaminated materials ..12 5.5 Human waste disposal ..12 5.6 Special practices ..13 AnnexA (informative)Suggested minimuminformationtobeobtainedfor retrieved surgical implants. .14 Annex B (informative) Generic procedures for the decontamination of surgical implants ..17 AnnexC (informative)Analysestobeperformed on retrieved tissue samplesand fluids ..23 Bibliography .24 @ IS0 2015 - All rights reserved ili BSISO12891-1:2015 IS0 12891-1:2015(E) Foreword /2016 Iso (the I