ISO INTERNATIONAL STANDARD 18385 Firstedition 2016-02-01 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes Requirements Reduire au maximum le risque de contamination de I'ADN dans les produits utilisés pour recueillir et analyser du materiel biologique en criminalistique -Exigences Reference number IS0 18385:2016(E) ISO @IS0 2016 IS0 18385:2016(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2016, Published in Switzerland 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 Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax+4122749 0947 [email protected] www.iso.org Coovriaht IllIr @ IS0 2016 - All rights reserved IS0 18385:2016(E) Contents Page Foreword ..iv Introduction ..V 1 Scope. .1 2 Terms and definitions .2 3 Abbreviated terms .5 4 Types of products .5 4.1 General, 5 4.2 Products that come into direct contact with biological stains or material potentially containing human DNA 4.3 Chemicals, reagents, solvents, and some disposables involved in the analysis of human DNA 4.4 Protective barrier products that are used during the collection and analysis of biological material 6 5 Quality management systems 6 5.1 General 6 5.2 Documents and records 6 5.3 Authorization 1 5.4 Subcontracting of work and purchase of components 7 5.5 Control of nonconforming product 7 5.6 Corrective and preventive action 8 5.7 Staff contamination detection provision. 8 6 Human DNA contamination risk management 8 6.1 General. .8 6.2 Risk assessment .8 6.3 Risk mitigation .10 6.4 Risk control measures 10 6.4.1 Equipment 10 6.4.2 Personnel 10 6.4.3 Cleaning and maintenance .10 7 Environmental human DNA monitoring .11 8 Requirements for products subject to post-production treatment ..11 9 Requirements for products not subject to post-production treatment ..12 9.1 Product testing .12 9.2 Batch records. .12 10 Product packaging, labelling, and documentation ..12 Annex A (normative) Compliance testing .13 Annex B (informative) Guidance on the effectiveness of post-production treatments currently used in the manufacture of products ..15 Annex C (informative) Relevant markers for DNA profiling ..17 Bibliography .18 ational OraizISShrdzAh rights reserved iii