ISO INTERNATIONAL STANDARD 8600-1 Fourth edition 2015-10-15 Endoscopes Medical endoscopes and endotherapy devices - Part 1: General requirements Endoscopes - Endoscopes médicaux et dispositifs d'endothérapie - Partie 1: Exigences générales Reference number IS0 8600-1:2015(E) SO International Organization for Standardization ng Institute of Sta @ IS0 2015 Zhejian dardization 5956617 vided by IHS under I Not for Resale, 2015/11/30 07:20:39 ted without license from IHS IS0 8600-1:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2015, 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 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 PrganizationforStandardization Not for Resale, 2015/11/30 07:20:39 etworking permitted without license from IHS IS0 8600-1:2015(E) Contents Page Foreword ..iv 1 Scope 1 2 Normative references 3 Terms and definitions 4 Requirements 5 4.1 General 5 4.2 Surface and edges. .5 4.3 Maximum insertion portion width 55 4.4 Minimum instrument channel width 4.5 Field ofview .5 4.6 Direction of view. .5 4.7 Safety .6 4.8 Biological compatibility. 6 4.9 Fittings/connectors for liquid or gaseous media .6 4.10 Deflection control system for the controllable portion .6 4.10.1 General. ..6 4.10.2 Deflection up and down. .6 4.10.3 Deflection right and left 4.10.4 Arrangement of the hand wheels 6 4.10.5 Maximum angle of deflection .7 5 Testing .7 5.1 General 7 5.2 Surface and edges. .7 5.3 Maximum insertion portion width .1 5.4 Minimum instrument channel width .8 5.5 Field of view .8 5.6 Direction of view .8 6 Marking .8 6.1 Minimum marking ..8 6.2 Marking legibility. 9 6.3 Marking exceptions. 7 Instruction manual .9 8 Packaging ..10 Annex A (informative) Guidelines on the application of risk management to endoscopic system connector. .11 Bibliography. .13 iii see=Zhejiang Institute of Standardization 5956617 vided by IHS under lic vithoutlicense from IHS