ISO INTERNATIONAL STANDARD 80601-2-56 Secondedition 2017-03 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Appareilsélectromédicaux- Partie 2-56:Exigences particulieres relatives a la securite fondamentaleet auxperformances essentiellesdes thermometres medicauxpourmesurerlatemperaturede corps Reference number IEC IS0 80601-2-56:2017(E) tso Intermational Organization for Standardization @ISO2017 STANDARDIZATIONC15956617 IS080601-2-56:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS02017,Published inSwitzerland 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. ISOcopyrightoffice Ch. de Blandonnet 8. CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org Intematinaibr PrganizationfoStandardization Uicensee-ZHEJIANG INSTOF STANDARDIZAoISQ3l.7 -All rights reserved networking permited without license from IHS Notfor Resale, 2017/5/11 01:21:28 IS0 80601-2-56:2017(E) Contents Page Foreword Introduction 201.1 * Scope, object and related standards. 201.1.1 Scope 201.1.2 Object. 201.1.3 Collateral standards. 201.1.4Particular standards .... 201.2 Normative references. 201.3 Terms and definitions. 201.4 General requirements 201.4.2RISK MANAGEMENT PROCESS for ME EQUIPMENT Or ME SYSTEMS 201.4.3 ESSENTIALPERFORMANCE Table 201.101 - Distributed ESSENTIAL PERFORMANCE requirements ... 8 201.5 General requirements fortesting of ME EQUIPMENT .8 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.. 201.7 ME EQUIPMENT identification, marking and documents ... 201.7.9ACCOMPANYING D0CUMENT. 201.8 Protection against electrical HAZARDs from ME EQUIPMENT. 10 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS... ..10 201.10Protection against unwanted and excessive radiation HAzARDs 10 201.11Protection against excessive temperatures and other HAzARDs ... 201.11.7Biocompatibility of ME EQUIPMENT and ME SYSTEMS.. 201.12 Accuracy of controls and instruments and protection against hazardous outputs.. 201.12.1Accuracy of controls and instruments .12 201.12.2 Usability.... ..12 201.13 HAZARDOUS SITUATIONS and fault conditionS... 201.14PROGRAMMABLE ELECTRICALMEDICAL SYSTEMS (PEMS) 12 201.15Construction of MEEQUIPMENT.. .12 201.16ME SYSTEMS 13 201.17Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS... 13 201.101Laboratory performance requirement.. 201.101.1 * General test requirements 13 201.101.2 * LABORATORY ACCURACY, 13 @ IS0 2017 - All rights reserved iii cation for Standardization STANDARDIZATION C1 5956617