ISO INTERNATIONAL STANDARD 80601-2-61 Second edition 2017-12 Corrected version 2018-02 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Appareilsélectromedicaux Partie 2-61: Exigences particulieres pour la sécurite de base et les performancesessentielles pour les oxymetres depouls Reference number IEC IS0 80601-2-61:2017(E) @ISO2017 IS080601-2-61:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS02017 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 below or Iso's member body in the country of the requester. ISO copyright office CP 401 : Ch.de Blandonnet 8 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax+4122 749 09 47 copyright@iso.org www.iso.org Published in Switzerland ii @ IS0 2017 - All rights reserved IS080601-2-61:2017(E) Contents Page Foreword Introduction vi 201.1 Scope, objectand related standards... 201.2 Normative references 201.3Termsanddefinitions.. 201.4 Generalrequirements. 201.5 GeneralrequirementsfortestingofMEEQUIPMENT 10 201.6 Classificationof ME EQUIPMENT andME SYSTEMS... 201.7 ME EQUIPMENTidentification,markingand documents 11 201.8 Protection againstelectrical HAZARDs from ME EQUIPMENT... 15 201.9Protectionagainstmechanical HAZARDS ofMEEQUIPMENTand MESYSTEMS. 201. 10 Protection against unwanted and excessive radiation HAzARDS.. .15 201.11ProtectionagainstexcessivetemperaturesandotherHAzARDs 2o1.12 Accuracy ofcontrols and instruments and protectionagainst hazardous outputs. .17 201.13HAZARDOUSSITUATIONS andfault conditionsfor MEEQUIPMENT ..21 201.14 PROGRAMMABLE ELECTRICALMEDICAL SYSTEMS (PEMS). 21 201.15Construction of ME EQUIPMENT... 21 201.16 ME SYSTEMS.. .23 201.17ElectromagneticcompatibilityofMEEQUIPMENTandMESYSTEMS... ..23 201.101 *PULSEOXIMETERPROBES andPROBECABLEEXTENDERS .23 201.102 Saturation pulse INFORMATION SIGNAL... 201.103 FUNCTIONAL CONNECTION... ..24 202 Electromagnetic disturbances-Requirements and tests.. .24 206 Usability 208 Generalrequirements,testsandguidanceforalarm systems inmedical electricalequipment and medical electrical systems .26 211 Requirementsfor medical electrical equipment and medical electrical systems used in the homehealthcareenvironment.. 212 Requirements formedical electrical equipmentand medical electrical systems usedinthe emergencymedical services environment 27 Annex C (informative) Guide to marking and labellingrequirements for ME EQUIPMENT and ME SYSTEMS....28 Annex D (informative) Symbols on marking... 31 Annex AA (informative)Particular guidance and rationale .32 ..40 AnnexBB(informative)SkintemperatureatthePULSEoxIMETERPRoBE ANNExCC(informative)DeterminationofAccURACY. ..44 AnnexDD (informative)Calibration standards.. .53 Annex EE (informative) Guideline for evaluating and documenting SpO2 AccuRAcY in human subjects.... 54 AnnexFF (informative)SimulatorS,calibrators and FUNCTIONALTESTERS for PULSE OxIMETER EQUIPMENT....61 @ IS0 2017 - All rights reserved ii