ISO INTERNATIONAL STANDARD 80601-2-13 Second edition 2022-04 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation Appareils électromédicaux- Partie 2-13: Exigences particulieres de sécurité de base et de performances essentielles pour les postes de travail d'anesthesie Reference number IEC IS0 80601-2-13:2022(E) OSI @IS02022 IS0 80601-2-13:2022(E) COPYRIGHT PROTECTED DOCUMENT @ISO2022 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 on the internet or an intranet, withoutpriorwrittenpermission.Permission can berequestedfrom eitherIso at theaddress below orIso'smemberbodyinthecountryoftherequester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2022 - All rights reserved IS0 80601-2-13:2022(E) Contents Foreword Introduction. vii 201.1 Scope, object and related standards.... 201.2 Normative references. 201.3 Terms and definitions , 201.4 General requirements . 201.5 General requirements for testing ME equipment... 11 201.6 Classification of ME equipment or ME systems. 12 201.7 ME equipment identification, marking and documents. .12 201.8 Protection against electrical hazards from ME equipment.. 17 201.9 Protection against mechanical hazards of ME equipment and ME systems.... 201.10 Protection against unwanted and excessive radiation hazards. .19 201.11 Protection against excessive temperatures and other hazards 19 201.12 Accuracy of controls and instruments and protection against hazardous outputs .. 201.13 Hazardous situations and fault conditions .. ..28 201.14 Programmable electrical medical systems (PEMS). 201.15Construction of ME equipment... 29 201.16ME systems... 201.17Electromagnetic compatibility of ME equipment and ME systems. 31 201.101 Additional requirements for anaesthetic gas delivery systems.. .31 201.102 Additional requirements for an anaesthetic breathing system. ....37 201.103 Additional requirements for an AGSs. 48 201.104 Additional requirements for interchangeable and non-interchangeable anaesthetic vapour delivery systems.. .53 201.105 Additional requirements for an anaesthetic ventilator... 201.106 Display of pressure-volume loops .64 201.107 Clinical evaluation .. ...64 202Electromagnetic disturbances - Requirements and tests . 2o3 General requirements for radiation protection in diagnostic X-ray equipment.. 206Usability. ..65 2o8General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.... ..66 2o9Requirements for environmentally conscious design . .66 21oProcess requirements for the development of physiologic closed-loop controllers.. ..67 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.... @ IS0 2022 - All rights reserved ii IS0 80601-2-13:2022(E) 212Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. ..67 Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems ortheir parts. ..68 Annex D (informative) Symbols on marking .... Annex AA (informative) Particular guidance and rationale . Annex BB (normative) Test for flammability of anaesthetic agent. ...97 Annex CC (informative) Terminology - alphabetized index of defined terms.. Bibliography. 102 iv @ IS0 2022 - All rights reserved IS0 80601-2-13:2022(E) Foreword ISo (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of IsO or I