ISO INTERNATIONAL STANDARD 80601-2-74 Second edition 2021-07 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment Appareils électromédicaux- Partie 2-74: Exigences particulieres pour la sécurite de base et les performances essentielles des équipements d'humidification respiratoire Reference number IS0 80601-2-74:2021(E) TEC tso @ISO 2021 IS0 80601-2-74:2021(E) COPYRIGHT PROTECTED DOCUMENT @ iS0 2021 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, 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 CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland i @ IS0 2021 - All rights reserved IS0 80601-2-74:2021(E) Contents Page Foreword Introduction. .vii 201.1 Scope, object and related standards.... 201.2 Normative references 201.3 Terms and definitions .. 5 201.4 General requirements .. 201.5 General requirements for testing of ME equipment.. 11 201.6 Classification of ME equipment and ME systems.. .12 201.7 ME eguipment identification, marking and documents.. .13 201.8 Protection against electrical hazards form ME equipment . ..20 201.9 Protection against mechanical hazards of ME equipment and ME systems.... 20 201.10 Protection against unwanted and excessive radiation hazards... ..21 201.11 Protection against excessive temperatures and other hazards. 201.12 Accuracy of controls and instruments and protection against hazardous outputs .24 201.13 Hazardous situations and fault conditions for ME Equipment . .30 201.14 Programmable electrical medical systems (PEMS) . ..31 201.15 Construction of ME equipment... 201.16 MEsystems.. ..32 201.16.2 Accompanying documents of an ME system 201.17 Electromagnetic compatibility of ME equipment and ME systems ... .32 201.101 Breathing system connectors and ports. 201.102 Requirements for the breathing system and accessories... .35 201.103 Liquid container .... 201.104 Functional connection . .36 202 Electromagnetic disturbances - Requirements and tests. 206 Usability.... ..38 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.. .39 211 Requirements for medical electrical equipment and medical electrical systems used inthehomehealthcareenvironment.. Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems.. .40 Annex D (informative) Symbols on marking ... .45 Annex AA (informative) Particular guidance and rationale 47 Annex BB (normative) * Determination of the accuracy of the displayed measured gas temperature.... .64 Annex Cc (normative) * Determination of the humidification output .. .. 66 Annex DD (normative) * Specific enthalpy calculations.. Annex EE (normative) Removable temperature sensors and mating ports.... .73 ..77 @ IS0 2021 - All rights reserved iii IS0 80601-2-74:2021(E) Annex GG (informative) Saturation vapour pressure. Annex HH (informative) Reference to the IMDRF essential principles and labelling guidances.... .81 Annex II (informative) Reference to the essential principles of safety and performance of medical devices in accordance with IS0 16142-1:2016 ... ..85 Annex JJ (informative) Reference to the general safety and performance requirements Annex KK (informative) Terminology - Alphabetized index of defined terms ....91 Bibliography.. ..95 iv IS0 2021 - All rights reserved IS0 80601-2-74:2021(E) Foreword ISso (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO m