ISO INTERNATIONAL STANDARD 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment Appareils électromédicaux- Partie 2-90: Exigences particulieres pour la sécurite de base et les performances essentielles des équipements de thérapie respiratoire d haut débit Reference number TEC IS0 80601-2-90:2021(E) tso @ISO2021 IS0 80601-2-90:2021(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 80601-2-90:2021(E) Contents Foreword Introduction. vi 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 of ME equipment.. .12 201. 6 Classification of ME equipment and ME systems ... .13 201. 7 ME equipment identification, marking and documents . ..13 201. 8 Protection against electrical hazards from ME equipment.... .20 201. 9 Protection against mechanical hazards of ME equipment and ME systems. 201.10 Protection against unwanted and excessive radiation hazards... ..21 201.11 Protection against excessive temperatures and other hazards .22 201.12 Accuracy of controls and instruments and protection against hazardous outputs .... 26 201.13 Hazardous situations and fault conditions for ME equipment... ....33 201.14 Programmable electrical medical systems (PEMS) .. 201.15 Construction of ME equipment. .34 201.16 ME systems..... ..35 201.17 Electromagnetic compatibility of ME equipment and ME systems... 201.101 Gas connections .. .36 201.102 Requirements for the breathing system and accessories... 201.103 * Indication of duration of operation 40 201.104 Functional connection .41 201.105 Power supply cords... 201.106 Respiratory high-flow therapy equipment security . 42 202 Electromagnetic disturbances - Requirements and tests .. .42 206 Usability ..43 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.. .44 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.. ..46 Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems... .48 Annex D (informative) Symbols on marking . .54 Annex AA (informative) Particular guidance and rationale . .55 AA.1 General guidance... .55 @ IS0 2021 - All rights reserved ili IS0 80601-2-90:2021(E) AA.2Rationale for particular clauses and subclauses. .55 Annex BB (informative) Data interface requirements .69 BB.1Background and purpose..... BB.2 Data definition.. ..70 Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances.... 73 Annex DD (informative) Reference to the essential principles ..76 Annex EE (informative) Reference to the general safety and performance requirements.... 79 Annex FF (informative) Terminology - Alphabetized index of defined terms.... iv @ IS0 2021 - All rights reserved IS0 80601-2-90:2021(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 IEC participate in the development of International Standards through technical committees established