ISO INTERNATIONAL STANDARD 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators Appareils électromedicaux Partie 2-12: Exigences particulieres relatives a la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs Reference number IEC IS0 80601-2-12:2023(E) ISO IS02023 IS0 80601-2-12:2023(E) COPYRIGHT PROTECTED DOCUMENT @IS02023 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 or IsoO'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 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2023 - All rights reserved IS0 80601-2-12:2023(E) @ Contents Foreword Introductiol 201.1 Scope, object and related standards. 201.1.1 Scope. 201. 1.2 0bject.. .3 201. 1.3 Collateral standards.. 201. 1.4 Particular standards.. 201.2 Normative references. .4 201.3 Terms and definitions... ....6 201.4 General requirements.. ...25 201.5 General requirements for testing of ME equipment... 201.6 Classification of ME equipment and ME systems.... 201.7 ME equipment identification, marking and documents ... 201.8 Protection against electrical hazards from ME equipment..... 201.9 Protection against mechanical hazards of ME equipment and ME systems 37 201.10 Protection against unwanted and excessive radiation hazards.... ....41 201.11 Protection against excessive temperatures and other hazards .. ...41 201.12 Accuracy of controls and instruments and protection against hazardous outputs ....45 201.12.1 Accuracy of controls and instruments.. ...45 2o1. 13 Hazardous situations and fault conditions for ME equipment....... .....63 201. 14 Programmable electrical medical systems (PEMS).. ...65 201. 15 Construction of ME equipment. ...66 201.16 ME systems.. .70 201. 17 Electromagnetic compatibility of ME equipment and ME systems... ...70 201. 101 Gas connections..... 201. 102 Requirements for the VBs and accessories... 201. 103 Spontaneous breathing during loss of ventilation ... 20i. i04 indication of duration of operation.. ..76 201.105 Functional connection ...77 201. 106 Display lo0ps. 77 201. 107 Timed ventilatory pause .78 202 Electromagnetic disturbances - Requirements and tests.. ..80 206 Usability .81 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems... .83 Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems .86 @ IS0 2023 - All rights reserved ii IS0 80601-2-12:2023(E) Annex D (informative) Symbols on marking.. .92 Annex AA (informative) Particular guidance and rationale.... .94 Annex BB (informative) Data interfaces ... 134 Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances.. .143 Annex DD (informative) Reference to the essential principles ... .146 Bibliography.... ..149 Alphabetized index of defined terms.. .154 iv @ IS0 2023 - All rights reserved IS0 80601-2-12:2023(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 by the respective organization to deal with particular fields of technical activity. ISo and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with IsO and IEC, also take part in the work. The procedures us