ISO INTERNATIONAL STANDARD 80601-2-84 Second edition 2023-11 Medical electrical equipment Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment Appareils électromédicaux- Partie 2-84: Exigences particulieres relatives a la sécurité de base et aux performances essentielles des ventilateurs utilisés dans I'environnement des services medicaux d'urgence Reference number IEC IS0 80601-2-84:2023(E) OSI @IS02023 IS0 80601-2-84:2023(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 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 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland i @ IS0 2023 - All rights reserved IS0 80601-2-84:2023(E) @ Contents Foreword vi Introduction..... ...viii 201. 1 Scope, object and related standards.. 201.1.1 Scope.... 201.1.2 Object..... 201.1.3 201.1.4 Particular standards .... 201. 2 Normative references. 201. 3 Terms and definitions. 201. 4 General requirements. .23 201.4.3 Essentialperformance.. .23 201.4.3.101 Additional requirements for essential performance. 23 201.4.3.102 201.4.4 Additional requirements for expected service life... 201.4.5 Alternative risk control measures or test methods for ME equipment or ME system.... ..25 201.4.6 ME equipment or ME system parts that contact the patient... .25 201. 4.11.101 Additional requirements for pressurized gas input... 25 201. 4.11.101.10verpressure requirement ... ..25 201. 4.11.101.3Compatibility requirements for pressure regulators .... 201. 5 General requirements for testing of ME equipment.... ..26 201.5.101 Additional requirements for general requirements for testing of ME equipment... 201.5.101.1 EMS ventilator test conditions 27 201.5.101.2 Gas flowrate and leakage specifications... 201.5.101.3 EMS ventilator testing errors. .27 201. 6 Classification of ME equipment and ME systems . 201. 7 ME equipment identification, marking and documents..... 201.7.1.101 Information to be supplied by the manufacturer. ..28 201.7.2.3 Consult accompanying documents..... ...28 201. 7.2.4.101 Additional requirements for accessories. .28 201.7.2.18 External gas source.... ..28 201.7.2.101 Additional requirements for marking on the outside of ME equipment or ME equipment parts.... 201.7.4.2 Control devices ... 201.7.4.3 Units of measurement.. ..30 201.7.4.101 Labelling of units of measurement . .30 201.7.9.2.1 General.... 201.7.9.2.1.101 Additional general requirements .... ...30 201. 7.9.2.2.101 Additional requirements for warnings and safety notices....3o. 201.7.9.2.8.101 Additional requirements for start-up procedure ... 201. 7.9.2.9.101 Additional requirements for operating instructions .... 201.7.9.2.12 Cleaning, disinfection, and sterilization .... ...33 201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used material.... 201. 7.9.3.1.101 Additional general requirements ... ..33 201. 7.9.3.101 Additional requirements for the technical description.... ....34 201. 8 Protection against electrical hazards from ME equipment.... 201. 9 Protection against mechanical hazards of ME equipment and ME systems....34 @ IS0 2023 - All rights reserved ii IS0 80601-2-84:2023(E) 201. 9.4.3.101 Additional requirements for instability from unwanted lateral ..34 201.9.4.4 Grips and other handling devices .. ..35 201. 9.6.2.1.101 Additional requirements for audible acoustic energy. .35 201.10 Protection against unwanted and excessive radiation hazards... 201.11 Protection against excessive temperatures and other hazards..... 201.11.1.2.2 Applied parts not intended to supply heat to a patient.. .