ISO INTERNATIONAL STANDARD 20789 First edition 2018-07 Anaesthetic and respiratory equipment Passive humidifiers Materiel d'anesthésie et de reanimation respiratoire - Humidificateurs passifs Reference number IS0 20789:2018(E) International Organization for Standardization isee=Shenzhen Institute of Standards and Technology 9972181 @IS02018 IS0 20789:2018(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2018 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 01 11 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland Internatinir prganization for Standardization Licensee-Shenzhen nsttute of Standards andecS.e- All rights reserved rious National Standards Bodies Not for Resale, 2018/9/30 02:11:37 No reproduction or networking permitted without license from IH IS0 20789:2018(E) Contents Page Foreword ..V Introduction. ..vi 1 * Scope. 2 Normative references 3 Terms and definitions 4 General requirements for testing ..5 4.1 Water level ..5 4.2 PASSIVE HUMIDIFIER test conditions 4.3 * Gas flowrate and leakage specifications. .6 4.4 * PASSIVE HUMIDIFIER testing errors.. 5 General requirements. ..6 5.1 Mechanical BASIC SAFETY for all PASSIVE HUMIDIFIERS .6 5.1.1 General. 5.1.2 * Requirements for instability from unwanted lateral movement. .6 5.1.3 * Requirements for audible acoustic energy ..7 5.1.4 * Overflow. ..8 5.1.5 * Overpressure requirement. ..8 5.2 Compatibility requirement. .9 5.3 General requirements for mechanical strength .9 6 Identification, marking and ACCoMPANYING DocUMENTATION ..10 6.1 Legibility and durability of markings. .10 6.1.1 Legibility. ..10 6.1.2 Durability 6.2 Markings on the outside of the PASSIVE HUMIDIFIER or its parts ..10 6.2.1 Identification 6.2.2 Additional requirements. .11 6.2.3 Requirements for physiological effects ..12 6.2.4 Requirements for packaging. ..12 6.2.5 Symbols. ..12 6.3 Units of measurement .12 6.4 Instructions for use. .12 6.4.1 Identification .12: 6.4.2 General requirements. .13 6.4.3 * Requirements for warnings and safety notices 6.4.4 Requirements for installation. .14 6.4.5 Requirements for start-up PROCEDURE. ..14 6.4.6 * Requirements for operating instructions .14 6.4.7 Requirements for CLEANING, DISINFECTION, and sTERILIZATION. ..16 6.4.8 Requirements for maintenance .16 6.4.9 Requirements for AccEssoRiEs, supplementary equipment and used materia... 16 6.4.10 Unique version identifier. ..16 6.5 Technical description 17 7 * HUMIDIFICATION OUTPUT. ..17 8 Systems requirements ..17 9 Specific SINGLE FAULT CONDITIONS ..18 10 * CLEANING and DISINFECTION .18 10.1 General. ..18 10.2 Home healthcare environment ..18 11 * BREATHING SYSTEM connectors and ports ..18 11.1 General, ..18 Intenationa oganiaion@sIS218 - All rights reserved iii censee=Shenzhen Insttute of Standards and Technology 9972181 Not for Resale, 2018/9/30 02:11:37