ISO/TR TECHNICAL REPORT 21954 First edition 2018-07 Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator Reference number IEC IS0/TR21954:2018(E) International Organization for Standardization ndards and Technology 9972181 @IS02018 IS0/TR21954:2018(E) COPYRIGHTPROTECTEDDOCUMENT @IS02018 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 below or Iso's member body in the country of the requester. ISO copyright office CP401·Ch.deBlandonnet8 CH-1214 Vernier, Geneva Phone:+4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ganizationfor Standardization ensee-sShenzhen Inste o tandards anedSogie- All rights reserved rious National Standards Bodies IS0/TR 21954:2018(E) Contents Page Foreword ..V Introduction. ...vi 1 * Scope. 2 Normative references .... 3 Terms and definitions. 4 * Applications of means of ventilation .12 4.1 Critical care VENTILATOR ..12 4.1.1 Appropriate standard ..12 4.1.2 Intended PATIENT ..12 4.1.3 USE ENVIRONMENT 4.1.4 IntendedOPERATOR ..13 4.2 VENTILATORfora VENTILATOR-DEPENDENT PATIENT in the HOME HEALTHCARE ENVIRONMENT ..13 4.2.1 Appropriate standard ..13 4.2.2 Intended PATIENT ..13 4.2.3 USE ENVIRONMENT .14 4.2.4 Intended OPERATOR ..14 4.3 VENTILATORfortheEMERGENCYMEDICALSERVICES ENVIRONMENT ..14 4.3.1 Appropriate standard ..14 4.3.2 Intended PATIENT ..14 4.3.3 USE ENVIRONMENT ..15 4.3.4 IntendedOPERATOR ..15 4.4 HOME HEALTHCARE ENVIRONMENT VENTILATORfor a PATIENT With VENTILATORY INSUFFICIENCY .15 4.4.1 Appropriate standard ..15 4.4.2 Intended PATIENT ..15 4.4.3 USE ENVIRONMENT .16 4.4.4 Intended oPERATOR ..16 4.5 HOME HEALTHCARE ENVIRONMENT VENTILATORfor a PATIENT With VENTILATORY IMPAIRMENT ..16 4.5.1 Appropriate standard .16 4.5.2 IntendedPATIENT ..16 4.5.3 USE ENVIRONMENT ..17 4.5.4 Intended oPERATOR ..17 4.6 Gas-powered emergency resuscitators .17 4.6.1 Appropriate standard .17 4.6.2 IntendedPATIENT .18 4.6.3 USE ENVIRONMENT ..18 4.6.4 Intended oPERATOR. ..18 4.7 OPERATOR-powered resuscitators. ..18 4.7.1 Appropriate standard .18 4.7.2 IntendedPATIENT.. ..18 4.7.3 USE ENVIRONMENT ..18 4.7.4 Intended OPERATOR ..18 4.8 SLEEPAPNOEABREATHING THERAPYEQUIPMENT .18 4.8.1 Appropriate standard .18 4.8.2 Intended PATIENT .18 4.8.3 USE ENVIRONMENT. ..19 4.8.4 Intended OPERATOR ..19 Annex A (informative) Rationale and guidance ..20 Annex B (informative) Comparison of the most important environmental characteristics ..22 Annex C (informative) Applicable standard for the USE ENVIRoNMENT .25 iii icensee=Shenzhen Institute of Standards and Technology 9972181 Not for Resale, 2018/9/30 02:12:20