ISO INTERNATIONAL STANDARD 26782 First edition 2009-07-15 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans Materiel d'anesthesie et de reanimation respiratoire - Spirometres destines au mesurage des volumes expiratoires forcés chronometres chez les humains Reference number ISO 26782:2009(E) @ ISO 2009 IHSunder Not for Resale ISO 26782:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either isO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 . CH-1211 Geneva 20 Tel. + 4122 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2009 - All rights reserved I without license from IHS Not for Resale ISO 26782:2009(E) Contents Page Foreword. .iv Introduction 1 *Scope 2 Normative references. 3 Terms and definitions. 4 General requirements 4.1 Electrical safety 4.2 Mechanical safety. 5 Identification, marking and documents 5.1 Marking of the scale or display.... 5.2 Legibility of markings ... 5.3 Durability of markings... 5.4 Marking of the spirometer or its packaging.. 6 5.5 Instructions for use ... 5.6 Technical description.. .8 6 *Measurement range. ..8 7 Performance requirements... .8 7.1 Accuracy...... 8 7.2 7.3 Graphical display aspect ratios .. 9 7.4 Volume recording. 7.5 *Start of forced exhalation... 7.6 *End of forced exhalation .... 7.7 Linearity... 7.8 Repeatability 9 7.9 Expiratory impedance. 10 8 Constructional requirements . 10 8.1 Effects of dropping components of a hand-held spirometer or accessory 8.2 Calibration.... .10 8.3 Dismantling and re-assembly 10 9 Cleaning, sterilization and disinfection.. 10 9.1 10 9.2 Spirometer and parts requiring processing before use .... .11 9.3 Spirometer and parts delivered sterile.. 11 10 Biocompatibility. 11 Annex A (informative) Rationale... ..12 Annex B (normative) Testing accuracy, linearity and impedance of spirometers... .16 Annex C (normative) * Defined test profiles... ..20 Annex D (informative) Environmental aspects . .23 Annex E (informative) Reference to the essential principals ... .24 Bibliography.. .26 Alphabetized index of defined terms used in this International Standard .. .27 Copyrght International Organizaionforstandardizalonghts reserved ii se from IHS Not for Resale