ISO INTERNATIONAL STANDARD 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement type Sphygmomanometres noninvasifs- Partie 1: Exigences et methodes d'essai pour type a mesurage non automatique Reference number ISO 81060-1:2007(E) ISO IEC @ ISO 2007 THS under Not for Resale ISO 81060-1:2007(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 ISO/IEC2007 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 memberbody 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 2007 - All rights reserved I without license from IHS Not for Resale ISO 81060-1:2007(E) Contents Page Foreword. Introduction .vi 1 *Scope 2 Normative references. 3 Terms and definitions. 4 Identification and marking .. 5 4.1 * Units of measurement... 5 4.2 * Legibility of markings ... 4.3 * Durability of markings...... 4.4 4.5 * Usability of reading .... 4.6 4.7 Marking of the non-automated sphygmomanometer packaging... 5 General requirements for testing non-automated sphygmomanometers 5.1 * Type tests.. 5.2 * Representative sample ... 5.3 Environmental conditions..... 5.4 Repairs and modifications. 5.5 * Humidity preconditioning treatment .... 6 General requirements. 6.1 General...... 8 6.2 Electrical safety...... 6.3 Mechanical safety 8 6.4 Mechanical strength ... 7 Requirements. 10 7.1 Pressure indicating means 10 7.2 Pneumatic system .... 11 7.3 * Tamper proofing or unauthorized access . 14 7.4 Dynamic response in normal use ...... 14 8 Additional requirements for non-automated sphygmomanometer with mercury manometer....... 15 8.1 * Internal diameter of the tube containing mercury 15 8.2 * Portable non-automated sphygmomanometer.. 15 8.3 * Prevention of mercury spillage during transpor.. 15 8.4 * Prevention of mercury spillage in normal use ... 15 8.5 Quality of the mercury... 16 9 Non-automated sphygmomanometers with aneroid manometer .. 9.1 * Scale mark at zero.... 16 9.2 16 9.3 Hysteresis error. 16 9.4 * Construction and materials... 17 10 Cleaning, sterilization and disinfection.. 17 10.1 Reusable non-automated sphygmomanometer and parts. 17 10.2 Non-automated sphygmomanometer and parts requiring processing before use .... 10.3 Non-automated sphygmomanometer and parts delivered sterile .. 18 11 Biocompatibility . Copyrght InternationalOrganizasandardizaoghtsreserved ili se from IHS Not for Resale ISO 81060-1:2007(E) 12 Information supplied by the manufacturer..... 12.1 Accompanying document. ..18 12.2 Instructions for use.. 18 12.3 Technical description . 21 Annex A (informative) Rationale and guidance... 23 Annex B (informative) Advice regarding non-automated sphygmomanometers with a mercury manometer.......... Annex C (informative) Environmental aspects.... Annex D (informative) Reference to the essential principals..... ...33 Annex E (informative) Terminology Alphabetized index of d