ISO INTERNATIONAL STANDARD 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers : Part 2: Clinical investigation of intermittent automated measurement type Sphygmomanometres non invasifs- Partie 2: Investigation clinique pour type ponctuel d mesurage automatique Reference number IEC IS0 81060-2:2018(E) @ IS0 2018 IS0 81060-2:2018(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: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS0 81060-2:2018(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Normative references 3 Terms and definitions 4 General requirements for CLINICAL INVESTIGATIONS .2 4.1 .2 CLINICALINVESTIGATIONmethods 4.2 Good clinical practice. .3 4.3 StatuS of previous CLINICAL INVESTIGATIONS ..3 4.4 Disclosureof summaryof cLINICAL INVESTIGATION ..3 5 CLINICAL INVESTIGATION With an auSCultatoryREFERENCE SPHYGMOMANOMETER. 5.1 Subject requirements. 5.1.1 *Number ..3 5.1.2 * Gender distribution .3 5.1.3 * Age distribution. .4 5.1.4 * Limb size distribution 4 5.1.5 Blood pressure distribution .4 5.1.6 * Special PATIENT populations. .5 5.2 CLINICAL INVESTIGATION method With a REFERENCE SPHYGMOMANOMETER. .5 * Subject preparation.. .5 5.2.1 5.2.2 * Observer preparation .6 5.2.3 * REFERENCE readings. 5.2.4 CLINICAL INVESTIGATION methods 7 5.2.5 * Additional requirements for a SPHYGMOMANOMETER intended for use in exercisestresstestingenvironments. .15 5.2.6 * Additional requirements for a SPHYGMOMANOMETER intended for use in ambulatory monitoring... ..16 6 CLINICALINVESTIGATION WithREFERENCE INVASIVEBLOODPRESSUREMONITORING EQUIPMENT .17 6.1 PATIENT requirements .17 6.1.1 Number .17 6.1.2 * Gender distribution .17 6.1.3 * Age distribution. ..17 6.1.4 Limb size distribution ..18 6.1.5 BLOOD PRESSURE distribution. ..18 6.1.6 Special PATIENT populations .19 6.2 CLINICALINVESTIGATIONmethodsWithREFERENCEINVASIVEBLOODPRESSURE MONITORINGEOUIPMENT ..19 6.2.1 * REFERENCE measurement .19 6.2.2 * Arterial REFERENCE site. .20 6.2.3 PROCEDURE. 20 6.2.4 * Determining the REFERENCE BLOOD PRESSURE 21 6.2.5 Determining the error of the BLOOD PRESSURE measurement .22 6.2.6 Data analysis. .22 6.2.7 MEAN ARTERIALPRESSURE (MAP) ..23 7 * Pregnant PATIENT populations .23 Annex A (informative) Rationale and guidance ..25 AnnexB (informative)Referenceto theESSENTIALPRINCIPLES .33 Annex C (informative) Terminology - alphabetized index of defined terms ..34 Bibliography .35 @ IS0 2018 - All rights reserved iii