ISO/TR TECHNICAL REPORT 19024 First edition 2016-09-01 Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass Evaluation des dispositifs PCP relative a leurs capacités de réduire la transmissiondesmicro-emboliesgazeuses(MEG)aunpatientdurant un pontage cardiopulmonaire Reference number IS0/TR19024:2016(E) ISO International Organization for Standardization @ IS0 2016 ed without license from IHS IS0/TR19024:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, Published in Switzerland All rights reserved. Unless otherwise specified, 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. IsOcopyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org PrganizationforStandardization etworking permitted without license from IHS IS0/TR 19024:2016(E) Contents Page Foreword ..iv Introduction. .. 1 Scope.. 2 Normative references 3 Terms and definitions 4 Abbreviated terms. ..2 5 Recommendations .2 5.1 General .2 5.2 Materials and methods .2 5.3 Results and verification of test .3 5.4 Components. .3 Annex A (informative) Rationale for the recommendations of this document. Bibliography .6 iii vided by IHS under ed without license from IHS