ISO/TR TECHNICAL 19727 REPORT First edition 2017-08 Medical devices Pump tube spallation test General procedure Dispositifs médicaux - Essai de spallation des tubes de pompes - Mode opératoire general Reference number ISO/TR19727:2017(E) ISO @IS02017 IS0/TR19727:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2017,Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form 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 ii @ IS0 2017 - All rights reserved IS0/TR 19727:2017(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references 3 Terms and definitions 4 Materials and equipment 5 Identification ..2 6 Preparation. .2 6.1 General .2 6.2 Pump set to be tested .2 7 Test setup ..2 8 Test method ..3 8.1 Sampling. .3 8.2 Analysing. ..4 9 Test conditions and acceptance criteria Bibliography .5 @ IS0 2017 - All rights reserved iii