TECHNICAL ISO/TS SPECIFICATION 23810 Third edition 2018-07 Cardiovascular implants and artificial organs Checklists for use of extracorporeal circulation equipment Implants cardiovasculaires et organes artificiels - Listes de controle pour I'eéquipement de circulation extracorporelle Referencenumber IS0/TS 23810:2018(E) ISO @ IS0 2018 IS0/TS 23810:2018(E) COPYRIGHTPROTECTEDDOCUMENT IS02018 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 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:+4122749 0111 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS0/TS23810:2018(E) Contents Page Foreword ..vi Introduction. ..vii 1 Scope. 2 Normative references 3 Terms and definitions 4 Preoperative requirements 4.1 Patient information. .1 .1 4.1.1 Rationale 4.1.2 Patient interview 2 .2 4.1.3 Patient identity 4.1.4 Medical record number 2 2222 4.1.5 Allergies. 4.1.6 Blood bank numbers 4.1.7 Blood type and antibodies 4.1.8 Chart. 23 4.1.9 Procedure. 4.2 Equipment and Instructions for Use 4.2.1 Rationale 33 4.2.2 Equipment 4.2.3 Instructions for Use. 3 .3 4.3 Sterility/cleanliness. 4.3.1 Rationale 3 4.3.2 Component package integrity/expiration dates 3 4.3.3 Serial/lot numbers. 3 4.3.4 Equipment. 3 4.3.5 Heat exchanger(s) .3 4.3.6 Maintenance 4 4.4 Pumps 4.4.1 Rationale 4 4.4.2 ..4 Electrical 4.4.3 Batteries 4 4.4.4 Rollerpumps .4 4.4.5 Centrifugal pumps 5 4.5 Cardioplegia. .5 4.5.1 Rationale 5 4.5.2 Solutions .5 4.5.3 Method of delivery 6 4.5.4 Heat exchangerleaks 6 4.5.5 Temperature control. .6 4.5.6 Bubble removal .6 4.5.7 Leak-free .6 4.6 Medical gas supply 6 4.6.1 Rationale .6 4.6.2 Circuitgas line(s) connection(s) 6 4.6.3 Source(s) and connections of gas(es) .6 4.6.4 Flow meter/gas blender. 6 4.6.5 Hoses .6 4.6.6 Gas exhaust 7 4.6.7 Inhalationalgasscavengeline .7 4.6.8 Oxygen sensor. 4.6.9 Operating pressures for gas sources .7 4.6.10 Gas filter 4.7 Vacuum supply 7 @ IS0 2018 -All rights reserved ili