ISO INTERNATIONAL STANDARD 1135-5 Firstedition 2015-12-01 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus Materiel de transfusion d usage medical - Partie 5:Appareils de transfusionnon réutilisablesavec les appareils deperfusion sous pression Reference number IS01135-5:2015(E) LSO Intermational Organization for Standardization @IS02015 JIANG INSTOFSTANDARDIZATION C15956617 d without license from IHS IS01135-5:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS02015,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 +4122 749 09 47 copyright@iso.org www.iso.org Intemationaibr PrganizationforStandardization Licensee-ZHEJIANG INST OF STANDARDIZoISQ 3,5 - All rights reserved networking permited without license from IHS NotforResale, 2016/3/29 05:17:58 IS0 1135-5:2015(E) Contents Page Foreword ..iv 1 Scope ..1 2 Normativereferences 3 Terms and definitions 4 General requirements. .2 4.1 Nomenclatureforcomponents of thetransfusion set 2 4.2 Maintenance of sterility 5 Materials .3 6 Physical requirements. ..4 6.1 Particulate contamination .4 6.2 Leakage. .4 6.3 Tensile strength .4 6.4 Closure-piercing device .4 6.5 Tubing .5 6.6 Filterforblood and blood components .5 6.7 Drip chamber and drip tube.. .5 6.8 Flow regulator .5 6.9 Flow rate of blood and blood components .5 6.10 Injectionsite .6 6.11 Male conical fitting 6.12 Protective caps .6 6.13 Storage volume. ..6 7 Chemical requirements 7.1 Reducing (oxidizable) matter. .6 7.2 Metalions ..6 7.3 Titration acidity or alkalinity. .6 7.4 Residue on evaporation. ..6 7.5 UVabsorptionofextract solution .7 8 Biological requirements. .7 8.1 General .7 8.2 Sterility .7 8.3 Pyrogenicity .7 8.4 Haemolysis .7 8.5 Toxicity .1 8.6 Assessmentofbloodcomponentdepletion 8.7 Assessment of damagetoblood components .7 9 Labelling. .8 9.1 General ..8 9.2 Unit container ..8 9.3 Shelfor multi-unit container ...9 10 Packaging 11 Disposal. Annex A (normative) Physical tests ..10 AnnexB(normative)Chemicaltests .14 AnnexC (normative)Biological tests ..16 AnnexD(normative)Storagevolume ..17 Bibliography .20 ntemaional oganzation @sIS2015 - All rights reserved iii Licensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 No reproduction or networking permi ed without license from IHS