ISO INTERNATIONAL STANDARD 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use Part 4: Transfusion sets for single use, gravity feed Matériel de transfusion a usage médical - Partie 4: Appareils de transfusion non réutilisables a alimentation par gravité Reference number IS0 1135-4:2015(E) SO International Organization for Standardization @ IS0 2015 ed without license from IHS IS0 1135-4:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS02015,PublishedinSwitzerland 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. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax+412274909 47 [email protected] www.iso.org Intenationai br PrganizationforStandardization ensee-ZHEJIANG INST OF STANDARDIZRoISQ $,5 - All rights reserved I by IHS unde etworking permitted without license from IHS IS0 1135-4:2015(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references 3 General requirements. 3.1 Nomenclature for components of the transfusion set .2 3.2 Maintenance of sterility. .2 4 Materials 5 Physical requirements. .3 5.1 Particulate contamination .3 5.2 Leakage..... .3 5.3 Tensile strength 3 5.4 Closure-piercing device .3 5.5 Tubing. 4 5.6 Filter for blood and blood components. .4 5.7 Drip chamber and drip tube. 4 5.8 Flow regulator. .4 5.9 Flow rate of blood and blood components .4 5.10 Injectionsite .5 5.11 Male conical fitting 5.12 Protective caps. .5 6 Chemical requirements .5 6.1 Reducing (oxidizable) matter. 6.2 Metalions .5 6.3 Titration acidity or alkalinity. ..5 6.4 Residue on evaporation. .5 6.5 UV absorption of extract solution .5 7 Biological requirements. .6 7.1 General. .6 7.2 Sterility .6 7.3 Pyrogenicity .6 7.4 Haemolysis. .6 7.5 Toxicity. .6 7.6 Assessment ofblood componentdepletion. .6 7.7 Assessment of damage to blood components Labelling. 8 8.1 General. .7 8.2 Unit container 8.3 Shelf or multi-unit container .7 9 Packaging ..8 10 Disposal. ..8 Annex A (normative) Physical tests .9 Annex B (normative) Chemical tests .13 Annex C (normative) Biological tests ..15 Bibliography. ..16 iii See=ZHEJIANG INST OF STANDARDIZATION C1 5956617 ed without license from IHS