ISO INTERNATIONAL STANDARD 1135-3 Second edition 2016-11-01 Transfusion equipment for medical use: Part 3: Blood-taking sets for single use Materiel de transfusion a usage medical- Partie3:Appareilsnonréutilisablespourprelevementsanguin Referencenumber IS0 1135-3:2016(E) ISO @ ISO 2016 Intermational Crganization for Standardization rovided by IHS under lic se with ISO IS01135-3:2016(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. ISO copyright office 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 Provided by IHS under networking permited without licanse from IHS IS0 1135-3:2016(E) Contents Page Foreword ..iv 1 Scope ..1 2 Normative references 3 General requirements 3.1 Types of sets .1 3.2 Blood taking assembly .2 3.3 Air-outlet assembly 2 ..3 3.4 Sterilization 3.5 Maintenance of sterility .3 4 Materials .3 5 Physical requirements .3 5.1 .3 Particulate contamination 5.2 Leakage. .3 5.3 Tensile strength .3 5.4 Bottleneedle .3 5.5 Air-outlet needle 3 .3 5.6 Blood-taking needle 5.7 Tubing. .4 5.8 Flow regulator 5.9 Protective caps. .4 6 Chemicalrequirements .4 6.1 Reducing (oxidizable) matter ..4 6.2 Metalions 4 6.3 Titration acidity or alkalinity. 6.4 Residue on evaporation 4 6.5 UV absorption of extract solution. .5 7 Biological requirements .5 7.1 General .5 7.2 Sterility .5 7.3 Pyrogenicity .5 7.4 Haemolysis .5 7.5 Toxicity .5 8 Labelling. .5 8.1 General .5 8.2 Unit container L. 8.3 Shelfor multi-unit container .6 9 Packaging .6 .6 10 Disposal. AnnexA (normative)Physicaltests .7 Annex B (normative) Chemical tests AnnexC (normative)Biologicaltests .11 Bibliography ..12 ili Provided by IHS under license with ISO ed without license from IHS