ISO INTERNATIONAL STANDARD 8637-3 First edition 2018-06 Extracorporealsystemsforblood purification - Part 3: Plasmafilters Systemes extracorporels pour la purification du sang- Partie3:Filtrespourplasma Reference number IS0 8637-3:2018(E) ISO @IS02018 IS08637-3:2018(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 ontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherIsoattheaddress beloworIso'smemberbodyinthecountryoftherequester. ISO copyright office CP 401: Ch.de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland i IS02018-Allrightsreserved IS08637-3:2018(E) Contents Page Foreword .iv Introduction. ... 1 Scope. ..1 2 Normativereferences 3 Terms and definitions ..1 4 Requirements .2 4.1 Biological safety .2 4.2 Sterility 3 4.3 Non-pyrogenicity 3 4.4 Mechanical characteristics .3 4.4.1 Structural integrity .3 4.4.2 Blood compartment integrity .3 4.4.3 Connectorsandports. 3 4.4.4 Volumeofthebloodcompartment .5 4.4.5 Pressuredropofthebloodcompartment 5 4.5 Performancecharacteristics. 5 4.5.1 Filtration rate. 5 4.5.2 Sieving coefficient .5 4.5.3 Haemolytic characteristics .6 4.6 Expiry date. .6 5 Test methods .6 5.1 General .6 5.2 Biological safety 6 5.3 Sterility .6 5.4 Non-pyrogenicity 6 5.5 Mechanical characteristics. .7 5.5.1 Structural integrity 7 5.5.2 Blood compartmentintegrity .7 5.5.3 Blood compartment ports .7 5.5.4 Blood compartment volume 7 5.6 Plasma filtrate port. .7 5.7 Pressure drop. .7 5.7.1 Test solution .7 5.7.2 Pressuredroptestprocedure 7 5.8 Performancecharacteristics. 8 5.8.1 Filtration rate. ..8 5.8.2 Sieving coefficient .8 5.8.3 Haemolyticcharacteristics 10 5.9 Expirydate 10 6 Labelling. .10 6.1 Labelling onthedevice .10 6.2 Labelling on unit containers. .11 6.3 Labellingontheoutercontainers. .11 6.4 Information to be given in the accompanying documentation ..12 Bibliography 14 @ IS0 2018 -All rights reserved ili