ISO INTERNATIONAL STANDARD 8637-1 First edition 2017-11 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Systemes extracorporels pour la purification du sang - Partie 1: Hemodialyseurs, hemodiafiltres, hemofiltres et hémoconcentrateurs Reference number IS0 8637-1:2017(E) ISO @IS0 2017 Provided by IHS Markit under license with ANSI IS0 8637-1:2017(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form writtenpermission.PermissioncanberequestedfromeitherIsOattheaddressbeloworIsO'smemberbodyinthecountryof 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 copyright@iso.org www.iso.org ii @IS0 2017 - All rights reserved Provided by IHS Markit under iense with ANSI IS0 8637-1:2017(E) Contents Page Foreword .iv Introduction. V 1 Scope. 1 2 Normative references. 3 Terms and definitions. 4 Requirements. 4.1 Biological safety. 4.2 Sterility. 4.3 Non-pyrogenicity ... 4.4 Mechanical characteristics 4.4.1 Structuralintegrity 4.4.2 Blood compartment integrity 4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports. 4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports.... 4.4.5 Haemofilterfiltrateports.. 8 4.4.6 Haemoconcentrator blood and filtrate ports. 8 4.5 Performance characteristics... 8 4.5.1 Solute clearance of haemodialysers and haemodiafilters 4.5.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators 4.5.3 Ultrafiltration coefficient... 4.5.4 Volume of the blood compartment.. 4.5.5 Pressure drop of the blood compartment. 4.6 Expiry date. 9 5 Test methods. 9 5.1 General 5.2 Biological safety 10 5.3 Sterility 10 5.4 Non-pyrogenicity 10 5.5 Mechanical characteristics 10 5.5.1 Structural integrity. 10 5.5,2 Blood compartment integrity.. 5.5.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports.. 11 5.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports. 11 5.5.5 Haemofilter filtrate ports. 11 5.5.6 Haemoconcentrator blood and filtrate ports. 1 5.6 Performance characteristics... 13 5.6,1 Clearance 13 5.6.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators ... 15 5.6.3 Ultrafiltration coefficient... 16 5.6.4 Volume of the blood compartment. 17 5.6.5 Pressure drop of the blood compartment. 5.7 Expiry date.. 6 Labelling.. .17 6.1 Labelling on the device . 17 6.2 Labelling on unit containers. 6.3 Labelling on the outer containers. 18 6.4 Information to be given in the accompanying documentation 19 Bibliography 22 @ IS0 2017 - All rights reserved ili Provided by IHS Markit under license with ANSI