International ISO Standard ISO 8637-1 Second edition Extracorporeal systems for blood 2024-05 purification- Part 1: Haemodialysers,haemodiafilters, haemofilters and haemoconcentrators Systemes extracorporels pour la purification du sang- Partie I:Hemodialyseurs,hemodiafiltres,hemofiltres et hemoconcentrateurs Reference number ISO 8637-1:2024(en) @ ISO 2024 IS0 8637-1:2024(en) COPYRIGHT PROTECTED DOCUMENT ISO 2024 Al rights reserved.Unless otherwise specified,or required in the context of its implementation,no part of this publication may 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 CP401:Ch.de Blandonnet 8 CH-1214 Vernier,Geneva Phone:+41227490111 Email:copyright@iso.org Website: www.iso.org Published in Switzerland OISO 2024-All rights reserved ii ISO8637-1:2024( en) Contents Page Foreword Introduction Scope 1 2 Normative references 3 Terms and definitions Requirements 4 Biological safety and haemocompatibility 4.1 4.2 Sterility ..... 4.3 Non-pyrogenicity 4.4 Mechanical characteristics 4.4.1 Structural integrity 4.4.2 Blood compartment integrity ..6 4.4.3 Blood compartment of haemodialysers , haemodiafilters connectors and haemofilters ....... 4.4.4 Dialysis fluid compartment connectors of haemodialysers and haemodiafilters ....... Filtrate connectors ofhaemofilters . 4.4.5 X 4.4.6 Blood and filtrate connectors of haemoconcentrators 4.5 Performance characteristics 4.5.1 Solute clearance for haemodialysers and haemodiafilters 4.5.2 Sieving coefficients for haemodialysers , haemodiafilters , haemofilters and haemoconcentrators 4.5.3 Ultrafiltration rate 4.5.4 Ultrafiltration coefficient 9 4.5.5 Blood compartment volume 4.5.6 Blood compartment pressuredrop Endotoxin transfer ofhaemodialysers and haemodiafilters 4.5.7 4.6 Expiry date 10 5 Test methad. s. 10 5.1 General 10 5.2 Biological safety and haemocompatibility 11 5.3 Sterility 11 5.4 Non-pyrogenicity 11 5.5 Mechanical characteristics 11 5.5.1 Structural integrity 5.5.2 Blood compartment integrity 12 5.5.3 Connectors 12 5.6 Performance characteristics .16 5.6.1 Solute clearance ofhaemodialysers and haemodiafilters 16 5.6.2 Sieving coefficient of haemodialysers ， haemodiafilters ， haemofilters and haemoconcentrators 5.6.3 Ultrafiltration rate 21 5.6.4 Ultrafiltration coefficient 21 5.6.5 Blood compartment volume 21 5.6.6 Blood compartment pressure drop 5.6.7 Endotoxin transfer ofhaemodialysers and haemodiafilters 22 Expiry date 6 22 7 Labelling 7.1 Labelling on the device 7.2 Labelling on unit containers 23 7.3 Labelling on the outer containers .23 7.4 Information to be given in the accompanying documentation 24 8 Packaging ISO 2024-Allrights reserved ii