CSA序言这是CAN/CSA-Z8637《心血管植入物和人工器官——血液透析器、血液透析过滤器、血液过滤器和血液浓缩器》的第一版，采用了同名ISO（国际标准化组织）标准8637（第二版，2004-10-01），但有加拿大的偏差。它取代了1994年出版的前一版CAN/CSA-Z364。1.1血液透析器、血液过滤器和血液浓缩器（采用ISO 8637:1989）。出版时，ISO 8637:2004仅提供英文版。 CSA将在ISO发布法文版。1范围本国际标准规定了供人类使用的血液透析器、血液透析过滤器、血液过滤器和血液浓缩器（以下统称为“设备”）的要求。本国际标准不适用于-体外血液回路，-血浆过滤器，-血液灌注装置，-血管通路装置，-血液泵，-体外血液回路的压力监测器，-空气检测装置，-制备、维护或监测透析液的系统- 用于执行血液透析、血液透析过滤、血液过滤或血液浓缩的系统，再处理程序和设备。注:ISO 8638规定了血液透析器、血液透析过滤器和血液过滤器的体外血液回路要求。

CSA PrefaceThis is the first edition of CAN/CSA-Z8637, Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 8637 (second edition, 2004-10-01). It replaces the previous edition published in 1994 as CAN/CSA-Z364.1.1, Haemodialysers, Haemofilters and Haemoconcentrators (adopted ISO 8637:1989). At the time of publication, ISO 8637:2004 is available from ISO in English only. CSA will publish the French version when it becomes available from ISO.1 ScopeThis International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use for humans.This lnternational Standard is not applicable to- extracorporeal blood circuits,- plasmafilters,- haemoperfusion devices,- vascular access devices,- blood pumps,- pressure monitors for the extracorporeal blood circuit,- air detection devices,- systems to prepare, maintain or monitor dialysate,- systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration,- reprocessing procedures and equipment.NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters are specified in ISO 8638.