CSA序言这是CAN/CSA-Z8638《心血管植入物和人工器官——血液透析器、血液透析滤过器和血液滤过器的体外血液回路》的第一版，采用了同名ISO（国际标准化组织）标准8638（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。1.2血液透析器、血液过滤器和血液浓缩器的体外血液回路（采用ISO 8638:1989）。出版时，ISO 8638:2004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用于血液透析、血液透析滤过和血液滤过的一次性体外血液回路（以下简称“装置”）和（整体式和非整体式）传感器保护器的要求。本国际标准不适用于血液透析器、血液透析过滤器或血液过滤器、血浆过滤器、血液灌注设备、血管通路设备、血液泵、体外血液回路的压力监测器、- 空气检测设备——制备、维护或监测透析液的系统——用于进行血液透析、血液透析滤过、血液滤过或血液浓缩的系统。注:ISO 8637规定了血液透析器、血液透析过滤器、血液过滤器和血液浓缩器的要求。

CSA PrefaceThis is the first edition of CAN/CSA-Z8638, Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 8638 (second edition, 2004-10-01). It replaces the previous edition published in 1994 as CAN/CSA-Z364.1.2, Extracorporeal Blood Circuit for Haemodialysers, Haemofilters and Haemoconcentrators (adopted ISO 8638:1989). At the time of publication, ISO 8638:2004 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 single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.This International Standard is not applicable to- haemodialysers, haemodiafilters or haemofilters,- plasmafilters,- haemoperfusion devices,- vascular access devices,- blood pumps,- pressure monitors for the extracorporeal blood circuit,- air detection devices,- systems to prepare, maintain or monitor dialysing fluid,- systems intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.