标准号：ISO 8638-2004
实施状态：作废
中文名称：心血管植入物和人造器官.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
英文名称：Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
发布日期：2004-10
被替代标准：ISO 8638-2010
代替标准：ISO 8638-1989;ISO/FDIS 8638-2004
采用标准：CAN/CSA-Z8638-08-2008,NEQ
起草单位：ISO/TC 150
标准简介：This 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.
文件格式：PDF
文件大小：172.49KB
文件页数：20
（以上信息更新时间为：2019-11-22）
ISO 8638-2004 心血管植入物和人造器官.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.pdf
(172.49 KB)
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