标准号：ISO 8637-2004
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、血液过滤器和血液浓缩器
英文名称：Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
发布日期：2004-10
被替代标准：ISO 8637-2010
代替标准：ISO 8637-1989;ISO/FDIS 8637-2004
采用标准：JIS T 3250-2005,MOD;CAN/CSA-Z8637-08-2008,NEQ
起草单位：ISO/TC 150
标准简介：This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use for humans.
This International 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.
文件格式：PDF
文件大小：296.24KB
文件页数：24
（以上信息更新时间为：2019-11-22）
ISO 8637-2004 心血管植入物和人造器官.血液透析器、血液透析过滤器、血液过滤器和血液浓缩器.pdf
(296.24 KB)
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