标准编号：ISO 8637-1:2024
中文名称：血液净化用体外系统 第1部分：血液透析器、血液透析滤过器、血液滤过器和血液浓缩器
英文名称：Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
发布日期：2024-05
标准范围
This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to: — extracorporeal blood circuits; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; — reprocessing procedures and equipment. NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
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