标准编号:ISO 13960:2010

中文名称:心血管植入物和体外系统 血浆滤过器

英文名称:Cardiovascular implants and extracorporeal systems — Plasmafilters

发布日期:2010-07

标准范围

This International Standard specifies requirements for sterile, single-use plasmafilters, intended for use on humans. This International Standard does not apply to the extracorporeal circuits used for plasmapheresis or other extracorporeal blood exchange devices, such as haemodialysers, haemodiafilters, haemofilters, haemoperfusion devices, vascular access devices, oxygenators or active medical devices. This International Standard does not address the replacement fluid.

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