血液净化用体外系统第3部分:血浆过滤器

[中文适用范围]： 本文件规定了血浆过滤器的要求和试验方法，血浆过滤器是用于血浆置换治疗中从血液中分离血浆的装置。本文件规定了供人体使用的无菌、一次性血浆过滤器的要求，以下统称为“装置”。本文件不适用于： — 体外血液回路； — 血液透析器、血液透析过滤器、血液过滤器和血液浓缩器； — 血液灌流装置； — 血管通路装置； — 血泵； — 用于进行血浆分离的系统或设备。注 1：体外血液回路的要求在 ISO 8637-2 中规定。注 2：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在 ISO 8637-2 中规定。 [外文原描述]： This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to; — extracorporeal blood circuits; — haemodialysers, haemodiafilters, haemofilters and haemoconcentrators; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems or equipment intended to perform plasma separation. NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637-2. NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.