警告-其他要求和其他欧盟指令可能适用于产品 属于本标准的范围。本文件规定了血液透析器、血液透析过滤器、血液过滤器和血液过滤器的要求 用于人体的血液浓缩器，以下统称为“设备”。交叉引用:ISO 10993-1ISO 10993-11ISO 10993-4ISO 10993-7ISO 80369-7ISO 7000ISO 14937ISO 8637-2ISO 15223-1ISO 13485ISO 17665-1ISO 11137-3ISO/TS 17665-2ISO 15223-2ISO 11135ISO 11137-2ISO 11137-1购买本文件时提供的所有当前修订版均包括在内。

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.Cross References:ISO 10993-1ISO 10993-11ISO 10993-4ISO 10993-7ISO 80369-7ISO 7000ISO 14937ISO 8637-2ISO 15223-1ISO 13485ISO 17665-1ISO 11137-3ISO/TS 17665-2ISO 15223-2ISO 11135ISO 11137-2ISO 11137-1All current amendments available at time of purchase are included with the purchase of this document.