ISO 13958:2009 血液透析及相关治疗用浓缩物

标准编号：ISO 13958:2009

中文名称：血液透析及相关治疗用浓缩物

英文名称：Concentrates for haemodialysis and related therapies

发布日期：2009-04

标准范围

ISO 13958:2009规定了血液透析和相关治疗用浓缩物的最低要求。在本国际标准中，“浓缩物”是指化学品和水的混合物，或干粉或其他高浓缩介质形式的化学品混合物，交付给最终用户，以制造用于血液透析和相关治疗的透析液。ISO 13958:2009针对此类浓缩物的制造商。在本国际标准的几个实例中，有必要对最终用户生产的透析液进行说明，以帮助澄清生产浓缩液的要求。由于浓缩液制造商对最终透析液没有控制权，因此提及透析液是为了澄清，而不是制造商的要求。ISO 13958:2009包括液体和粉末形式的浓缩物。还包括添加剂，也称为尖峰，可添加到浓缩液中的化学品，以增加浓缩液中一个或多个现有离子的浓度，从而增加最终透析液中的离子浓度。本国际标准还规定了在用户设施将酸和碳酸氢盐粉末混合成浓缩物的设备要求。

ISO 13958:2009 specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “concentrates” are a mixture of chemicals and water, or a mixture of chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies.ISO 13958:2009 is addressed to the manufacturer of such concentrates. In several instances in this International Standard, it became necessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.ISO 13958:2009 includes concentrates in both liquid and powder forms. Also included are additives also called spikes, chemicals which may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This International Standard also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.

标准预览图